Recall Z-1030-2026 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
| Date | Jan 8, 2026 (initiated Dec 4, 2025) |
| Status | Open, Classified |
| Reason | Device packaged in incorrect outer box carton. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 6 units |
| Distribution | International distribution to the country of Australia and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.