FDA Classifies Previous Endologix AFX Safety Notice as Class I Recall
ENDOLOGIX (ELGX)
Last endologix earnings: 2/19 04:01 pm
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US:NASDAQ Investor Relations:
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Source: Business Wire
IRVINE, Calif.--(BUSINESS WIRE)-- Endologix® Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received notice that the U.S. Food and Drug Administration (FDA) has classified a voluntary recall action that Endologix took in July of this year as a Class I recall. The July recall involved Endologix’s issuance of a Safety Notice to healthcare professionals (HCPs) using the AFX® Endovascular AAA System. The Safety Notice, dated 20 July 2018, provided updated information on comparative AFX Type III endoleak rates, patient-tailored surveillance recommendations, and recommendations for intervening through an AFX device or re-intervening on an AFX device. No product was removed from the field as part of this recall. The July 2018 Safety Notice followed several earlier communications. Safety Notices from Endologix issued in late 2016 a
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