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
Medline Recalls Angiographic RA Control Syringes
Angiographic Syringe Recall: Medline Removes RA Control Syringes Due to Risk of Disconnection and Air Embolism The U.S. Food and Drug Administration (FDA) has announced that Medline Industries has issued an Urgent Medical Device Recall involving certain Namic...
FDA Class I Recall for Abiomed Impella Gen 1 Purge Cassettes
Medical Device Alert: Abiomed Impella Purge Cassette Recall (Class I) Abiomed has initiated a Class I recall, the most serious classification issued by the U.S. Food and Drug Administration, for certain Impella purge cassettes and associated pump sets due to a...
Class I Correction for Abiomed Impella Inaccurate Flow Readings
Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings Abiomed has issued an Urgent Medical Device Correction for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist systems due to potential inaccuracies in displayed pump performance...