Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998.
This recall has been terminated (originally issued January 11, 2010).
- Company
- Endologix Inc
- Recall Initiated
- November 25, 2009
- Posted
- January 11, 2010
- Terminated
- May 7, 2010
- Recall Number
- Z-0593-2010
- Quantity
- 3 UNITS DISTRIBUTED: 1 LOT W09-2966, 2 LOT W09-2998
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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 c
Distribution
Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.
Lot / Code Info
MODEL NUMBER 34-34-80L, LOTS W09-2966 AND W09-2998.
Root Cause
Process design
Action Taken
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.