Early Alert: Heart Pump Controller Purge Cassette Issue From Abiomed

Abiomed is recalling Automated Impella Controllers because the purge cassette may not be recognized properly, which could delay the delivery of mechanical heart support to patients who need it. The issue affects heart pump controller purge cassettes used with these devices. This is an early alert notification of the removal from the market.

Recalling firm

Abiomed

Product

Heart Pump Controller Purge Cassette

Reason

Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.

Category

medical device recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-09-03

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/cc498747-d718-4a68-97c9-43af1905bfeb