Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
This recall is currently active, issued January 8, 2026. It was issued by Abiomed, Inc..
- Company
- Abiomed, Inc.
- Recall Initiated
- December 4, 2025
- Posted
- January 8, 2026
- Recall Number
- Z-1030-2026
- Quantity
- 2 units
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Device packaged in incorrect outer box carton.
Distribution
International distribution to the country of Australia.
Lot / Code Info
Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27.
Root 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.
More recalls by Abiomed, Inc.
Impella RP. Product Code: 0046-0011.
Feb 27, 2026