AFX Introducer Recall Issued Due to Risk of Dilator Breaking During Use

Reports of dilators breaking during medical procedures has resulted in the recall of AFX Introducer Systems, which are used to help insert catheters and other medical devices into blood vessels.  

The FDA announced a Class I AFX Introducer System recall this week after reports of broken dilators. The class I designation means that the FDA believes that the use of this product could cause serious injury or death.

The manufacturer, Endologix, Inc., originally sent out an URGENT MEDICAL DEVICE RECALL NOTICE letter to customers on May 13. The letter urged customers not to use or further distribute the recalled system. The FDA did not indicate whether the reported incidents had resulted in serious injury or death for any patients.

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The recall affects the AFX Introducer System, model number S17-45, from lot numbers 1079840, 1079843, 1079844, and 1079845. The affected systems were distributed and manufactured from April 1, 2013 through April 30, 2013 and were distributed in Florida, Indiana, Michigan, New Hampshire, New Jersey and New York.

Endologix has instructed customers to share information about the recall with physicians who perform procedures using the AFC Introducer System a their facilities. The company said it plans to notify all affected customers by phone to confirm the device is present and to arrange for the recalled system’s return.

Customers with questions can call (800) 983-2284.

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