Z-0594-2010

Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967...

Name: Z-0594-2010 Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967...
Creator: Endologix Inc
Published: 2009-11-25
License: https://open.fda.gov/license/

Endologix LLC / initiated 2009-11-25 / Terminated / root cause: manufacturing process

FDA source

Endologix Inc began a recall of Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000 on 2009-11-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0594-2010
Status: Terminated
Initiated: 2009-11-25
Posted: 2010-01-11
Terminated: 2010-05-07
Recalling firm: Endologix LLC
Product: Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
Product code: OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
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
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: MODEL NUMBER 34-34-80LE, LOTS W09-2967 AND W09-3000.

Product code OAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)