{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "188406", "product_res_number": "Z-2340-2021", "event_date_initiated": "2021-07-12", "event_date_created": "2021-08-25", "recall_status": "Open, Classified", "res_event_number": "88331", "product_code": "MJN", "k_numbers": [ "K172567" ], "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", "code_info": "Serial Numbers between 22982051 - 23516741", "firm_fei_number": "3007284313", "recalling_firm": "W. L. Gore & Associates Inc.", "address_1": "32360 N North Valley Pkwy", "city": "Phoenix", "state": "AZ", "postal_code": "85085-4228", "additional_info_contact": "MPD Customer Care\n800-528-8763", "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.", "root_cause_description": "Process change control", "action": "On 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: \n\n1. Identify and return any unused devices within the scope of this voluntary recall.\n\n2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to\nWLGore4731@stericycle.com within 2 weeks of receipt of this\nnotification.\n\n3. Please share this letter with others in your hospital or clinic as appropriate.\n\n4. If a listed device has been used, there is no patient-follow up needed and there are no\nfurther actions needed other than informing Gore the device was used. Please indicate\nthe used devices on the CUSTOMER RESPONSE FORM and return to WLGore4731@stericycle.com within 2 weeks of receipt of this letter. No further\naction is needed.", "product_quantity": "3,364 units", "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.", "openfda": { "k_number": [ "K152762", "K221294", "K112219", "K080700", "K191606", "K201652", "K041306", "K212324", "K983802", "K001917", "K003320", "K011656", "K090970", "K052844", "K132990", "K011535", "K182916", "K011526", "K143613", "K090728", "K131869", "K103780", "K080861", "K110741", "K121785", "K152833", "K053440", "K955499", "K051137", "K960422", "K964390", "K093847", "K093911", "K214060", "K990487", "K110903", "K143454", "K172790", "K021210", "K210358", "K972777", "K070770", "K183679", "K001237", "K023914", "K243795", "K192786", "K051067", "K960832", "K960715", "K103356", "K140273", "K092495", "K091504", "K002286", "K031357", "K170411", "K203540", "K101570", "K021066", "K993292", "K992942", "K160067", "K062220", "K122576", "K211610", "K193440", "K210602", "K251358", "K993248", "K180904", "K183045", "K172567", "K100063", "K081454", "K071367", "K142692", "K915869", "K160598", "K200459", "K043023", "K091458", "K132022", "K141175", "K113698", "K033159", "K153530", "K001621", "K994141", "K010162" ], "registration_number": [ "3013944123", "3010079067", "3009766315", "1220948", "3018565086", "1018233", "2029386", "3008837339", "2183744", "1318694", "3016842760", "9681260", "3002807314", "2032112", "3007113487", "3016257349", "3008816935", "3005994106", "3012279212", "1319639", "1048735", "1928237", "1724474", "2528981", "3016704395", "9616684", "1721676", "1424778", "3007284006", "2124215", "3012159165", "3032916632", "3007284313", "3008114965", "3008853977", "3000126629", "2648045", "3010432890", "8023054", "3004859241", "3006082230", "1000121056", "3012497308", "3012179728", "3011660785", "3045042524", "2135147", "3008881809", "3007628272", "3013556777", "2029214", "3010173425", "9618000", "3015138222", "3011279674", "3009756153", "3015550451", "2011171", "3026788751", "2183982", "3005255160", "3008627763", "3014162263" ], "fei_number": [ "3013944123", "3010079067", "1000306647", "1000138054", "3009766315", "3018565086", "1220948", "1018233", "3008837339", "2183744", "1318694", "3016842760", "3003094851", "3002807314", "1000220862", "3007113487", "3016257349", "3005334138", "3005994106", "3012279212", "3003245778", "1048735", "1928237", "2528981", "3016704395", "1000116168", "3004216185", "1721676", "3007284006", "3032916632", "2124215", "3012159165", "3007284313", "3008114965", "3009438986", "3008853977", "3002807036", "3003473227", "3000126629", "2648045", "3010432890", "3002806565", "3004859241", "3006082230", "1000121056", "3012497308", "3012179728", "3011660785", "3002913962", "3045042524", "3008881809", "3003076831", "3007628272", "3013556777", "3015138222", "3011279674", "3009756153", "3015550451", "2011171", "3026788751", "3005255160", "3008627763", "3014162263" ], "device_name": "Catheter, Intravascular Occluding, Temporary", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4450", "device_class": "2" } } ] }