Recall Z-0412-2007 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp
Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
| Date | Feb 10, 2007 (initiated Sep 24, 2004) |
| Status | Terminated |
| Reason | The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON. |
| Root cause | Other |
| Action | The firm issued on 1/25/07 an URGENT: MEDICAL DEVICE CORRECTION-notice informing its consignees about the 'Power Switch Replacement Instructions' and arrangements for their service department replacement of the switches. |
| Quantity | 331 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.