Powerlink System for Abdominal Aortic Aneurysm (Endoluminal… recallZ-0592-06 · Endologix Inc · initiated Dec 14, 2005
Terminated All recalls posted in March 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
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0592-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 14, 2005
- Posted by the FDA
- Mar 22, 2006
- Recalling firm
- Endologix Inc
- Quantity
- 28 (25 already used and 3 currently in distribution)
- Product code
- MIH
- FDA submissions
- P040002
- Distribution
- For units still in distribution: AZ, DE, KS, PA, & TN
Product description
Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
Code information (models, lots, serial numbers)
Lot# W05-0514 & W05-0969
Other devices under the same FDA submission
97 devices cleared under P040002 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- AFX2 Bifurcated Endograft System BEA28-100/I20-40Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment4 deaths107 reports
- AFX2 Bifurcated Endograft System BEA28-90/I20-30Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths67 reports
- Vela Proximal Endograft System A28-28/C95-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment2 deaths66 reports
- AFX2 Bifurcated Endograft System BEA25-100/I16-40Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths62 reports
- AFX2 Bifurcated Endograft System BEA25-90/I16-30Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment1 death53 reports
- AFX Endovascular AAA System BA28-90/I20-30Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment1 death50 reports
- AFX2 Bifurcated Endograft System BEA28-100/I16-40Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths50 reports
- AFX2 Bifurcated Endograft System BEA25-100/I20-40Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths50 reports
- AFX2 Bifurcated Endograft System BEA22-90/I16-30Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment4 deaths48 reports
- AFX2 Bifurcated Endograft System BEA28-90/I16-30Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment7 deaths47 reports
- AFX2 Bifurcated Endograft System BEA28-120/I20-40Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths45 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 34219).
- Z-0589-06 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
- Z-0590-06 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
- Z-0591-06 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
- Z-0593-06 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
- Z-0594-06 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
- Z-0595-06 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
- Z-0596-06 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
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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