Product Safety Recalls

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W. L. Gore & Associates Inc. Recall 88331

Description: 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

W. L. Gore & Associates Inc. Recall 88331 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2340-2021
Event ID88331
Event DescriptionGore 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
Product TypeDevices
DistributionWorldwide 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.
Quantity3,364 units
Recall ReasonComplaints 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.
Device Classification20210901
Device Code InfoSerial Numbers between 22982051 - 23516741
Center Classification Date20210825
Recall Initiation Date20210712
Recalling FirmW. L. Gore & Associates Inc.
Initial Notification Letter
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