Reported Feb 12, 2020 · Terminated
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
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¿ Iliac Branch Endoprosthesis (IBE)
- Lot codes and dates
- -Catalog numbers PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB* *= size -not specific to any particular lot or serial numbers. For full details of affected products see 806 Attachment 1 - Catalog Numbers and Sizes.
- Amount recalled
- 23212 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.
Want the full recall guide?
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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