Abbott Medical
Burlington, MA, US
Abbott Medical appears in FDA device records in Burlington, MA. FDA records list 1,478 510(k) clearances between and , 5,012 PMA records and 40 registered establishments. As of , FDA records show 2,479 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
39 namesFDA records resolved to Abbott Medical carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Abbott Diabetes Care, Inc.registration, 510(k), PMA, enforcement report, recall
- Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CArecall
- Abbott GmBH & Co. KGenforcement report, recall
- Abbott Laboratories Diagnostic Divrecall
- Abbott Laboratories HPD/ADDrecall
- Abbott Laboratories HPD/ADD/GPRDrecall
- Abbott Laboratories Inc. (St Jude Medical)enforcement report, recall
- Abbott Laboratories Medisense Productsrecall
- Abbott Laboratories MPGrecall
- Abbott Laboratories, Inc.registration, 510(k), PMA, enforcement report, recall
- Abbott Point of Care, Inc.registration, 510(k), enforcement report, recall
- Abbott S.r.l.registration, 510(k), PMA, enforcement report, recall
- Advanced Neuromodulation Systems510(k), enforcement report, recall
- Aga Medical Corporation510(k), recall
- Deltec, Inc.510(k), recall
- Ep Medsystems, Inc.510(k), recall
- Hospira Inc., A Pfizer Companyenforcement report, recall
- Hospira, Inc.registration, 510(k), PMA, enforcement report, recall
- ICUrecall
- Icu Medical, Inc.registration, 510(k), enforcement report, recall
- Laborie Medical Technologies Correcall
- Laborie Medical Technologies, Ltd.registration, 510(k), enforcement report, recall
- Labories Medical Technologiesenforcement report, recall
- Portex, Inc.510(k), recall
- Sims Portex, Inc.510(k), recall
- Smiths Medical510(k), recall
- Smiths Medical Asd, Inc.510(k), PMA, enforcement report, recall
- Smiths Medical International , Ltd.510(k), recall
- Smiths Medical MD, Inc.510(k), recall
- Smiths Medical Pm, Inc.510(k), recall
- St Jude Medical, Crmd510(k), recall
- St. Jude Medicalregistration, 510(k), PMA, enforcement report, recall
- St. Jude Medical Cardiovascular Divisionrecall
- St. Jude Medical, Atrial Fibrillation Division, Inc.registration, enforcement report, recall
- St. Jude Medical, Cardiac Rhythm Management Divisionenforcement report, recall
- St. Jude Medical, Cardian Rhythm Management Divisionenforcement report, recall
- St. Jude Medical, Cardiology Division, Inc.registration
- St. Jude Medical, Daig Division, Inc.510(k), recall
- Thoratec Corporationregistration, 510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 1,478FDA records hold 1,478 510(k) clearances for Abbott Medical between 1976 and 2026. The busiest year on record is 1998, with 74. The most recent is 2026, with 15.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 5 |
| 1977 | 33 |
| 1978 | 16 |
| 1979 | 26 |
| 1980 | 31 |
| 1981 | 26 |
| 1982 | 19 |
| 1983 | 38 |
| 1984 | 34 |
| 1985 | 42 |
| 1986 | 41 |
| 1987 | 41 |
| 1988 | 55 |
| 1989 | 51 |
| 1990 | 37 |
| 1991 | 28 |
| 1992 | 27 |
| 1993 | 20 |
| 1994 | 45 |
| 1995 | 47 |
| 1996 | 28 |
| 1997 | 22 |
| 1998 | 74 |
| 1999 | 29 |
| 2000 | 24 |
| 2001 | 19 |
| 2002 | 35 |
| 2003 | 34 |
| 2004 | 38 |
| 2005 | 30 |
| 2006 | 44 |
| 2007 | 40 |
