Class 1 Device Recall: Endologix AFX Device Recalled Due to Type III Endoleaks

The recall is due to continued reports of both Type IIIa and IIIb endoleaks.
The recall is due to continued reports of both Type IIIa and IIIb endoleaks.

Endologix has issued a device recall for the AFX Endovascular AAA System (AFX), used to treat abdominal aortic aneurysm. The US Food and Drug Administration (FDA) has identified this as a Class I recall, with continued device use resulting in serious injury or death.1,2

The recall is due to continued reports of both Type IIIa and IIIb endoleaks. According to the FDA, when left undetected and untreated, “a Type III endoleak may result in serious patient injury, such as an [abdominal aortic aneurysm] rupture or death.”

This recall is an update to a December 2016 safety update sent to physicians,3 which requested that all unused devices in hospital inventories be quarantined and returned to Endologix.

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The most recent safety update letter1 included new data on rates of Type III endoleaks and updated patient surveillance recommendations which suggest conducting “high-resolution CT scan imaging…at [1] month, [6] months, [1] year, and annually thereafter.”1

The FDA release notes that while this recall does apply to all AFX systems, endoleak reports have primarily been linked to the AFX with Strata graft material, which has not been manufactured since July 2014. It is unclear if the AFX with Duraply graft material and AFX2 devices — which have been manufactured for a shorter time — are overall less likely to have endoleaks or whether these devices have not been implanted long enough for endoleaks to occur.2

Patients who currently have implanted AFX devices should continue regular, lifelong treatment with their physician. Revised instructions for use are available upon request.

References

  1. Endologix, Inc. Urgent: Important Safety Update. Published July 20, 2018. Accessed October 15, 2018.
  2. Endologix, Inc. recalls AFX Endovascular AAA Systems due to risk of type III endoleaks [news release]. Silver Springs, MD: US Food and Drug Administration. Updated October 15, 2018. Accessed October 15, 2018.
  3. Endologix, Inc. Important Safety Update. Published December 30, 2016. Accessed October 15, 2018.