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