FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart.
- Recall number
- Z-2304-2008
- Recalling firm
- Abiomed, Inc.
- Product
- Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart.
- Status
- Terminated
- Initiated
- 2008-06-13
- Posted
- 2008-09-20
- Terminated
- 2008-10-08
- Reason
- Subassembly incorrectly aligned
- Root cause
- Process control
- Action
- Abiomed notified consignee by letter and on site visit on 5/13/08. The unit was removed and replaced.
- Quantity
- 1 unit
- Distribution
- NJ
- Lot, serial or model codes
- Serial Number: 1028043
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LOZ
- 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