Endologix, Inc., AFX Introducer System
Recall Class: Class I
Date Recall Initiated: May 13, 2013
Product: AFX Introducer System
- Model Number S17-45
- Lot Numbers: 1079840, 1079843, 1079844, 1079845
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.
Use: The AFX Introducer System is intended to help introduce catheters and other medical devices into blood vessels during procedures with minimal blood loss.
Irvine, California 92618
Reason for Recall: This product was recalled due to reports of the dilator breaking during procedures. Use of this recalled product may cause serious adverse health consequences, including death.
Public Contact: Customers may contact the firm at 1-800-938-2284.
FDA District: Los Angeles District Office
On May 13, 2013, the firm 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.
The firm will call each customer to confirm that this device is located at their facility. After confirmation, the firm will retrieve the device. For questions, call 1-800-983-2284.
On May 21 the firm expanded the recall by mailing a recall notification letter to an additional customer.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.