Brand Name: AFX" Introducer System, Model Number S17-45 recallZ-1436-2013 · Endologix Inc · initiated May 13, 2013
Class I Terminated All recalls posted in June 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Endologix Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1436-2013
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- May 13, 2013
- Posted by the FDA
- Jun 7, 2013
- Recalling firm
- Endologix Inc
- Quantity
- 53
- Product code
- DYB
- FDA submissions
- K120212
- 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 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.
Code information (models, lots, serial numbers)
Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845
Other devices under the same FDA submission
1 device cleared under K120212 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AFX Introducer System S17-45Endologix LLC · Introducer, Catheter2 deaths23 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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