FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000
- Recall number
- Z-1222-03
- Recalling firm
- Abiomed, Inc.
- Product
- BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000
- Status
- Terminated
- Initiated
- 2003-08-19
- Posted
- 2003-09-11
- Terminated
- 2003-10-15
- Reason
- Bi-Ventricular support system may switch to battery when primary voltage (AC) is available
- Root cause
- Other
- Action
- Abiomed notified customers by letter on 8/19/03 advising users of the problem and requesting that the unit not be used until a field service representative corrected the device.
- Quantity
- 36
- Distribution
- Nationwide. CA, DE, IL, IN, KY, FL, LA, MD, ND, NJ, NY, OR, WI, TX
- Lot, serial or model codes
- Serial Numbers: 3042, 3045-3047, 3049-3080.
- 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