← FDA ENFORCEMENT
Z-1030-2026Class II

Abiomed, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Abiomed, Inc.
Product type
Device
Status
Ongoing
Report date
2026-01-14
Distribution
International distribution to the country of Australia and Taiwan.
Firm state
MA
Product quantity
6 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Device packaged in incorrect outer box carton.

Product description

Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

Code / lot info

Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →