Monthly Prescribing Reference

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

The US Food and Drug Administration has identified this as a Class I recall, with continued device use resulting in serious injury or death. Endologix has issued a device recall for the AFX ...
TCTMD

FDA: All AFX Endovascular AAA Systems Now Under Class I Recall

The US Food and Drug Administration (FDA) has issued a MedWatch recall notice for all AFX Endovascular AAA Systems by Endologix following a voluntary recall action by the company in July. The notice, ...
WCPO Cincinnati

Abdominal Aortic Aneurysm Repair Devices Recalled Due To High Rate of Failure

The FDA continues to investigate and urgently warn about the dangers posed by certain medical devices manufactured by Endologix Inc., specifically the AFX Endovascular AAA System. These devices are ...
BioWorld

Endologix exits challenging month, resumes shipment of some AFX devices

Endologix Inc. has resumed shipping of some of its AFX endovascular abdominal aortic aneurysm systems, after placing the devices on hold. This brought an end to a rather tumultuous week for the Irvine ...
Insider Monkey

Endologix, Inc. (ELGX) Updates Physicians Concerning Stent Graft Treatment Devices

Following discussions with the Food and Drug Administration, Endologix, Inc. (NASDAQ:ELGX) has issued updating information to physicians concerning the AFX Endovascular AAA System. The letter ...
Medscape

Endologix Broadens Recall to All AFX Endovascular AAA Systems

Endologix is recalling all of its AFX endovascular abdominal aortic aneurysm (AAA) systems after continued reports of type III endoleaks. The US Food and Drug Administration (FDA) has identified this ...
Healio

FDA reiterates importance of yearly, lifelong follow-up for Endologix AAA grafts

The FDA issued a safety communication to remind patients and health care providers of the importance of at least yearly, lifelong follow-up for patients with Endologix AFX endovascular grafts, to ...
TCTMD

FDA: New Concerns Surface With Endologix Grafts for AAA

(UPDATED) The US Food and Drug Administration today issued a safety communication to physicians and patients regarding Endologix AFX endovascular grafts following new concerns. Those concerns, notes ...
BioWorld

FDA advisory panel sees a role for Endologix AFX devices despite FDA’s safety concerns

The FDA convened a Nov. 2 advisory panel to review the data for the AFX2 by Endologix LLC, of Irvine, Calif., with some indication that the agency believes the data suggest a poor benefit-risk ratio ...
Business Wire

FDA Classifies Previous Endologix AFX Safety Notice as Class I Recall

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 ...
Business Wire

Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA System

IRVINE, Calif.--(BUSINESS WIRE)--Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives with innovative interventional treatments for vascular disease, ...
News Medical

Previous Endologix AFX Safety Notice classified by FDA as Class I recall

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) ...