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Recall of endovascular AAA system designated as Class 1
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The FDA has designated Endologix’ product recall of an endovascular abdominal aortic aneurysm system as a Class 1 recall, the most serious kind. The recall affects 61,300 devices manufactured and distributed since March 2011.
The recall was made due to reports of type IIIa and IIIb endoleaks of the system (AFX Endovascular AAA Systems, Endologix), which is used to prevent rupture in patients with abdominal aortic aneurysm, according to a MedWatch report from the FDA.
Most of the reported endoleaks relate to devices made with a specific graft material (Strata) that has not been used in their manufacture since July 2014. Health care providers were advised to remove remaining systems with the graft material in December 2016. The system with a substitute graft material (Duraply) and an additional system (AFX2, Endologix) have been distributed since then, though it is unclear whether they have resulted in fewer endoleaks or if they have not been placed in patients long enough to result in leaks, according to the report.
The company sent a letter to physicians on July 20, 2018, informing them of the reported leaks, recommendations and updated instructions for patient safety. Physicians were also instructed to continue follow-up of patients who were treated with the system and to report any adverse reactions or quality problems to MedWatch.