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AFX Endovascular AAA System, Endoleak Type IIIA recallZ-1037-2017 · Endologix · initiated Dec 27, 2016

Class II Terminated All recalls posted in January 2017

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Endologix or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

FDA root cause category: Device Design

What the company is doing

Endologix sent a dear physician letter dated June 2, 2015, to inform them of the enclosed 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). The letter informs the Physicians of the year's update on the clinical programs and commercial experience (i.e. post-market surveillance). A dear physician letter dated January 2016 was seen to inform them of the enclosed 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and commercial experience (i.e. post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of the devices. A dear physician letter dated December 27, 2016, will be sent to provide important information related to the AFX Endovascular AAA System (AFX System). Endologix is informing the customers of a series of updates to the Instructions for Use (IFU) and modifications to the product. Customers with any questions are instructed to contact their local Endologix representative.

Recall details

Recall number
Z-1037-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 27, 2016
Posted by the FDA
Jan 18, 2017
Recalling firm
Endologix
Product code
MIH
FDA submissions
P040002
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Product description

AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Code information (models, lots, serial numbers)

The correction is not lot specific. It applies to AFX procedures conducted after July 2015

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.

Sources and updates

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