Recall Z-0594-2010 ยท OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Endologix Inc
Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
| Date | Jan 11, 2010 (initiated Nov 25, 2009) |
| Status | Terminated |
| Reason | This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health |
| Root cause | Process design |
| Action | The recall communication was initiated on 11/25/09 by phone call and followed by recall letter via Fed-Ex Overnight. The recall letter informed the consignees of the reason for recall and products affected. Users were instructed to share this information with physicians that performed the affected procedures at their facility. Endologix informed their consignees that their personnel would retrieve the affected devices and return it to Endologix at no cost and would replace the affected units. Consignees with questions or comments about the notice are directed to (800) 983-2284. |
| Quantity | 14 UNITS DISTRIBUTED: 3 LOT W09-2967 AND 1 LOT W09-3000 STILL AT CONSIGNEES. 10 UNITS USED. |
| Distribution | Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.