FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: 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
- Recall number
- Z-2382-2010
- Recalling firm
- Abiomed, Inc.
- Product
- 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
- Status
- Terminated
- Initiated
- 2010-07-05
- Posted
- 2010-09-07
- Terminated
- 2010-09-10
- Reason
- Pump may separate at the motor housing while device is explanted
- Root cause
- Process control
- Action
- 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.
- Quantity
- 10 units
- Distribution
- International only: Canada and France
- Lot, serial or model codes
- Serial numbers: 45921,45922,45923,45924
- 510(k) numbers
- ["K083111"]
- PMA numbers
- not on file
- Product code
- KFM
- Firm FEI
- 1220648
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28