Device to Dilate Blood Vessels Recalled Due to Risk of Breaking During Procedures

The AFX Introducer System was recalled due to reports of the dilator breaking during procedures. Use of this recalled product may cause serious adverse health consequences, including death. The model number is S17-45. Lot numbers: 1079840, 1079843, 1079844, 1079845.


The AFX Introducer System is intended to help introduce catheters and other medical devices into blood vessels during procedures with minimal blood loss. This 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.


On May 13, 2013, Endologix, Inc. of Irvine, California, sent its customers an urgent medical device recall notice letter. The letter included the product description, the reason for the recall, and actions to be taken. The firm’s instructions stated, "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. On May 21 the firm expanded the recall by mailing a recall notification letter to an additional customer.


The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.


See the Recall