Brand Name: AFX" Introducer System — Class I medical device recall Z-1436-2013
Terminated recall by Endologix Inc, reported 2013-06-19, distributed nationwide. Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator b
| Recall number | Z-1436-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endologix Inc, Irvine, CA, United States |
| Recall initiated | 2013-05-13 |
| Classified | 2013-06-07 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2013-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 53 |
| Reason classes | device malfunction |
| Lot numbers | 1079840, 1079843, 1079844, 1079845 |
| Model numbers | S17-45 |
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.
Reason for recall
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1436-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.