Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
FDA product code QNR · Class II (moderate risk) · 21 CFR 870.4100 · Cardiovascular
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.
8510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250199 | VitalFlow ConsoleQNR · Traditional | Medtronic, Inc. | 05/20/2025SE |
| K234118 | CentriMag Acute Circulatory Support SystemQNR · Special | Abbott Medical | 01/26/2024SE |
| K233736 | LifeSPARC SystemQNR · Traditional | Cardiacassist, Inc. | 01/19/2024SE |
| K230364 | VitalFlow ConsoleQNR · Traditional | Michigan Critical Care Consultants, Inc. (D.B.A… | 08/25/2023SE |
| K223898 | VitalFlowTM Centrifugal PumpQNR · Traditional | Michigan Critical Care Consultants, Inc. (D.B.A… | 08/25/2023SE |
| K222038 | CentriMag Blood Pump for use with CentriMag Acute Circulatory Support SystemQNR · Traditional | Abbott (Formerly Thoratec Corporation) | 12/08/2022SE |
| K211830 | LifeSPARC SystemQNR · Traditional | Cardiacassist, Inc. | 11/15/2022SE |
| K202751 | TandemHeart Pump and Escort ControllerQNR · Traditional | Cardiacassist, Inc. | 03/26/2021SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1099-2026 Class II | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE…Acute circulatory support system pump may not fit into the motor and reports received of the pump not being… | Thoratec LLC | 10/10/2025Open, Classified |
| Z-0509-2026 Class II | MC3 VitalFlow Console, REF 58100; Blood pump of ecmoAs of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error… | Medtronic Perfusion Systems | 10/03/2025Open, Classified |