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Terminated

Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL

FDA Recall Z-0595-06 · Posted 2006-03-22

Recalling FirmEndologix Inc
Recall StatusTerminated
Product CodeMIH
Date Initiated2005-12-14
Date Terminated2012-03-22
Product Quantity29 (26 already used and 3 currently in distribution)

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.

Firm 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.

Root Cause

Other

Distribution Pattern

For units still in distribution: AZ, DE, KS, PA, & TN

Official Source

View FDA Recall →

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

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