Endologix, Inc. AFX Introducer System: Class I Recall
MedSun: Newsletter #86, July 2013
FDA MedWatch Safety Alert
Recall of AFX Introducer System Model S17-45 due to reports of the dilator breaking during procedures. On May 13, 2013, Endologix sent its customers an Urgent Medical Device Recall Notice letter stating "Do not use or further distribute any affected product.” The firm also instructed their customers to share this information with physicians who perform these procedures at their facilities.
Endologix, Inc. AFX Introducer System: Class I Recall. FDA MedWatch Safety Alert. June 18, 2013.