FDA Alert: Abiomed Impella Blood Pump Urgent Recall
Controller may fail to detect the Impella deviceAbiomed Impella blood pump controllers
Controller May Fail to Detect Device
Abiomed has issued an urgent safety notice for its Automated Impella Controller (AIC) due to a potentially serious issue where the system may fail to detect the Impella blood pump when connected.
This malfunction could result in inadequate cardiac support, which is especially dangerous for patients in cardiogenic shock.
Affected Products, Product Codes, UDI-DIs, and Serial Numbers (click on the link to download a list.)
Key Details
- Issue: The controller may not recognize the connected pump during startup or transfer between consoles.
- No visual alarm appears on screen to indicate a problem.
- Reported Cases: 3 patient deaths have been linked to this issue as of June 13; no serious injuries reported.
- Impacted Devices: All AICs across the Abiomed Impella pump line.
Recommended Actions
- Always have a backup AIC available.
- If the pump isn’t detected within 20 seconds:
- Switch back to the previous console.
- Reboot the non-responsive console.
- Start the case on a different AIC if needed.
- Distribute this alert to all relevant clinical staff and facilities.
- Forward notice to any facility that received affected products.
Why It Matters
Failure to detect the pump could lead to delayed or absent hemodynamic support, putting critically ill patients at high risk.
For questions or to report adverse events, contact Abiomed at (978) 646-1400.
The FDA is actively reviewing this high-risk issue and will provide updates here as more information becomes available.
Read more about Mechanical Circulatory Support (MCS) devices
Study Reveals Delays in Medical Device Adverse Event Reporting
Healthcare professionals and the device industry share responsibility for timely adverse event reportingLapses defeat the purpose of adverse event reporting A recent study published in the British Medical Journal has spotlighted a troubling trend: many medical device...
A QSR to QMSR Transition Strategy
QMSR Implementation Strategy for U.S. Medical Device Manufacturers Not in Compliance with ISO 14385:2016 Transitioning from the FDA’s Quality System Regulation (QSR; 21 CFR 820) to the Quality Management System Regulation (QMSR) is a significant undertaking that...
QSR-to-QMSR Paper Gap Audit
Is Your Quality Management System Ready for QMSR? As FDA’s transition from the QSR to the QMSR approaches, many medical device manufacturers are discovering that “substantially equivalent” doesn’t mean “completely aligned.” Even companies with solid QSR documentation...