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U.S. Department of Health and Human Services

Class 2 Device Recall Gore Molding & Occlusion Balloon Catheter

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 Class 2 Device Recall Gore Molding & Occlusion Balloon Cathetersee related information
Date Initiated by FirmJuly 12, 2021
Create DateAugust 25, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2340-2021
Recall Event ID 88331
510(K)NumberK172567 
Product Classification Catheter, intravascular occluding, temporary - Product Code MJN
ProductGore 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
Code Information Serial Numbers between 22982051 - 23516741
Recalling Firm/
Manufacturer		 W. L. Gore & Associates Inc.
32360 N North Valley Pkwy
Phoenix AZ 85085-4228
For Additional Information ContactMPD Customer Care
800-528-8763
Manufacturer 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.
FDA Determined
Cause 2		Process 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 patient-follow up needed and there are no further actions needed other than informing Gore the device was used. Please indicate the used devices on the CUSTOMER RESPONSE FORM and return to WLGore4731@stericycle.com within 2 weeks of receipt of this letter. No further action is needed.
Quantity in Commerce3,364 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, DEU, DNK, ESP, FIN, FRA, GBR, GRC, HRV, HUN, IRL, ISR, ITA, JPN, MEX, NLD, NOR, POL, PRT, SMR, SWE.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MJN
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