Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours
This recall has been terminated (originally issued September 7, 2010).
- Company
- Abiomed, Inc.
- Recall Initiated
- July 5, 2010
- Posted
- September 7, 2010
- Terminated
- September 10, 2010
- Recall Number
- Z-2382-2010
- Quantity
- 10 units
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Pump may separate at the motor housing while device is explanted
Distribution
International only: Canada and France
Lot / Code Info
Serial numbers: 45921,45922,45923,45924
Root Cause
Process control
Action Taken
ABIOMED issued the recall notification letter on July 5 , 2010 to the one affected customer (France) and requested that they segregate and return any unused pumps. The pumps in Canada were already used. If you have any questions, contact +49 241 8860-0 or e-mail europe@abiomed.com.
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