Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
FDA device recall Z-1030-2026 · posted 2026-01-08 · Open, Classified
Recall details
- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Device packaged in incorrect outer box carton.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OZD
- Quantity affected
- 6 units
- Distribution
- International distribution to the country of Australia and Taiwan.
- Date initiated
- 2025-12-04
- Date posted
- 2026-01-08
- Location
- Danvers, MA
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