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W. L. Gore & Associates Inc. recalls Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compat
Recalled September 1, 2021 · FDA recall Z-2340-2021 · W. L. Gore & Associates
Hazard
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. · FDA Class II
Units
3,364 units
Sold at
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AUS, CAN, CHE, DEU, DNK, ESP, FIN, FRA, GBR, GRC, HRV, HUN, IRL, ISR, ITA, JPN, MEX, NLD, NOR, POL, PRT, SMR, SWE.
Description
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.
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
Manufacturer(s)
W. L. Gore & Associates Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →