Terumo Cardiovascular Systems Corporation
Elkton, MD, US
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION appears in FDA device records in Elkton, MD. FDA records list 160 510(k) clearances between and , 50 PMA records and 3 registered establishments. As of , FDA records show 620 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Terumo Cardiovascular Systems Corporation 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.
- MicroVention, Inc.registration, 510(k), PMA, enforcement report, recall
- Terumo Cardiovascular Corporationrecall
510(k) clearance history
Showing 50 of 160FDA records hold 160 510(k) clearances for Terumo Cardiovascular Systems Corporation between 2000 and 2025. The busiest year on record is 2009, with 16. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 6 |
| 2002 | 10 |
| 2003 | 6 |
| 2004 | 4 |
| 2005 | 3 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 9 |
| 2009 | 16 |
| 2010 | 8 |
| 2011 | 10 |
| 2012 | 11 |
| 2013 | 10 |
| 2014 | 9 |
| 2015 | 16 |
| 2016 | 7 |
| 2017 | 4 |
| 2018 | 5 |
| 2019 | 3 |
| 2020 | 5 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) | JCX | Substantially Equivalent | |
| K232542 | Wedge XL Delivery Catheter | QJP | Substantially Equivalent | |
| K234065 | CDI OneView Monitoring System | DRY | Substantially Equivalent | |
| K230775 | SOFIA EX Intracranial Support Catheter | QJP | Substantially Equivalent | |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | NTE | Substantially Equivalent | |
| K221895 | Terumo Advanced Perfusion System 1 | DTQ | Substantially Equivalent | |
| K222115 | ISAAC Neurovascular Navigation Catheter | DQY | Substantially Equivalent | |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) | KRD | Substantially Equivalent | |
| K214024 | SOFIA 88 Catheter | DQY | Substantially Equivalent | |
| K211120 | ERIC Retrieval Device | NRY | Substantially Equivalent | |
| K200091 | Capiox iCP Centrifugal Pump | KFM | Substantially Equivalent | |
| K193607 | BOBBY Balloon Guide Catheter | DQY | Substantially Equivalent | |
| K201487 | Traxcess 7 Mini Guidewire | MOF | Substantially Equivalent | |
| K200547 | Traxcess 14 SELECT Guidewire | MOF | Substantially Equivalent | |
| K191680 | AZUR Vascular Plug | KRD | Substantially Equivalent | |
| K192684 | HydroPearl Microspheres | NOY | Substantially Equivalent | |
| K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) | DQY | Substantially Equivalent | |
| K182829 | Scepter Mini Occlusion Balloon Catheter | DQY | Substantially Equivalent | |
| K182602 | SOFIA EX Intracranial Support Catheter | DQY | Substantially Equivalent | |
| K182110 | CDI Blood Parameter Monitoring System 550 | DRY | Substantially Equivalent | |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) | DTZ | Substantially Equivalent | |
| K173200 | SOFIA Plus Aspiration Catheter | NRY | Substantially Equivalent | |
| K172014 | Wedge Microcatheter | DQY | Substantially Equivalent | |
| K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) | DTZ | Substantially Equivalent | |
| K172220 | Advanced Perfusion System 1 | DTQ | Substantially Equivalent | |
| K163531 | Advanced Perfusion System 1 | DTQ | Substantially Equivalent | |
| K162999 | V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System | HCG | Substantially Equivalent | |
| K162524 | AZUR CX Detachable 18 Peripheral Coil System | KRD | Substantially Equivalent | |
| K163154 | Traxcess 7 Mini XSoft Guidewire | MOF | Substantially Equivalent | |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 | DWB | Substantially Equivalent | |
| K161803 | Traxcess .007 Mini Guidewire | MOF | Substantially Equivalent | |
| K161452 | MicroPlex Coil System (MCS) - HyperSoft 3D | HCG | Substantially Equivalent | |
| K161367 | HydroCoil Embolic System (HES) | HCG | Substantially Equivalent | |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | GEI | Substantially Equivalent | |
| K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) | HCG | Substantially Equivalent | |
| K153053 | Traxcess Pro 14 Guidewire | MOF | Substantially Equivalent | |
| K150870 | HydroPearl Microspheres, HydroPearl Microspheres | KRD | Substantially Equivalent | |
| K153376 | Advanced Perfusion System 1 | DTQ | Substantially Equivalent | |
| K153213 | Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir | DTZ | Substantially Equivalent | |
| K153143 | Capiox Advance Hardshell Reservoir | DTN | Substantially Equivalent | |
| K153140 | Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating | DTZ | Substantially Equivalent | |
| K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir | DTZ | Substantially Equivalent | |
