Z-1222-03

BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000

Name: Z-1222-03 BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000
Creator: Abiomed, Inc.
Published: 2003-08-19
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2003-08-19 / Terminated

FDA source

Abiomed, Inc. began a recall of BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000 on 2003-08-19. The reason FDA records is "Bi-Ventricular support system may switch to battery when primary voltage (AC) is available". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1222-03
Status: Terminated
Initiated: 2003-08-19
Posted: 2003-09-11
Terminated: 2003-10-15
Recalling firm: Abiomed, Inc.
Product: BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Bi-Ventricular support system may switch to battery when primary voltage (AC) is available
FDA 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 in commerce: 36
Distribution: Nationwide. CA, DE, IL, IN, KY, FL, LA, MD, ND, NJ, NY, OR, WI, TX
Product codes and lots: Serial Numbers: 3042, 3045-3047, 3049-3080.

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)