Home / Recalls / Medical Devices
Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Recalled January 14, 2026 · FDA recall Z-1030-2026 · Abiomed
Hazard
Device packaged in incorrect outer box carton. · FDA Class II
Units
6 units
Sold at
International distribution to the country of Australia and Taiwan.
Description
Device packaged in incorrect outer box carton.
Product
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →