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Endologix Inc. AFX Introducer System: Class 1 Recall - Reports of Dilator Breaking During Procedures



6/18/2013 10:04:14 AM

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AUDIENCE: Risk Manager, Health Professional

ISSUE: 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.

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 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.

RECOMMENDATION: On May 13, 2013, 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. On May 21 the firm expanded the recall by mailing a recall notification letter to an additional customer. Customers may contact the firm with questions at 1-800-983-2284.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm357563.htm

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