FDA MedWatch Safety AlertsUnited States24 September 2026
Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers
This is an official announcement record
Firsthand records what FDA MedWatch Safety Alerts announced and links to the original. The wording below is theirs, not ours.
Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.
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Opens www.fda.gov
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