Edwards Lifesciences LLC
Irvine, CA, US
EDWARDS LIFESCIENCES LLC appears in FDA device records in Irvine, CA. FDA records list 165 510(k) clearances between and , 1,178 PMA records and 5 registered establishments. As of , FDA records show 189 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Edwards Lifesciences LLC 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.
- CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AGregistration
- Edward Lifesciences510(k), enforcement report, recall
- Edwards Lifesciences Research Medical510(k), recall
510(k) clearance history
Showing 50 of 165FDA records hold 165 510(k) clearances for Edwards Lifesciences LLC between 1979 and 2026. The busiest year on record is 2024, with 11. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1998 | 1 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 5 |
| 2003 | 9 |
| 2004 | 6 |
| 2005 | 6 |
| 2006 | 7 |
| 2008 | 3 |
| 2009 | 5 |
| 2010 | 7 |
| 2011 | 7 |
| 2012 | 7 |
| 2013 | 7 |
| 2014 | 10 |
| 2015 | 6 |
| 2016 | 7 |
| 2017 | 4 |
| 2018 | 6 |
| 2019 | 6 |
| 2020 | 6 |
| 2021 | 4 |
| 2022 | 6 |
| 2023 | 9 |
| 2024 | 11 |
| 2025 | 9 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | PZX | Substantially Equivalent | |
| K251326 | Respiration Rate algorithm | BZQ | Substantially Equivalent | |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | DXC | Substantially Equivalent | |
| K254279 | Edwards eSheath+ introducer set | DYB | Substantially Equivalent | |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | DQK | Substantially Equivalent | |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | DQK | Substantially Equivalent | |
| K253034 | HemoSphere Stream Module | DQK | Substantially Equivalent | |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | KRH | Substantially Equivalent | |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | KRH | Substantially Equivalent | |
| K252364 | Edwards eSheath Optima introducer set | DYB | Substantially Equivalent | |
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | DQK | Substantially Equivalent | |
| K242518 | Hypertension Prediction Index (HePI) Algorithm | QAQ | Substantially Equivalent | |
| K244046 | Edwards eSheath Optima introducer set | DYB | Substantially Equivalent | |
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | DRS | Substantially Equivalent | |
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | DYG | Substantially Equivalent | |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm | MUD | Substantially Equivalent | |
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | DXE | Substantially Equivalent | |
| K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | QMS | Substantially Equivalent | |
| K241330 | Fogarty Fortis Arterial Embolectomy Catheter | DXE | Substantially Equivalent | |
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) | DYG | Substantially Equivalent | |
| K233824 | Swan-Ganz catheter | DYG | Substantially Equivalent | |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate Valve | DXE | Substantially Equivalent | |
| K233819 | Fogarty Venous Thrombectomy Catheters | DXE | Substantially Equivalent | |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | DXE | Substantially Equivalent | |
| K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); | DWF | Substantially Equivalent | |
| K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | MUD | Substantially Equivalent | |
| K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One) | DQK | Substantially Equivalent | |
| K230919 | Acumen IQ finger cuff | DXN | Substantially Equivalent | |
| K230579 | Smart Wedge algorithm | DQK | Substantially Equivalent | |
| K231038 | Global Hypoperfusion Index (GHI) Algorithm | QNL | Substantially Equivalent | |
| K231035 | FusedCO Algorithm | DQK | Substantially Equivalent | |
| K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor | DQK | Substantially Equivalent | |
| K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | QAQ | Substantially Equivalent | |
| K223651 | Cerebral Adaptive Index (CAI) Algorithm | MUD | Substantially Equivalent | |
| K222216 | TruWave Disposable Pressure Transducer | DXO | Substantially Equivalent | |
| K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) | DQK | Substantially Equivalent | |
| K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | DXN | Substantially Equivalent | |
| K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | DXF | Substantially Equivalent | |
| K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote | DQK | Substantially Equivalent | |
