Recall Z-1109-2007 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp
Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.
| Date | Jul 27, 2007 (initiated Mar 30, 2007) |
| Status | Terminated |
| Reason | Incorrect collect nut assembly (inadvertent use of the incorrect (Black) collect nut) during surgical implantation (wrong size collect nut) to secure the inflow cannula to the PVAD has resulted in patient deaths |
| Root cause | Device Design |
| Action | The firm has issued an Urgent Medical Device Correction notice dated March 30, 2007, to all VAD customers alerting them to the hazard. The letter instructs them that a Thoratec representative will be contacting them to make arrangements to apply a warning label to the affected devices. The letter also informs them to dispose of any expired original design caged tip atrial cannula and to 1) not use the black collet and nut with any current design VAD, 2) make sure that all current patients using PVADs are using the appropriate collet nut, and 3) provide a copy of the product safety bulletin t |
| Quantity | 2,484 units |
| Distribution | Class I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.