Recall Z-1030-2026— Abiomed, Inc.

Name: FDA recall Z-1030-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-04

Class II · Ongoing

Class II FDA medical device recall by Abiomed, Inc., initiated 2025-12-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.. Reason: Device packaged in incorrect outer box carton..

Recalling firm: Abiomed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-04
Firm location: Danvers, MA, United States

Product description

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

Reason for recall

Device packaged in incorrect outer box carton.

Data sourced from openFDA. This site is unofficial and independent of the FDA.