Endologix Inc: Medical Device Recall in 2013 - (Recall #: Z-1436-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

Product Classification:

Class I

Date Initiated: May 13, 2013

Date Posted: June 19, 2013

Recall Number: Z-1436-2013

Event ID: 65248

Reason for Recall:

Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.

Status: Terminated

Product Quantity: 53

Code Information:

Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845

Distribution Pattern:

Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.

Voluntary or Mandated:

Voluntary: Firm initiated