On May 13, 2013, Endologix, Inc. initiated a recall of AFX Introducer System Model S17-45 due to reports of the dilator breaking during procedures. Now this recall has been elevated to FDA Class I status.
Background
The AFX Introducer System is intended to help introduce catheters and other medical devices into blood vessels during procedures, with minimal blood loss.
This product was recalled due to reports of the dilator breaking during procedures. According to the recall notice, use of this product may cause serious adverse health consequences, including death.
The recalled product was distributed and manufactured from April 1, 2013 through April 30, 2013 and distributed in the U.S. only in Florida, Indiana, Michigan, New Hampshire, New Jersey and New York.
Affected lot numbers include 1079840, 1079843, 1079844, 1079845.
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.
The FDA recall notice can be found here.
Source: FDA