Reported Feb 12, 2020 · Terminated

GORE¿ EXCLUDER¿ AAA Endoprosthesis

W. L. Gore & Associates Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: W. L. Gore & Associates Inc. · 32360 N North Valley Pkwy · Phoenix, AZ · 85085-4228

Is this the product you have?

  • GORE¿ EXCLUDER¿ AAA Endoprosthesis
Lot codes and dates

135 of 135 products

Products covered by this recall
#Product as published
1Catalog numbers PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB* *= size Table 1: Device Configurations for Trunk-Ipsilateral Leg Component: RLT231212X*
2RLT231214X*
3RLT231216X*
4RLT231218X*
5RLT231412X*
6RLT231414X*
7RLT231416X*
8RLT231418X*
9RLT261212X*
10RLT261214X*
11RLT261216X*
12RLT261218X*
13RLT261412X*
14RLT261414X*, RLT261416X*
15RLT261418X*
16RLT281212X*
17RLT281214X*
18RLT281216X*
19RLT281218X*
20RLT281412X*
Amount recalled
255861 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

Firm has received reports of leading end catheter component separations.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 9, 2022 · Data as of Sep 19, 6:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.