Impella 5.5 With Smartassist S2, Impella 5.5 With Smartassist S2 Set, Au.
Recall Summary Abiomed is recalling the Impella 5.5 with SmartAssist S2 and related sets because some devices were packaged in incorrect outer box cartons. This is a Class III recall affecting the product distribution. The recall applies to devices that may have been distributed with improper packaging.
- Recalling firm
- Abiomed, Inc.
- Product
- Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Reason
- Device packaged in incorrect outer box carton.
- Classification
- Class III
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-12-04
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/286b3024-e7d9-4221-9d3e-2d123a6f18dc