FDA Medical Device Recalls (openFDA)
Endologix Inc: Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL
- Recall number
- Z-0310-2007
- Recalling firm
- Endologix Inc
- Product
- Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL
- Status
- Terminated
- Initiated
- 2006-11-08
- Posted
- 2006-12-27
- Terminated
- 2011-11-04
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 19
- Distribution
- Worldwide, including USA and Germany.
- Lot, serial or model codes
- Lot Numbers: W06-0079, W06-0334, W06-0393, W06-0501, W06-0658, W06-0773, W06-0988 & W06-1196
- 510(k) numbers
- not on file
- PMA numbers
- ["P040042"]
- Product code
- MIH
- Firm FEI
- 1000125107
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28