| 2008 | 41 |
| 2009 | 41 |
| 2010 | 26 |
| 2011 | 18 |
| 2012 | 25 |
| 2013 | 19 |
| 2014 | 17 |
| 2015 | 20 |
| 2016 | 21 |
| 2017 | 17 |
| 2018 | 16 |
| 2019 | 10 |
| 2020 | 14 |
| 2021 | 14 |
| 2022 | 15 |
| 2023 | 29 |
| 2024 | 17 |
| 2025 | 24 |
| 2026 | 15 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262006 | EnSite™ X EP System | DQK | Substantially Equivalent | |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | DQY | Substantially Equivalent | |
| K261039 | i-STAT Crea cartridge with the i-STAT 1 System | CGL | Substantially Equivalent | |
| K261631 | Amplatzer TorqVue Exchange System | DQY | Substantially Equivalent | |
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | MMI | Substantially Equivalent | |
| K252424 | Anti-HCV Next | MZO | Substantially Equivalent | |
| K260993 | Amplatzer TorqVue Delivery System | DQY | Substantially Equivalent | |
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | NQQ | Substantially Equivalent | |
| K260212 | EnSite™ X EP System | DQK | Substantially Equivalent | |
| K253907 | Disposable Radiofrequency Cannula | GXI | Substantially Equivalent | |
| K252130 | LifeShield Infusion Safety Software Suite | PHC | Substantially Equivalent | |
| K252006 | OTTO™ Disinfecting Cap | QBP | Substantially Equivalent | |
| K251980 | ClaveQS™ Bag | KPE | Substantially Equivalent | |
| K260499 | Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | DQY | Substantially Equivalent | |
| K252512 | Armada™ 14 NC PTA Catheter | LIT | Substantially Equivalent | |
| K253516 | Assert-IQ (DM5100) | MXD | Substantially Equivalent | |
| K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | DQY | Substantially Equivalent | |
| K253232 | Seguin Annuloplasty Ring | KRH | Substantially Equivalent | |
| K250031 | Amplatzer Guidewire | DQX | Substantially Equivalent | |
| K252013 | EnSite™ X EP System | DQK | Substantially Equivalent | |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | MXD | Substantially Equivalent | |
| K251463 | EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | DQK | Substantially Equivalent | |
| K251234 | EnSite™ X EP System | DQK | Substantially Equivalent | |
| K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | DQX | Substantially Equivalent | |
| K243500 | ARCHITECT iGentamicin | LCD | Substantially Equivalent | |
| K243168 | Alinity i Rubella IgG | LFX | Substantially Equivalent | |
| K250616 | Clave™ Neutral-Displacement Needlefree Connectors | FPA | Substantially Equivalent | |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | GXI | Substantially Equivalent | |
| K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ | OBJ | Substantially Equivalent | |
| K251231 | ViewFlex™ X ICE Catheter, Sensor Enabled™ | OBJ | Substantially Equivalent | |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | CHL | Substantially Equivalent | |
| K250426 | Amulet™ Steerable Delivery Sheath | DQY | Substantially Equivalent | |
| K243549 | JETi Hydrodynamic Thrombectomy System | QEZ | Substantially Equivalent | |
| K242117 | LifeShield Infusion Safety Software Suite | PHC | Substantially Equivalent | |
| K242115 | Plum Duo™ Precision IV Pump | FRN | Substantially Equivalent | |
