FDA Device recall Z-1436-2013
Brand Name: AFX" Introducer System, Model Number S17-45
- FDA Device
- Class I
- terminated
- Published 2013-06-19
On 2013-06-19 the FDA classified a Class I recall of Brand Name: AFX" Introducer System, Model Number S17-45 by Endologix, citing endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1436-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-05-13 |
| Published | 2013-06-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Endologix |
| Distribution | US |
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
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Identifiers
| code_info | Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1436-2013%22
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