Z-0309-2007

Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model...

Name: Z-0309-2007 Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model...
Creator: Endologix Inc
Published: 2006-11-08
License: https://open.fda.gov/license/

Endologix LLC / initiated 2006-11-08 / Terminated

FDA source

Endologix Inc began a recall of Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL on 2006-11-08. The reason FDA records is "Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0309-2007
Status: Terminated
Initiated: 2006-11-08
Posted: 2006-12-27
Terminated: 2011-11-04
Recalling firm: Endologix LLC
Product: Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.
FDA root cause: Other
Action: The affected hospitals were contacted telephone on 11/08/06 and in writing (Recall Letters) sent via FedEx 11/09/06. The firm also released a press statement on 11/10/06. All affected consignees have been contacted and instructed to return the specified products to Endologix.
Quantity in commerce: 11
Distribution: Worldwide, including USA and Germany.
Product codes and lots: Lot Numbers: W06-0333, W06-0392, W06-0500, W06-0553, W06-0621, W06-1100 & W06-1152

Product code MIH

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)