Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
This recall has been terminated (originally issued March 22, 2006).
- Company
- Endologix Inc
- Recall Initiated
- December 14, 2005
- Posted
- March 22, 2006
- Terminated
- March 22, 2012
- Recall Number
- Z-0589-06
- Quantity
- 9 (8 already used and 1 currently in distribution)
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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.
Distribution
For units still in distribution: AZ, DE, KS, PA, & TN
Lot / Code Info
Lot # W05-0884
Root Cause
Other
Action Taken
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.
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