FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: AB5000 Console Circulatory Support System Catalog Number: 0015-0000
- Recall number
- Z-0574-2007
- Recalling firm
- Abiomed, Inc.
- Product
- AB5000 Console Circulatory Support System Catalog Number: 0015-0000
- Status
- Terminated
- Initiated
- 2007-01-08
- Posted
- 2007-03-07
- Terminated
- 2008-02-07
- Reason
- Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.
- Root cause
- Other
- Action
- Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
- Quantity
- 55 units
- Distribution
- Worldwide, including USA, Japan, Germany, Australia, and Mexico.
- Lot, serial or model codes
- Serial Numbers: 5261- 5317
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DSQ
- 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