Z-1436-2013Class I

Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845

Name: Z-1436-2013 Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845
Creator: Endologix Inc
Published: 2013-05-13
License: https://open.fda.gov/license/

Endologix LLC / initiated 2013-05-13 / Terminated / root cause: manufacturing process

FDA source

Endologix Inc began a recall of Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended... on 2013-05-13. FDA classified it as Class I and gives the reason as "Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1436-2013
Classification: Class I
Status: Terminated
Initiated: 2013-05-13
Posted: 2013-06-07
Terminated: 2013-08-19
Recalling firm: Endologix LLC
Product: 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 code: DYB Introducer, Catheter
Reason for recall: Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Endologix Inc sent an "URGENT-MEDICAL DEVICE RECALL NOTICE" letters dated May 13, 2013 to all affected customers. The letter identified the affected product, reason for recall, and actions to be taken. The letter instructed customers to do not use or further distribute any affected product. The letter instructed customers to share this information with physicians that perform these procedures at the facility. The firm will call to confirm that this device is located at the facility. After confirmation the firm will retrieve the device. For questions call (800) 983-2284.
Quantity in commerce: 53
Distribution: Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.
Product codes and lots: Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1436-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1436-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-07

Product code DYB

K120212Class IIAfx Introducer SystemEndologix, Inc. / cleared 2012-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)