Recall Z-0496-2009 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp
Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139. Product is manufactured and distributed by Thoratec Corporation, Pleasant, CA. The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to cardiac transplan
| Date | Dec 22, 2008 (initiated Oct 24, 2008) |
| Status | Terminated |
| Reason | The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the HeartMate II Left Ventricular Assist System (HM II LVAS) blood pump with external system controller may result in damage that has the potential to interrupt pump function and may require a reoperation to replace the pump. |
| Root cause | Device Design |
| Action | An initial "Urgent: Medical Device Correction" letter dated October 21, 2008 and a follow-up letter dated October 24, 2008 were sent to affected HeartMate II Left Ventricular Assist System (HM II LVAS) customers. The letters identified the problem, immediate action and preventive action to be taken by customers and recommended that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. If customers suspect that a HM II LVAS patient may have a damaged percutaneous lead, please contact Thoratec Technical Services (800-456-1477) for assistance. A return re |
| Quantity | 2,335 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.