| K151389 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir | DTZ | Substantially Equivalent | |
| K151358 | AZUR CX Detachable 35 Coils | KRD | Substantially Equivalent | |
| K150958 | LifePearl Microshperes | KRD | Substantially Equivalent | |
| K151349 | Advanced Perfusion System 1 | DTQ | Substantially Equivalent | |
| K150536 | Terumo Circuit Tubing | DWF | Substantially Equivalent | |
| K150542 | Terumo Pump Tubing | DWE | Substantially Equivalent | |
| K150366 | SOFIA 6F Catheter | DQY | Substantially Equivalent | |
| K142449 | Headway 27 Microcatheter | DQY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013556777 | 3013556777 | MicroVention, Inc. | 35 Enterprise, Aliso Viejo, CA 92656 US | 2026 | and 13 more, listed in full below |
| 1124841 | 3000204839 | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | 125 BLUE BALL RD, ELKTON, MD 21921 US | 2026 | and 7 more, listed in full below |
| 1828100 | 1828100 | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | 6200 Jackson Road, ANN ARBOR, MI 48103 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
- NAJAgents, Embolic, For Treatment Of Uterine Fibroids
- DSJAlarm, Blood-Pressure
- CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- GFABlade, Saw, General & Plastic Surgery, Surgical
- OEZCardiovascular Procedure Kit
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- KRACatheter, Continuous Flush
- MJNCatheter, Intravascular Occluding, Temporary
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- QJPCatheter, Percutaneous, Neurovasculature
- NRYCatheter, Thrombus Retriever
- DSKComputer, Blood-Pressure
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- DWCController, Temperature, Cardiopulmonary Bypass
- MJJCpb Check Valve, Retrograde Flow, In-Line
- DTPDefoamer, Cardiopulmonary Bypass
- KRLDetector, Bubble, Cardiopulmonary Bypass
- HCGDevice, Neurovascular Embolization
- KRDDevice, Vascular, For Promoting Embolization
- DXJDisplay, Cathode-Ray Tube, Medical
- ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter
- SGFDural Arteriovenous Fistula Liquid Embolic
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- CAHFilter, Bacterial, Breathing-Circuit
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- DPWFlowmeter, Blood, Cardiovascular
- MOFGuide, Wire, Catheter, Neurovasculature
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DWSInstruments, Surgical, Cardiovascular
- OUTIntracranial Aneurysm Flow Diverter
- QCAIntracranial Coil-Assist Stent
- OPRIntrasaccular Flow Disruption Device
- GCJLaparoscope, General & Plastic Surgery
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
- BTAPump, Portable, Aspiration (Manual Or Powered)
- DTNReservoir, Blood, Cardiopulmonary Bypass
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- MWSStabilizer, Heart
- NIMStent, Carotid
- FMFSyringe, Piston
- NTETemporary Carotid Catheter For Embolic Capture
- DRSTransducer, Blood-Pressure, Extravascular
- BYYTube, Aspirating, Flexible, Connecting
- BYXTubing, Pressure And Accessories
- DWETubing, Pump, Cardiopulmonary Bypass
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 620| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2912-2026 | BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. | Due to an increase rate of balloon pinhole defects. | Class II | Open, Classified | |
| Z-2200-2026 | LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm | Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events | Class II | Open, Classified | |
| Z-0108-2026 | Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE, FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X | Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences. | Class II | Open, Classified | |
| Z-2188-2025 | LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400 | Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient. | Class II | Open, Classified | |
| Z-2018-2025 | CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit | Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response. | Class II | Open, Classified | |
| Z-1492-2025 | Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 | During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value. | Class II | Open, Classified | |
| Z-1121-2025 | MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms. | Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer. | Class II | Open, Classified | |
| Z-0990-2025 | Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846 | Sterility assurance; microcatheter inner packaging may contain incomplete seal. | Class II | Open, Classified | |
