The FDA has issued an early alert regarding a significant safety concern with Abiomed’s Automated Impella Controllers. Clinical, quality, and regulatory teams should carefully review this information to ensure patient safety and compliance with medical device regulations. The alert focuses on specific issues with the purge retainer fixation within the devices, which may result in critical functionality failures.
What Changed?
Abiomed has identified and communicated a potential defect in certain Automated Impella Controllers. The issue involves failures in the purge retainer fixture, such as cracking, which can lead to purge pressure complications. These complications may cause errors, alarms, and even interruptions in hemodynamic support. Abiomed has highlighted that if the purge retainer failure leads to a pump stop, it could result in a loss of hemodynamic support, posing a severe risk to patient health, including the possibility of permanent injury or death.
The FDA is proactively monitoring the situation and will provide updates as new information becomes available. Abiomed has reported five serious injuries and no fatalities linked to this issue as of August 27, 2025.
Who Is Affected?
The alert applies to specific models of Automated Impella Controllers with the following product codes and UDI-DI identifiers:
- Product Code: 0042-0000-US, Description: Impella Controller, Packaged, US, UDI-DI: 00813502010022
- Product Code: 0042-0010-US, Description: Impella Optical Controller, Packaged, US, UDI-DI: 00813502010985
- Product Code: 0042-0040-US, Description: Optical, AIC, Impella Connect, Packaged, US, UDI-DI: 00813502011401
- Product Code: 1000432, Description: AIC with Impella Connect for ECP, UDI-DI: 00813502013030
- Product Code: 1000201, Description: Double Optical, AIC Impella Connect, Packaged, US, UDI-DI: 00813502010442
A full list of affected products is available on the official FDA website.
What Actions Should Be Taken?
Abiomed has outlined steps for affected facilities to mitigate risks:
- Hospital inventory may continue to be used while awaiting service.
- Abiomed will collect and update the affected devices through servicing at its service center.
- Upon contact by the Abiomed field servicing team, customers should cooperate to return identified devices for updates.
- Forward Abiomed’s notification to relevant personnel within your facility, including those managing, storing, or using these devices.
- If products have been forwarded to another facility, ensure the notice reaches them.
- Fill out and return the provided business response form as instructed.
It is crucial to report any adverse reactions or quality issues to the FDA’s MedWatch system via the online portal or by mail and fax.
How Are the Devices Used?
The Automated Impella Controller serves as the primary user interface for Impella Catheters. These devices are designed to alleviate the workload on the heart’s left ventricle and support the circulatory system, enabling the heart to recover. Critical functionality disruptions, as identified in this alert, underscore the life-sustaining role these devices play.
Conclusion
Abiomed has taken steps to address the purge retainer issue in Automated Impella Controllers, working with customers to implement device updates. Healthcare professionals must remain vigilant, follow the recommended actions, and ensure proper communication within their facilities. Continued monitoring of the FDA’s updates is essential as the situation evolves.
Disclaimer
The information provided in this post is for informational purposes only and does not constitute legal or regulatory advice. Healthcare professionals and organizations should rely on their regulatory teams for compliance-related decisions.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-automated-impella-controller-purge-retainer-fixation-issue-abiomed