Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
FDA adverse event reports and recall history for blood pump for ecmo, long-term (> 6 hours) use (product code QNR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 384
- Deaths
- 10
- Injuries
- 74
- Malfunctions
- 300
Reports per year
Source: FDA adverse event reports by year received, 2021–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-01-15Open, ClassifiedProcess design
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
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.
- 2025-11-14Open, ClassifiedSoftware in the Use Environment
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.
Monitor blood pump for ecmo, long-term (> 6 hours) use automatically
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