Home / Recalls / W. L. Gore & Associates Inc. / Z-2340-2021

Z-2340-2021 Class II Ongoing

Recalled by W. L. Gore & Associates Inc. — Phoenix, AZ

FDA device recall Z-2340-2021 was initiated by W. L. Gore & Associates Inc. on July 12, 2021 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 3,364 units.

Recall Details

Product Type: Devices
Report Date: September 1, 2021
Initiation Date: July 12, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,364 units

Product 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

Reason for Recall

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.

Distribution Pattern

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.

Code Information

Serial Numbers between 22982051 - 23516741