Recall Z-1030-2026
Abiomed, Inc. · initiated December 4, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
Codes / lots: 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;
Reason for recall
Device packaged in incorrect outer box carton.
FDA-determined cause: Under Investigation by firm
Action taken
The consignee was sent a RECALL notice dated 12/4/25. The consignee is instructed to identify the two affected pumps in their inventory, quarantine them, and return the units to Abiomed, Danvers. The consignee is to complete and return the provided business reply form to their local Abiomed representative.
Details
- Recall number
- Z-1030-2026
- Initiated
- December 4, 2025
- Posted by FDA
- January 8, 2026
- Product code
- OZD – Temporary Non-Roller Type Left Heart Support Blood Pump
- Quantity
- 6 units
- Distribution
- International distribution to the country of Australia and Taiwan.
- Recalling firm
- Abiomed, Inc., Danvers, MA