FDA Medical Device Recalls (openFDA)
Endologix Inc: Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
- Recall number
- Z-0592-06
- Recalling firm
- Endologix Inc
- Product
- Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
- Status
- Terminated
- Initiated
- 2005-12-14
- Posted
- 2006-03-22
- Terminated
- 2012-03-22
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 28 (25 already used and 3 currently in distribution)
- Distribution
- For units still in distribution: AZ, DE, KS, PA, & TN
- Lot, serial or model codes
- Lot# W05-0514 & W05-0969
- 510(k) numbers
- not on file
- PMA numbers
- ["P040002"]
- 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