| K211610 | Fogarty Occlusion Catheter | MJN | Substantially Equivalent | |
| K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | QAQ | Substantially Equivalent | |
| K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index | DQK | Substantially Equivalent | |
| K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | MUD | Substantially Equivalent | |
| K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | DXN | Substantially Equivalent | |
| DEN190029 | Acumen Assisted Fluid Management (AFM) Software Feature | QMS | Unknown | |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | DXE | Substantially Equivalent | |
| K200499 | QuickDraw Venous Cannula | DWF | Substantially Equivalent | |
| K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula | DWF | Substantially Equivalent | |
| K200258 | Edwards eSheath Introducer Set | DYB | Substantially Equivalent | |
| K193466 | Swan-Ganz Catheters | DYG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615817 | 3003081151 | CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG | PARQUE INDUSTRIAL ITABO, HAINA San Cristobal -- DO | 2026 | and 13 more, listed in full below |
| 2015691 | 2015691 | EDWARDS LIFESCIENCES LLC | ONE EDWARDS WAY, IRVINE, CA 92614 US | 2026 | and 13 more, listed in full below |
| 3015287573 | 3015287573 | Edwards Lifesciences | Zona Franca La Lima, De la entrada de Pequeno Mundo 100 mts oeste y 200 mts sur, Guadalupe Cartago 30106 CR | 2026 | |
| 3008500478 | 1713910 | Edwards Lifesciences LLC | 12050 Lone Peak Parkway, Draper, UT 84020 US | 2026 | and 11 more, listed in full below |
| 3015179394 | 3015179394 | Edwards Lifesciences LTD | 10 Earhart Ave, Shannon Clare V14 P638 IE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- NPTAortic Valve, Prosthesis, Percutaneously Delivered
- DQRCannula, Catheter
- OFDCatheter Introducer Kit
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- KRACatheter, Continuous Flush
- DXECatheter, Embolectomy
- DYGCatheter, Flow Directed
- MJNCatheter, Intravascular Occluding, Temporary
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DQECatheter, Oximeter, Fiber-Optic
- DQYCatheter, Percutaneous
- DXFCatheter, Septostomy
- GDJClamp, Surgical, General & Plastic Surgery
- DXCClamp, Vascular
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- FLLContinuous Measurement Thermometer
- DREDilator, Vessel, For Percutaneous Catheterization
- LDFElectrode, Pacemaker, Temporary
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- GDZHandle, Scalpel
- LWQHeart-Valve, Mechanical
- LWRHeart-Valve, Non-Allograft Tissue
- DTJHolder, Heart-Valve, Prosthesis
- GDGHook, Surgical, General & Plastic Surgery
- HCFInstrument, Ligature Passing And Knot Tying
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- NKMMitral Valve Repair Devices
- BZQMonitor, Breathing Frequency
- JEZMonitor, Lung Water Measurement
- MUDOximeter, Tissue Saturation
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- NPWPercutaneously Delivered Prostheses And Tricuspid Valves
- DSBPlethysmograph, Impedance
- GEXPowered Laser Surgical Instrument
- KRBProbe, Thermodilution
- NPUProsthesis, Mitral Valve, Percutaneously Delivered
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
- NPVPulmonary Valve Prosthesis Percutaneously Delivered
- DYEReplacement Heart-Valve
- GADRetractor
- KRHRing, Annuloplasty
- FPASet, Administration, Intravascular
- DTISizer, Heart-Valve, Prosthesis
- GAESnare, Surgical
- MWSStabilizer, Heart
- FOXStand, Infusion
- FGEStents, Drains And Dilators For The Biliary Ducts
- FMGStopcock, I.V. Set
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DRSTransducer, Blood-Pressure, Extravascular
- DXOTransducer, Pressure, Catheter Tip
- FSMTray, Surgical, Instrument
- MGZValvulotome
Recall records
Showing 25 of 189| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2172-2026 | Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. | Class II | Open, Classified | |
| Z-2085-2025 | Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. | Class I | Open, Classified | |
| Z-2084-2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. | Class I | Open, Classified | |
| Z-2083-2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. | Class I | Open, Classified | |
| Z-2082-2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. | Class I | Open, Classified | |
| Z-2081-2025 | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. | Class I | Open, Classified | |
| Z-2080-2025 | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No. | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. | Class I | Open, Classified | |
