Endologix, Inc. has issued a Class 1 recall for its AFX Introducer System. The AFX Introducer System is a medical device that helps physicians introduce catheters or other medical devices into a patient’s blood vessels during surgical procedures.
According to a warning issued by the Food and Drug Administration, Endologix recalled the AFX Introducer System after receiving reports in which the device’s dilator broke in the middle of a procedure. The FDA has warned that problems with the AFX Introducer during surgery could result in serious health complications, including death.
Endologix sent a warning letter to its customers on May 13, 2013 to alert them of the recall notice. The letter warned them to stop using the AFX Introducer System Model immediately and to share information about the product recall with doctors so that they will stop using the device.
Endologix stated in the recall notice that it will call all of its customers to confirm that the AFX Introducer System is being used at their facility. The company stated that it will also send a representative to customers who have confirmed that they have one of the recalled devices in order to retrieve the device. Customers with questions about the Endologix recall can call a phone number set up by the company at 1-800-983-2284.
The recalled AFX Introducer models were manufactured and distributed in April 2013. The devices were only distributed in a handful of US states: Florida, Indiana, Michigan, New Hampshire, New Jersey and New York. The recalled model number for the AFX Introducer System is S17-45. Three lot numbers were affected by the recall: 1079840, 1079843, 1079844, 1079845.
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