Early Alert: Heart Pump Issue From Abiomed

Summary Abiomed is recalling certain Impella CP heart pump sets because they may not meet proper specifications and could develop low purge pressure problems from the start of use. The issue affects specific batches of this heart pump device. Patients and healthcare facilities using these particular sets are involved in this recall.

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/39679870-84c8-4ffe-a64c-392b042757f6