October 23, 2018

FDA: Class I recall of Endologix AFX Endovascular AAA System

By: Judy Mathias
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Editor's Note

The Food & Drug Administration on October 15 classified the recall by Endologix, Inc, of its AFX Endovascular AAA System as Class I, the most serious.

The recall was initiated because of the risk of Type III endoleaks. When a Type III endoleak occurs, blood continues to flow into the aneurysm, increasing the likelihood of serious injury, rupture, or death.

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