Purge Cassette Recall: Abiomed Removes Impella Heart Pump Purge Cassettes

Abiomed is recalling Impella Generation 1 Purge Cassettes due to an increased risk of purge leaks that could cause the heart pump to lose pressure or stop working. The cassettes are components of the Impella heart pump system used in patients who need temporary heart support. The recall affects existing Impella Generation 1 Purge Cassettes in use.

Reason

Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops.

Category

medical device recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-04-03

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/007467aa-4861-4501-808c-7ff56d8bf555