Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-
FDA device recall Z-0309-2007 · posted 2006-12-27 · Terminated
Recall details
- Recalling firm
- Endologix Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIH
- Quantity affected
- 11
- Distribution
- Worldwide, including USA and Germany.
- Date initiated
- 2006-11-08
- Date posted
- 2006-12-27
- Date terminated
- 2011-11-04
- Location
- Irvine, CA
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