{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194755", "product_res_number": "Z-1483-2022", "event_date_initiated": "2022-06-24", "event_date_created": "2022-08-01", "recall_status": "Open, Classified", "res_event_number": "90552", "product_code": "LOX", "pma_numbers": [ "P790017S081" ], "product_description": "Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.", "code_info": "GTIN/UPN 00643169850491, Lot Number: 222066656\nExpiration Date: 04/13/2023", "firm_fei_number": "3001504994", "recalling_firm": "Medtronic Inc", "address_1": "710 Medtronic Pkwy Mailstop Ls245", "city": "Minneapolis", "state": "MN", "postal_code": "55432-5603", "additional_info_contact": "Krystin Hayward\n763-514-4000", "reason_for_recall": "Luer has balloon diameter printed as \"2.25mmx12mm\" instead of the correct diameter, \"2.5mmx12mm\" as reflected on the product outer packaging.", "root_cause_description": "Labeling Change Control", "action": "The firm issued a recall notice on 06/24/2022 by US Mail.\nInstruction to Customers: 1. Identify and quarantine all unused affected products. \n2. Return all unused affected products in your inventory to Medtronic for replacement product or destroy all unused affected products in your inventory at your location. To initiate a product return contact Medtronic Customer Service at 800-854-3570. You local Medtronic Representative can assist you as necessary in initiating the return of this product.\n3. Complete the enclosed Customer Confirmation Form and email it to rs.cfqfca@medtronic.com.\n4. Consignees are asked to forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed.", "product_quantity": "84 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K123473", "K113464", "K121222", "K162434", "K160961", "K113220", "K220629", "K230374", "K133852", "K896108", "K110133", "K261759", "K143480", "K162625", "K180921", "K843944", "K162209", "K152485", "K103808", "K141025", "K233505", "K223189", "K861847", "K141933", "K122178", "K131169", "K210012", "K143160", "K112735", "K103095", "K182699", "K173680", "K200269", "K163114", "K223022", "K163660", "K252116", "K111284", "K121196", "K222538", "K110617", "K252295", "K192344", "K131450", "K141236", "K180040", "K160823", "K172264", "K111544", "K820410", "K211807", "K153742", "K110134", "K141090", "K123279", "K160985", "K163174", "K211349", "K103657", "K163200", "K163372", "K211393", "K173581", "K153682", "K170941", "K203390", "K134031", "K130391", "K254022", "K103110", "K133633", "K150292", "K202578", "K233729", "K121681", "K242969", "K123264", "K220634", "K121667", "K202619", "K230705", "K233499", "K103153", "K261428", "K181023", "K113775", "K251970", "K212393" ], "pma_number": [ "P850021", "P860019", "P890048", "P960014", "P890001", "P880027", "P020037", "P880065", "P890032", "P950020", "P970052", "P940009", "P870021", "P810046", "P880003", "P880055", "P870036", "P910031", "P840040", "P790017", "P930012", "P990008" ], "registration_number": [ "3013341368", "3016678045", "3013546453", "3024893679", "3015910259", "3034695832", "3009018440", "3007836437", "3043534762", "2024168", "1721686", "3007156625", "3012167431", "1028232", "3030236028", "3004415014", "3018805824", "3015002281", "2939561", "3004824117", "9617601", "3009613036", "3044156918", "3019807891", "3010273872", "2124215", "1225687", "9681260", "2183744", "3014222368", "3008573567", "3013634084", "3002807315", "9710284", "3003084171", "8010026", "3013152301", "3010391265", "1313046", "3008700817", "3008824097", "3006513822", "3048102902", "1422634", "1319639", "3004091615", "3013944123", "3009564766", "3014390222", "3006946276", "3009965866", "3008002401", "3031550970", "2134812", "9612164", "3035111606", "3003775186", "3012050423", "3009205152", "3011564431", "3010131137", "3003898360", "2011171", "3015453963", "3010220595", "3017262662", "9681834", "3030421123", "1000121056", "3002807314", "3006550224", "3014461810", "2134265", "3011137372", "3010432890", "3014656749", "8043892", "3017961114", "3012693555", "9614654" ], "fei_number": [ "3013341368", "3016678045", "3013546453", "1000138054", "3024893679", "3015910259", "3002827704", "3034695832", "3009018440", "3007836437", "3043534762", "2828", "3002808050", "2024168", "3004635528", "1721686", "3012167431", "1028232", "3008133910", "3030236028", "3004415014", "3018805824", "3015002281", "3002095335", "3004824117", "3009613036", "3002808904", "3044156918", "3019807891", "3010273872", "3003182398", "2124215", "2183744", "3014222368", "3008573567", "3005747797", "3013634084", "3002807315", "3002808327", "3003084171", "3013152301", "3010391265", "1313046", "3001451463", "3008700817", "3008824097", "3006513822", "3048102902", "1000514656", "3004091615", "3013944123", "3009564766", "3014390222", "3006946276", "3009965866", "3008002401", "3031550970", "3002806565", "3035111606", "3003775186", "3012050423", "3009205152", "3011564431", "3010131137", "3003898360", "2011171", "3002534070", "3015453963", "3010220595", "3017262662", "3030421123", "1000121056", "3002807314", "3006550224", "3014461810", "3010432890", "3014656749", "3017961114", "3012693555", "3002806434" ], "device_name": "Catheters, Transluminal Coronary Angioplasty, Percutaneous", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5100", "device_class": "2" } } ] }