Reported Sep 1, 2021 · Ongoing
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire…
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 Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797
- UDI(00)733132639489
- Lot codes and dates
- Serial Numbers between 22982051 - 23516741
- Amount recalled
- 3,364 units
Where it was sold
Why it was recalled
Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.
This product could cause temporary or reversible health problems — stop using it.
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