Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL
This recall has been terminated (originally issued December 27, 2006).
- Company
- Endologix Inc
- Recall Initiated
- November 8, 2006
- Posted
- December 27, 2006
- Terminated
- November 4, 2011
- Recall Number
- Z-0310-2007
- Quantity
- 19
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide, including USA and Germany.
Lot / Code Info
Lot Numbers: W06-0079, W06-0334, W06-0393, W06-0501, W06-0658, W06-0773, W06-0988 & W06-1196
Root Cause
Other
Action Taken
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.
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