Endologix Infrarenal Bifurcated Powerlink System with… recallZ-0310-2007 · Endologix Inc · initiated Nov 8, 2006
Terminated All recalls posted in December 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Endologix Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0310-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 8, 2006
- Posted by the FDA
- Dec 27, 2006
- Recalling firm
- Endologix Inc
- Quantity
- 19
- Product code
- MIH
- FDA submissions
- P040042
- Distribution
- Worldwide, including USA and Germany.
Product description
Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL
Code information (models, lots, serial numbers)
Lot Numbers: W06-0079, W06-0334, W06-0393, W06-0501, W06-0658, W06-0773, W06-0988 & W06-1196
Other devices under the same FDA submission
3 devices cleared under P040042 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Safire™ TX 402840Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter8 reports
- Safire™ TX 402841Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- Therapy™ IBI-83371Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 36803).
- Z-0309-2007 · TerminatedEndologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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