Blood Pump For Ecmo, Long-term (> 6 Hours) Use
Cardiovascular · 21 CFR 870.4100
A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
Recent MDR events
386 adverse event reports on file
- CentriMag Motor, USJul 29, 2026MalfunctionThoratec Switzerland Gmbh2916596-2026-2918560
- CENTRIMAG MOTOR, USJul 22, 2026MalfunctionThoratec Switzerland Gmbh3003306248-2026-00249
- CENTRIMAG MOTOR, OUSJul 13, 2026MalfunctionThoratec Switzerland Gmbh3003306248-2026-00244
- VITALFLOW CONSOLEJun 21, 2026InjuryMc3 Inc.3011468686-2026-00041
- VITALFLOW FLOW AND BUBBLE SENSOR, 2MJun 21, 2026InjuryMc3 Inc.3011468686-2026-00043
- CENTRIMAG MOTOR, USJun 19, 2026MalfunctionThoratec Switzerland Gmbh3003306248-2026-00236
- VITALFLOW CONSOLEJun 17, 2026MalfunctionMc3 Inc.3011468686-2026-00040
- CENTRIMAG MOTOR, USJun 11, 2026MalfunctionThoratec Switzerland Gmbh3003306248-2026-00220
- CENTRIMAG BLOOD PUMPJun 11, 2026MalfunctionThoratec Corporation3003306248-2026-00221
- CENTRIMAG BLOOD PUMPJun 7, 2026InjuryThoratec Switzerland Gmbh3003306248-2026-00200
Event type breakdown
Recalls
2 recall events for this product code
- Thoratec LLCOpen, ClassifiedJan 15, 2026
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016;
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.
Z-1099-2026 · View FDA record ↗ - Medtronic Perfusion SystemsOpen, ClassifiedNov 14, 2025
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.
Z-0509-2026 · View FDA record ↗
Registered firms
16 firms currently registered for this product code
Mc3, Inc.
Dexter, MI, US
Thoratec Corp
BURLINGTON, MA, US
Thoratec Corp.
PLEASANTON, CA, US
Sterigenics Eo Canada, Inc.
Mississauga Ontario, CA
Thoratec Switzerland Gmbh
ZURICH, CH
Plexus Manufacturing Sdn. Bhd.
Bayan Lepas Pulau Pinang, MY
Medtronic Mexico S. De R.l. De Cv
Tijuana Baja California, MX
Applimed Sa -cssr
Châtel St Denis Fribourg, CH
Minnetronix, Inc.
Saint Paul, MN, US
510(k) clearances
8 clearances for this product code
- Medtronic, Inc.May 20, 2025
K250199 · VitalFlow Console
- ABBOTT MEDICALJan 26, 2024
K234118 · CentriMag Acute Circulatory Support System
- Cardiacassist, Inc.Jan 19, 2024
K233736 · LifeSPARC System
- Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)Aug 25, 2023
K230364 · VitalFlow Console
- Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)Aug 25, 2023
K223898 · VitalFlowTM Centrifugal Pump
- Abbott (Formerly Thoratec Corporation)Dec 8, 2022
K222038 · CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System
- Cardiacassist, Inc.Nov 15, 2022
K211830 · LifeSPARC System
- Cardiacassist, Inc.Mar 26, 2021
K202751 · TandemHeart Pump and Escort Controller