Recall Z-1222-03 ยท DSQ Ventricular (Assist) Bypass
Abiomed, Inc.
BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000
| Date | Sep 11, 2003 (initiated Aug 19, 2003) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.