| Z-0414-2024 | TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in (160cm); PXVMP3X32: x3 (3cc)/VAMP 75in (190cm); PXVP0041: (3cc)/VAMP Plus 96in (244cm); PXVP0550: x3 (3cc)/VAMP Plus 91 in (231cm); PXVP1071: x3 (3cc)/VAMP Plus 87in (221cm); PXVP1087: x4(3cc)/VAMP Plus; PXVP2260: (3cc)/VAMP Plus 60in (150cm); PXVP2272: (3cc)/VAMP Plus 72in (180cm); PXVP2284: (3cc)/VAMP Plus 84in (210cm); PXVP2284AT3: (3cc)/VAMP Plus 84in (210cm); PXVP23X3: x3: (3cc)/VAMP Plus; PXVP23X3AT3: x3 (3cc)/VAMP Plus; PXVP2X2AT3: x2 (3cc)/VAMP Plus; PXVPL0111: (3cc)/VAMP Plus 84in (213cm); PXVMP160: 3cc/VAMP 60 in (150cm); PXVMP172: 3cc/VAMP 72in)180cm); PXVMP184:3cc/VAMP 84in (210cm); PXVMP260:3cc/VAMP 60in (150cm); PXVFL10017: (3cc)/VAMP Flex 83in (210cm); PXVP0034: (3cc)/VAMP Plus 87in (220cm); T001691A: (3cc)/VAMP Plus; T001691M: (3cc)/VAMP Plus (215cm); T001744M:(3cc)/VAMP 93in (236 cm); T100671M: x3(3cc)/VAMP Plus (215cm); T001760A :x2(3cc)/VAMP Plus; T001765A: (3cc)/60in (150cm); T005021M: (3cc)/VAMP Flex (195cm); T005089M: x2 (3cc)/VAMP Flex (195 cm) ; T005091M: x3(3cc)/VAMP Flex (195cm); T434501B: x2(3cc)/VAMP 88in (225cm); T440B26B: x2 (3cc)/VAMP 88in (225cm); T450545A: x3 (3cc)/VAMP 75in (190cm); T460241A: (3cc)/VAMP Plus 69in (175cm); T530219D: x2 (3cc)/VAMP Plus 65in (165cm) | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | Class II | Open, Classified | |
| Z-0413-2024 | TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm),PXMK2041: (3 cc), PXMK2321: (3cc)/48in (122cm), PXMK2331: x4 (3cc)/12 in (30cm), PXMK9146: x 2 (3cc), PXMK1876: x3(3cc), PXVK1099:(3cc)/62in (157cm), PXMK0102: x2 (3cc)/84in (213cm), PXMK2043:X3(3CC), T001657A: x2 (3cc)/210cm, T001658A: x2 (3cc)/180 cm, T001660A: X3 (3CC)/150CM, T001709A: X2 (3 cc)/210 cm,T001767A: (3cc)/60in (150cm), T321573A: (3cc)/66 in (165cm), T433803A (3cc)/200cm, T441T01C: (3cc)/225 cm, T494C00B: (3 cc)/180 cm, | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | Class II | Open, Classified | |
| Z-0412-2024 | FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring. | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | Class II | Open, Classified | |
| Z-0411-2024 | FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring. | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | Class II | Open, Classified | |
| Z-0410-2024 | Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring. | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | Class II | Open, Classified | |
| Z-0409-2024 | Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring. | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | Class II | Open, Classified | |
| Z-0238-2024 | Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 | Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). | Class II | Open, Classified | |
| Z-2479-2023 | PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS | Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation. | Class II | Open, Classified | |
| Z-1380-2023 | Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm) | There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message. | Class II | Open, Classified | |
| Z-1379-2023 | Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm) | There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message. | Class II | Open, Classified | |
| Z-0147-2023 | Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. | Class II | Open, Classified | |
| Z-0146-2023 | Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. | Class II | Open, Classified | |
| Z-0835-2022 | FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment | Class II | Open, Classified | |
| Z-0834-2022 | FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA. | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment | Class II | Open, Classified | |
| Z-2283-2021 | Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US | There is a potential for internal leaks within catheters. | Class II | Terminated | |
| Z-2282-2021 | Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556 | There is a potential for internal leaks within catheters. | Class II | Terminated | |
| Z-2281-2021 | Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US | There is a potential for internal leaks within catheters. | Class II | Terminated | |
| Z-2280-2021 | Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US | There is a potential for internal leaks within catheters. | Class II | Terminated |
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