Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998

FDA device recall Z-0593-2010 · posted 2010-01-11 · Terminated

Recall details

Recalling firm

Endologix Inc

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

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.

Root cause

Process design

Status

Terminated

Product code

OAD

Quantity affected

3 UNITS DISTRIBUTED: 1 LOT W09-2966, 2 LOT W09-2998

Distribution

Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.

Date initiated

2009-11-25

Date posted

2010-01-11

Date terminated

2010-05-07

Location

Irvine, CA