Abiomed, Inc.: Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Abiomed, Inc.
- Product
- Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Reason / hazard
- Device packaged in incorrect outer box carton.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- International distribution to the country of Australia and Taiwan.
- Recall initiated
- 2025-12-04
- Code info
- 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;
- Product quantity
- 6 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Danvers
- State
- MA
- Country
- United States
- Event id
- 98086
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