| K242114 | Plum Solo™ Precision IV Pump | FRN | Substantially Equivalent | |
| K243283 | Alinity h-series System | GKZ | Substantially Equivalent | |
| K243985 | Rio™ Drug Reconstitution Transfer Device | LHI | Substantially Equivalent | |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | MMI | Substantially Equivalent | |
| K243224 | MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801) | DQY | Substantially Equivalent | |
| K243493 | Agilis NxT Steerable Introducer Dual-Reach | DYB | Substantially Equivalent | |
| K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | DQX | Substantially Equivalent | |
| K233932 | Alinity i Toxo IgM | LGD | Substantially Equivalent | |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | FBK | Substantially Equivalent | |
| K241538 | TriClip Steerable Guide Catheter | DQY | Substantially Equivalent | |
| K242016 | EnSite™ X EP System | DQK | Substantially Equivalent | |
| K241372 | Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ | MTD | Substantially Equivalent | |
| K241370 | Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) | DYB | Substantially Equivalent | |
| K233861 | Libre Rio Continuous Glucose Monitoring System | SBH | Substantially Equivalent | |
| K232943 | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe | QNQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2954323 | 3002803444 | ABBOTT DIABETES CARE INC. | 1360 SOUTH LOOP RD., ALAMEDA, CA 94502 US | 2026 | and 7 more, listed in full below |
| 9710492 | 3003500908 | ABBOTT DIABETES CARE LIMITED | RANGE RD., WITNEY OXON Oxfordshire OX29 0YL GB | 2026 | |
| 3002809144 | 3002809144 | ABBOTT GmbH | Max-Planck-Ring 2, Wiesbaden Hesse 65205 DE | 2026 | and 127 more, listed in full below |
| 1415939 | 1415939 | ABBOTT LABORATORIES | 100 ABBOTT PARK RD., Abbott Park, IL 60064 US | 2026 | and 6 more, listed in full below |
| 1451914 | 1451914 | ABBOTT LABORATORIES | U.S. 41/MARTIN LUTHER KING DR., North Chicago, IL 60064 US | 2026 | No device listings on this registration |
| 1628664 | 1628664 | ABBOTT LABORATORIES | 1921 Hurd Dr, IRVING, TX 75038 US | 2026 | |
| 2919069 | 2919069 | ABBOTT LABORATORIES | 647 Almanor Ave., Sunnyvale, CA 94085 US | 2026 | |
| 3005333358 | 3005333358 | ABBOTT LABORATORIES | Conway Park, Lake Forest, IL 60045 US | 2026 | and 182 more, listed in full below |
| 3016438761 | 3016438761 | ABBOTT LABORATORIES | 1915 Hurd Drive, Irving, TX 75038 US | 2026 | and 61 more, listed in full below |
| 2017865 | 2017865 | ABBOTT MEDICAL | 15900 Valley View Court, Sylmar, CA 91342 US | 2026 | and 23 more, listed in full below |
| 3013288201 | 3013288201 | ABBOTT MEDICAL | 14901 Deveau Pl. Building 2, Minnetonka, MN 55345 US | 2026 | and 12 more, listed in full below |
| 2245578 | 2245578 | ABBOTT POINT OF CARE INC. | 400 College Road East, Princeton, NJ 08540 US | 2026 | and 12 more, listed in full below |
| 1627487 | 1627487 | Abbott Medical | 6901 Preston Rd, PLANO, TX 75024 US | 2026 | and 4 more, listed in full below |
| 2135147 | 3005334138 | Abbott Medical | 5050 NATHAN LANE NORTH, Plymouth, MN 55442 US | 2026 | and 12 more, listed in full below |
| 2648612 | 2648612 | Abbott Medical | LOT 20 B Street, Caguas, PR 00725 US | 2026 | |
