FreshRecalls

Impella CP Set with SmartAssist: recall status

⚠ Recall found. Impella CP Set with SmartAssist is named in 1 official recall in our current data. Details and the official notices are below — act on the remedy in the official notice.

Brand
Abiomed

Recalls naming this model

FDA Class I · Medical device · June 24, 2026

Impella CP Set with SmartAssist recall — Abiomed, Inc.

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Official ID Z-2457-2026 · Official record ↗

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Compiled from official public-domain CPSC, NHTSA, and FDA data. Sources last checked July 24, 2026 at 1:09 AM UTC.