Endologix AFX Introducer System Recalled for Dilator Breakage

Plain-English summary

Endologix, Inc. has initiated a voluntary recall of 53 units of the AFX Introducer System, Model Number S17-45. The recall covers specific lot numbers: 1079840, 1079843, 1079844, and 1079845. The AFX Introducer System is a medical device intended to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

The recall was initiated due to reports of dilator breakage during clinical procedures. The affected units were distributed worldwide, including nationwide in the United States (specifically in NY, NH, IN, MI, FL, and NJ) and in Europe and Latin America.

Healthcare providers and facilities should stop using the affected lots immediately and contact Endologix, Inc. for instructions on returning the devices. Patients who have had procedures using these specific devices should consult their healthcare provider if they have concerns.

The recalled product

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 b

Manufacturer

Endologix Inc

Category

Medical Device — Vascular Access

Hazard

• device-breakage

Affected units

53

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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