| 3004936110 | 3004936110 | Abbott Medical | 387 Nerem St Nw Ste 500, Atlanta, GA 30313 US | 2026 | |
| 3006705815 | 3006705815 | Abbott Medical | LOT A INTERIOR - No. 2 RD KM 67.5, Arecibo, PR 00612 US | 2026 | and 11 more, listed in full below |
| 3007113487 | 3007113487 | Abbott Medical | 177 County Road B East, Saint Paul, MN 55117 US | 2026 | and 11 more, listed in full below |
| 3008494315 | 3008377825 | Abbott Medical | Plot 102, Lebuhraya Kampung Jawa, Penang Pulau Pinang 11900 MY | 2026 | and 5 more, listed in full below |
| 3009600098 | 3009600098 | Abbott Medical | 4 Robbins Rd, Westford, MA 01886 US | 2026 | |
| 3011706799 | 3011706799 | Abbott Medical | 1850 MacArthur Blvd NW, Atlanta, GA 30318 US | 2026 | |
| 3020950818 | 3020950818 | Abbott Medical | 1820 Bastian Court, Westfield, IN 46074 US | 2026 | |
| 3004032053 | 3004032053 | Abbott S.r.l. | Viale Thomas Alva Edison, 110, Milan Lombardy 20099 IT | 2026 | |
| 1925262 | 1925262 | HOSPIRA, INC. | 1776 NORTH CENTENNIAL DR., MCPHERSON, KS 67460 US | 2026 | |
| 1713468 | 1713468 | ICU MEDICAL, INC | 4455 ATHERTON DR., Salt Lake City, UT 84123 US | 2026 | and 18 more, listed in full below |
| 2024064 | 2024064 | ICU MEDICAL, INC. | 13520 EVENING CREEK DRIVE NORTH, SAN DIEGO, CA 92128 US | 2026 | |
| 2025816 | 2025816 | ICU MEDICAL, INC. | 951 CALLE AMANECER, SAN CLEMENTE, CA 92673 US | 2026 | and 82 more, listed in full below |
| 3013319212 | 3013319212 | ICU MEDICAL, INC. | 600 N Field Dr, Lake Forest, IL 60045 US | 2026 | and 22 more, listed in full below |
| 1219611 | 1219611 | ICU Medical, Inc. | 201 W Queen St, SOUTHINGTON, CT 06489 US | 2026 | |
| 1526863 | 1526863 | ICU Medical, Inc. | 6250 Shier Rings Rd, DUBLIN, OH 43016 US | 2026 | and 30 more, listed in full below |
| 3008818980 | 3008818980 | ICU Medical, Inc. | 9124 Polk Lane, Suite 101, Olive Branch, MS 38654 US | 2026 | |
| 3027579175 | 3027579175 | ICU Medical, Inc. | 2625 Main St, Highland, IN 46322 US | 2026 | |
| 3017448360 | 3017448360 | LABORIE MEDICAL TECHNOLOGIES CORP. | 180 International Drive, Portsmouth, NH 03801 US | 2026 | and 4 more, listed in full below |
| 3012179728 | 3012179728 | St. Jude Medical | 2305 Walnut Street, Roseville, MN 55113 US | 2026 | and 22 more, listed in full below |
| 2182269 | 2182269 | St. Jude Medical, Atrial Fibrillation Division, Inc. | 14901 DEVEAU PL., Minnetonka, MN 55345 US | 2026 | and 5 more, listed in full below |
| 2184149 | 1000139754 | St. Jude Medical, Atrial Fibrillation Division, Inc. | One St. Jude Medical Drive, Saint Paul, MN 55117 US | 2026 | and 7 more, listed in full below |
| 3005334138 | 3005334138 | St. Jude Medical, Cardiology Division, Inc. | 5050 Nathan Lane North, Plymouth, MN 55442 US | 2026 | and 33 more, listed in full below |
| 1218444 | 1218444 | THORATEC CORP | 23 4th Ave, BURLINGTON, MA 01803 US | 2026 | |
| 2916596 | 2916596 | THORATEC CORP. | 6035 Stoneridge Dr, PLEASANTON, CA 94588 US | 2026 | and 1 more, listed in full below |
| 3008792657 | 3008792657 | Thoratec Corporation | 4550 Norris Canyon Rd, San Ramon, CA 94583 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBLAbsorbent, Carbon-Dioxide
- CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
- CDOAcid, Uric, Uricase (U.V.)
