Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-
FDA device recall Z-0594-06 · posted 2006-03-22 · Terminated
Recall details
- Recalling firm
- Endologix Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIH
- Quantity affected
- 32 (24 already used and 8 currently in distribution)
- Distribution
- For units still in distribution: AZ, DE, KS, PA, & TN
- Date initiated
- 2005-12-14
- Date posted
- 2006-03-22
- Date terminated
- 2012-03-22
- Location
- Irvine, CA
Monitor recalls programmatically
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