Recall Z-0491-03 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp
Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108
| Date | Jan 30, 2003 (initiated Dec 16, 2002) |
| Status | Terminated |
| Reason | The product is mislabeled, in that the LVAD Pneumatic Lead 5' is identified with a BLUE Collar (instead of Red) in order to distinguish RVAD. |
| Root cause | Other |
| Action | On 12/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices. |
| Quantity | 45 units |
| Distribution | The unit containing the affected product was shipped to a total of 25 hospitals in IL, PA, NY, TX, WI, FL, IN, WA, OK, AL, and WA-DC. The recall was appropriately extended to the consumer/user level; i.e., the hospitals, which received the recalled product. There is no known U. S. Government accou |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.