Early Alert: Heart Pump Issue From Abiomed
Abiomed Impella Device Recall Summary Certain Impella heart pump devices contain a differential pressure sensor that may malfunction and provide inaccurate readings. The sensor values can drift over time, which could affect how the device operates. This issue affects users of the affected Impella devices manufactured during the relevant period.
- Recalling firm
- Abiomed
- Product
- 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
- 2026-05-27
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/36fc499c-085d-4cc1-abfa-086d3c157254