FDA Medical Device Recalls (openFDA)
Endologix Inc: Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998.
- Recall number
- Z-0593-2010
- Recalling firm
- Endologix Inc
- Product
- Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998.
- Status
- Terminated
- Initiated
- 2009-11-25
- Posted
- 2010-01-11
- Terminated
- 2010-05-07
- Reason
- This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health c
- Root cause
- Process design
- Action
- The recall communication was initiated on 11/25/09 by phone call and followed by recall letter via Fed-Ex Overnight. The recall letter informed the consignees of the reason for recall and products affected. Users were instructed to share this information with physicians that performed the affected procedures at their facility. Endologix informed their consignees that their personnel would retrieve the affected devices and return it to Endologix at no cost and would replace the affected units. Consignees with questions or comments about the notice are directed to (800) 983-2284.
- Quantity
- 3 UNITS DISTRIBUTED: 1 LOT W09-2966, 2 LOT W09-2998
- Distribution
- Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.
- Lot, serial or model codes
- MODEL NUMBER 34-34-80L, LOTS W09-2966 AND W09-2998.
- 510(k) numbers
- not on file
- PMA numbers
- ["P040042"]
- Product code
- OAD
- 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