medical Class II Updated 2021-09-01

W. L. Gore & Associates Inc. recalls Gore Molding & Occlusion Balloon Catheter, REF Catalogue Num

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers between 22982051 - 23516741
View official government recall

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