| Z-3157-2024 | ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vasculature in patients suffering from acute ischemic stroke. | Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date. | Class II | Open, Classified | |
| Z-1401-2024 | Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534 75607 75765 75797 75833 75903 75956 75973 76131 76178 76278 76306 76398 76427 76498 76519 76536 76565 76575 76628 76630 76635 76644 76687 76725 76775 76789 76832 76839 76878 76900 76999 77010 77014 77015 77105 77227 77299 77304 77305 77412 77450 77496 77516 77629 77722 77742 77757 77791 77794 77796 78018 78027 165720 205307A 65046-03 65080-06 65167-06 65934-01 65940-01 66041-01 66154-01 66503-02 70148-02 70178-06 70188-05 70638-07 70664-02 70665-01 70734-03 71064-01 71432-02 71433-01 71546-02 71733-02 71754-04 71801-02 71820-01 71928-06 71934-04 72073-02 72149-01 72226-06 72326-07 73008-02 73346-01 73567-01 73568-01 73776-04 73783-02 73882-03 74172-03 74685-01 74734-01 74833-01 74879-07 74921-02 74965-03 74965-04 74972-01 75030-01 75050-02 75068-01 75159-01 75293-01 75409-01 75409-02 75410-01 75410-02 75540-03 75540-05 75572-01 75642-02 75688-01 75790-02 75834-01 75927-01 75959-01 75972-01 76178-01 76273-01 76278-01 76308-01 76326-02 76372-01 76373-01 76374-01 76376-01 76491-01 76732-02 76873-02 77012-02 77127-01 77316-01 77496-01 77502-01 77521-01 77532-01 77655-01 77791-01 B75409 B75410 B75903 B76178 B76278 | Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention | Class II | Open, Classified | |
| Z-0868-2024 | TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 | Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. | Class II | Open, Classified | |
| Z-0187-2024 | AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 | Peripheral coil system detachable has a potential of unsealed pouch packaging. | Class II | Open, Classified | |
| Z-2238-2023 | FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508, FRED4508-PMA, FRED4513-PMA, FRED4518-PMA, FRED4528, FRED4528-PMA, FRED4539, FRED4539-CA, FRED4539-PMA, FRED5009, FRED5009-PMA, FRED5014-PMA, FRED5019-PMA, FRED5029, FRED5029-CA, FRED5029-PMA, FRED5514-CA, FRED5514-PMA, FRED5526-CA, FRED5526-PMA, MV-F351127, MV-F352427, MV-F401227, MV-F401727, MV-F451327, MV-F500927, MV-F501427, MV-F501927, MV-F552627 | Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended. | Class II | Open, Classified | |
| Z-1347-2023 | CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC | Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port. | Class II | Open, Classified | |
| Z-1346-2023 | CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE | Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port. | Class II | Open, Classified | |
| Z-1345-2023 | CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 | Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port. | Class II | Open, Classified | |
| Z-0170-2023 | WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System. | Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels | Class II | Open, Classified | |
| Z-0949-2022 | Cardiovascular Procedure Kit catalog # 76645 & 73806 | Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping. | Class II | Terminated | |
| Z-0202-2022 | Aspiration Syringe Kit, REF: MVSK60 | Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers. | Class II | Terminated | |
| Z-2350-2021 | Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 | intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs | Class II | Terminated | |
| Z-1830-2021 | VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. | Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. | Class III | Terminated | |
| Z-1829-2021 | VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. | Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. | Class III | Terminated | |
| Z-1828-2021 | VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. | Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. | Class III | Terminated | |
| Z-1791-2021 | The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number: TCM II, with Cardioplegia, 110V/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia, 220V/50Hz (P/N 164935) TCM II, without Cardioplegia, 220V/50Hz (P/N 164940) TCM (P/N 15747) Catalog Number: 4415, 164925, 164930, 164935, 15747 | Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices. | Class II | Terminated | |
| Z-1790-2021 | The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Device Name / Model Number: TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940 | Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices. | Class II | Terminated |
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