Heart Pump Recall: Abiomed Removes Impella Cp Sets With Smartassist
Recall Summary Abiomed is recalling certain Impella CP heart pump sets because they don't meet manufacturing specifications and may have low purge pressure from the start of use. The affected products are specific Impella CP Sets equipped with SmartAssist technology. This recall applies to heart pump sets distributed by Abiomed for use in cardiac support procedures.
- Recalling firm
- Heart Pump
- Reason
- Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-MEDWATCH-RSS
- Recall date
- 2026-07-02
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/83a54247-d8e1-4530-b2cf-ace2c6562be6