Abiomed, Inc.

Frequent Recalls

5

Recalls

0

Units Recalled

0

Injuries

0

Deaths

1 category · 2026-03-11 to 2026-04-08

Date	Source	Product	Brand	Severity	Units
2026-04-08	FDA Device	FDA Recall: Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1	Abiomed, Inc.	Class I	N/A
2026-04-08	FDA Device	FDA Recall: Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in	Abiomed, Inc.	Class I	N/A
2026-03-11	FDA Device	FDA Recall: Impella RP Flex with SmartAssist. Product Code: 1000323.	Abiomed, Inc.	Class I	N/A
2026-03-11	FDA Device	FDA Recall: Impella RP with SmartAssist. Product Code: 0046-0035.	Abiomed, Inc.	Class I	N/A
2026-03-11	FDA Device	FDA Recall: Impella RP. Product Code: 0046-0011.	Abiomed, Inc.	Class I	N/A