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- CAZAnesthesia Conduction Kit
- CBTArterial Blood Sampling Kit
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BTCBag, Reservoir
- CCOBed, Rocking, Breathing Assist
- CBDBottle, Collection, Breathing System (Calibrated)
- CATCannula, Nasal, Oxygen
- BSOCatheter, Conduction, Anesthetic
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- BSKCuff, Tracheal Tube, Inflatable
- CBHDevice, Fixation, Tracheal Tube
- CDSElectrode, Ion Specific, Urea Nitrogen
- CAHFilter, Bacterial, Breathing-Circuit
- BSNFilter, Conduction, Anesthetic
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- CCWLaryngoscope, Rigid
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- BXRMeter, Airway Pressure (Inspiratory Force)
- CAKMicrofilter, Blood Transfusion
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BZQMonitor, Breathing Frequency
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- BWCNeedle, Emergency Airway
- BYIPercussor, Powered-Electric
- CDDRadioassay, Vitamin B12
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- CANRegulator, Pressure, Gas Cylinder
- BWFSpirometer, Therapeutic (Incentive)
- BZWStethoscope, Esophageal
- BZTStethoscope, Esophageal, With Electrical Conductors
- BSRStylet, Tracheal Tube
- BYYTube, Aspirating, Flexible, Connecting
- BTSTube, Bronchial (W/Wo Connector)
- BSSTube, Nasogastric
- BTRTube, Tracheal (W/Wo Connector)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- BYXTubing, Pressure And Accessories
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- CBPValve, Non-Rebreathing
- CBKVentilator, Continuous, Facility Use
- BTMVentilator, Emergency, Manual (Resuscitator)
- BTLVentilator, Emergency, Powered (Resuscitator)
- BSBWarmer, Blood, Non-Electromagnetic Radiation
Recall records
Showing 25 of 2,479| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2759-2026 | Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70 | ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond. | Class II | Open, Classified | |
| Z-2724-2026 | ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. | Class II | Open, Classified | |
| Z-2723-2026 | ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. | Class II | Open, Classified | |
| Z-2669-2026 | Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14); | Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed. | Class II | Open, Classified | |
| Z-2520-2026 | Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture. Component: Yes, HeartMate 3" System Controller | Due to 11 volt Backup Battery failures. | Class II | Open, Classified | |
| Z-2519-2026 | Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 Left Ventricular System (LVAS) Kits | Due to 11 volt Backup Battery failures. | Class II | Open, Classified | |
| Z-2518-2026 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: No | Due to 11 volt Backup Battery failures. | Class II | Open, Classified | |
| Z-2405-2026 | Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software | Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. | Class II | Open, Classified | |
| Z-2313-2026 | Plum Duo Precision IV Pump, 40002-0403 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. | Class II | Open, Classified | |
| Z-2312-2026 | Plum Duo Infusion Pump, 40002-0401 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. | Class II | Open, Classified | |
| Z-2311-2026 | Plum Solo Precision IV Pump, 40001-0401 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. | Class II | Open, Classified | |
| Z-2001-2026 | i-STAT G3+ cartridge; List Number: 03P78-26; | Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems. | Class II | Open, Classified | |
| Z-2000-2026 | i-STAT EG6+ cartridge; List Number: 03P77-25; | Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems. | Class II | Open, Classified | |
| Z-1999-2026 | i-STAT EG7+ cartridge; List Number: 03P76-25; | Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems. | Class II | Open, Classified | |
| Z-2210-2026 | Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960 | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible. | Class II | Open, Classified | |
| Z-1101-2026 | Portex Spinal Tray, Item No. A3729-24 A3595 | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery. | Class II | Open, Classified | |
| Z-1100-2026 | Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery. | Class II | Open, Classified | |
| Z-1111-2026 | Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 | Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body | Class II | Open, Classified | |
| Z-1094-2026 | Plum Duo Infusion System, List Number 40002-04-01 | ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs. | Class II | Open, Classified | |
| Z-1120-2026 | ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed. | Class II | Open, Classified | |
| Z-1119-2026 | ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines) | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed. | Class II | Open, Classified | |
| Z-1118-2026 | ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed. | Class II | Open, Classified | |
| Z-1023-2026 | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | Class I | Open, Classified | |
| Z-1022-2026 | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | Class I | Open, Classified | |
| Z-1021-2026 | FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | Class I | Open, Classified |
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