Z-0595-06

Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model...

Name: Z-0595-06 Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model...
Creator: Endologix Inc
Published: 2005-12-14
License: https://open.fda.gov/license/

Endologix LLC / initiated 2005-12-14 / Terminated

FDA source

Endologix Inc began a recall of Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL on 2005-12-14. The reason FDA records is "The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0595-06
Status: Terminated
Initiated: 2005-12-14
Posted: 2006-03-22
Terminated: 2012-03-22
Recalling firm: Endologix LLC
Product: Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
FDA root cause: Other
Action: The three affected hospitals were contacted telephone and in writing (Recall Letters) sent via FedEx Endologix field personnel are scheduled to remove the product units by 12/16/05. Notices for Phase II of recall to 8 additional consignees for 6 additional models (9 lots) being recalled mailed 12/19-12/22/05.
Quantity in commerce: 29 (26 already used and 3 currently in distribution)
Distribution: For units still in distribution: AZ, DE, KS, PA, & TN
Product codes and lots: W05-0513 & W05-883

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)