ClearanceBrief
Recall Z-2340-2021 ยท MJN Catheter, Intravascular Occluding, Temporary

W. L. Gore & Associates Inc.

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

DateJul 12, 2021
StatusOpen, Classified
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.
Root causeProcess change control
ActionOn July 23, 2021 issue a "Urgent Medical Device Recall" notification to affected consignees via UPS. In addition to informing consignees about the recall the customer notification ask consignees to take the following actions: 1. Identify and return any unused devices within the scope of this voluntary recall. 2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to WLGore4731@stericycle.com within 2 weeks of receipt of this notification. 3. Please share this letter with others in your hospital or clinic as appropriate. 4. If a listed device has been used, there is no
Quantity3,364 units
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, DE
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K172567GORE Molding and Occlusion Balloon Catheter
W. L. Gore and Associates, Inc., Jan 31, 2018