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
Global Medical Device Reporting and Vigilance
International Medical Device Reporting Medical Device Reporting and Vigilance in the EU and Globally Timely and transparent reporting of medical device incidents is critical to protecting public health and ensuring continued confidence in healthcare technologies....
Device Recall Alert: Edwards Lifesciences Arterial Cannula
Edwards Lifesciences Arterial CannulaSource: FDAEdwards Lifesciences Recalls Arterial Cannulae Over Risk of Exposed Wire Edwards Lifesciences has issued a Class I recall of certain arterial cannula devices due to the risk of wire exposure near the cannula tip, which...
Device Recall: ZOLL AutoPulse NXT Resuscitation System
Urgent Class I Medical Device Recall ZOLL Circulation, Inc. has issued a Class I recall of its AutoPulse NXT Resuscitation System (Model 200, Software Version 2.0.1) due to a system error that may cause the device to stop chest compressions or deliver compressions...