FDA Alerts Patients to Impella Heart Pump Device Recall After Reported Death
Patients with Impella therapy should talk to their doctors about whether this recall affects their care.
By
Lana Pine
| Published on August 27, 2025
2 min read
Credit: Adobe Stock/Ngampol
Abiomed is recalling certain Automated Impella Controllers (AICs) because of a part inside the device that may fail. These controllers are used to run the Impella heart pump, which helps the heart rest and recover by supporting blood flow.
The recall comes just weeks after a similar alert was announced for certain AICs because the device wasn’t connecting properly to the Impella heart pumps. Soon after, it was classified as a Class I recall and three deaths were linked to the issue.
Why is this happening?
Some controllers were built with the wrong type of electrical component (capacitor). If this part fails, the pump could suddenly stop or not work properly. This could cause loss of blood flow support, serious complications, and, in rare cases, death. So far, one patient death has been reported, but no serious injuries.
What patients need to know
- If you or a loved one is currently supported by an Impella pump, your care team should already be checking for affected controllers.
- Hospitals and clinics have been told not to use the affected controllers and to replace them with safe versions.
- The recall is aimed at health care providers, not individual patients — but it’s important to be aware if you are receiving or may need Impella therapy.
What you can do
- Ask your doctor whether this recall affects you, especially if you are on or scheduled for Impella support.
- If you experience sudden alarms such as “Impella Failure” or “Impella Stopped. Controller Failure,” your care team will switch you to a backup controller immediately.
- Patients and families can report any problems to the FDA MedWatch program.
For more information, contact:
- Abiomed Field Service: 1-800-422-8666 (option 3) or email ra-abm-fieldaction@its.jnj.com
- More details: FDA Recall Notice (updates will be posted as reviewed)
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