Recall Z-0015-2007 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp
Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
| Date | Oct 4, 2006 (initiated Jan 26, 2004) |
| Status | Terminated |
| Reason | During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism. |
| Root cause | Other |
| Action | On 1/26/2004, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall. |
| Quantity | 11 units |
| Distribution | Nationwide to 11(eleven) hospitals. The product was shipped within the United States in IL, MA, NC, MD, MO, FL, CA, AZ, PA, and NY. The product was distributed to one consignee in Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.