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AFX Endovascular AAA System, Endoleak Type IIIA recallZ-1035-2017 · 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 initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).

FDA root cause category: Other

What the company is doing

Endologix sent an Dear Physician letter dated June 2, 2015, were sent to customers to inform them that Endologix has enclosed the 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 customer letter includes update on the clinical programs and commercial experience (ie. post-market surveillance). On January 2016, Dear Physician letters were sent to customers to inform them that Endologix has enclosed the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and commercial experience (ie. 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. The customer letter includes updates on the Clinical Programs and Commercial experience. A Dear Physician letter, "Important Safety Update AFX Endovascular AAA System: Type III Endoleaks", was sent to provide important information related to the AFX Endovascular AAA System (AFX System). The letter informs the customers that Endologix has an active post-market surveillance program that has been monitoring and evaluating the performance of the AFX System since its introduction to the market in 2011. In January of 2013, Endologix conducted an investigation into reports of Type IIIa endoleaks (separation of bifurcated and extension stent grafts at the point of overlap), which was followed by an investigation into Type IIIb endoleaks (disruption of the stent graft material) in September of 2013. For further questions please call (949) 595-7200.

Recall details

Recall number
Z-1035-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 27, 2016
Posted by the FDA
Jan 18, 2017
Recalling firm
Endologix
Quantity
40,967
Product code
MIH
FDA submissions
P040002
Distribution
Worldwide Distribution - US Distribution and to the countries of : 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

Code information (models, lots, serial numbers)

The correction is not lot specific. It applies to AFX procedures conducted after June 2013

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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