FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.
- Recall number
- Z-0824-2010
- Recalling firm
- Abiomed, Inc.
- Product
- Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.
- Status
- Terminated
- Initiated
- 2009-12-16
- Posted
- 2010-03-04
- Terminated
- 2014-07-02
- Reason
- Console shut down with no audible alarm
- Root cause
- Process control
- Action
- Abiomed initiated the recall by telephone contact and followed with a Recall Letter dated January 27, 2010. Consignees were informed that a Field Service Engineer will be in contact and schedule a time to visit and correct the affected device. For further information, contact Abiomed Quality Assurance at 1-978-656-1543 or Abiomed Field Service at 1-800-554-8666.
- Quantity
- 496 units
- Distribution
- Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.
- Lot, serial or model codes
- Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.
- 510(k) numbers
- not on file
- PMA numbers
- ["P900023"]
- 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