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Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
FDA product code QNR · Class 2 · Cardiovascular
31
Registered devices
386
Adverse events
2
Recalls
8
510(k) clearances
Devices with this code
TandemLung LifeSPARC — CARDIACASSIST, INC.LifeSPARC — CARDIACASSIST, INC.LifeSPARC — CARDIACASSIST, INC.LifeSPARC — CARDIACASSIST, INC.VitalFlow Power Cord NEMA-5-15, 3m — MICHIGAN CRITICAL CARE CONSULTANTS, INC.LifeSPARC — CARDIACASSIST, INC.TandemLife LifeSPARC — CARDIACASSIST, INC.VitalFlow Motor Drive — MICHIGAN CRITICAL CARE CONSULTANTS, INC.LifeSPARC — CARDIACASSIST, INC.LifeSPARC — CARDIACASSIST, INC.LifeSPARC — CARDIACASSIST, INC.VitalFlow Console — MICHIGAN CRITICAL CARE CONSULTANTS, INC.LifeSPARC — CARDIACASSIST, INC.LifeSPARC — CARDIACASSIST, INC.LifeSPARC — CARDIACASSIST, INC.VitalFlow Power Cord CEE 7/7, 2.5m — MICHIGAN CRITICAL CARE CONSULTANTS, INC.LifeSPARC — CARDIACASSIST, INC.VitalFlow Power Cord 12 V DC, 3m — MICHIGAN CRITICAL CARE CONSULTANTS, INC.TandemLife LifeSPARC — CARDIACASSIST, INC.TandemLife LifeSPARC — CARDIACASSIST, INC.VitalFlow Emergency Handcrank — MICHIGAN CRITICAL CARE CONSULTANTS, INC.LifeSPARC — CARDIACASSIST, INC.TandemLung LifeSPARC — CARDIACASSIST, INC.TandemLung LifeSPARC — CARDIACASSIST, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-10 | Thoratec LLC | 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 lo |
| 2025-10-03 | Medtronic Perfusion Systems | 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 to |
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