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Terminated

Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL

FDA Recall Z-0310-2007 · Posted 2006-12-27

Recalling FirmEndologix Inc
Recall StatusTerminated
Product CodeMIH
Date Initiated2006-11-08
Date Terminated2011-11-04
Product Quantity19

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide, including USA and Germany.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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