{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "188975", "product_res_number": "Z-2504-2021", "event_date_initiated": "2021-08-24", "event_date_created": "2021-09-22", "recall_status": "Open, Classified", "res_event_number": "88549", "product_code": "DRA", "k_numbers": [ "K834352" ], "product_description": "DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only", "code_info": "Model/Reference Number 12116, Lot Number (GTIN Number): 2018080039 (20643169086719), 2018091020 (20643169086719), 2018100911 (20643169086719), 2018111023 (20643169086719), 2018111419 (20643169086719), 2019120925 (20643169086719), 2018080039 (00673978462943), 2018091020 (00673978462943), 2018100911 (00673978462943), 2018111023 (00673978462943), 2018111419 (00673978462943), 2018120581 (20643169086719), 2018120581 (00673978462943), 2018120582 (20643169086719), 2018120582 (00673978462943), 2018121084 (20643169086719), 2018121084 (00673978462943), 2019010456 (20643169086719), 2019010456 (00673978462943), 2019010764 (20643169086719), 2019010764 (00673978462943), 2019020136 (20643169086719), 2019020136 (00673978462943), 2019020368 (20643169086719), 2019020368 (00673978462943), 2019020758 (20643169086719), 2019020758 (00673978462943), 2019030720 (20643169086719), 2019030720 (00673978462943), 2019031167 (20643169086719), 2019031167 (00673978462943), 2019040262 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(20643169086719), 2018111418 (20643169086719), 2018111420 (20643169086719), 2018121083 (20643169086719), 201901C047 (20643169086719), 201901C048 (20643169086719), 201901C049 (20643169086719), 2019020759 (20643169086719), 201902C156 (20643169086719), 2019051126 (20643169086719), 201905C012 (20643169086719), 2019060218 (20643169086719), 2019060423 (20643169086719), 2019060686 (20643169086719), 201906C175 (20643169086719), 2019070713 (20643169086719), 2019081001 (20643169086719), 2019081291 (20643169086719), 2019091156 (20643169086719), 2019091157 (20643169086719), 2019100416 (20643169086719), 2019100731 (20643169086719), 2019101094 (20643169086719), 2019101445 (20643169086719), 2019110083 (20643169086719), 2019120089 (20643169086719), 2019120926 (20643169086719), 2020010369 (20643169086719), 2020020093 (20643169086719), 2020020470 (20643169086719), 2020020471 (20643169086719), 2020020763 (20643169086719), 2020030850 (20643169086719), 2020031186 (20643169086719), 2020040402 (20643169086719), 2020040762 (20643169086719), 2020050352 (20643169086719), 2020050699 (20643169086719), 2020050918 (20643169086719), 2020060963 (20643169086719), 2020070653 (20643169086719), 2020070654 (20643169086719), 2020070967 (20643169086719), 2020070968 (20643169086719), 2020071272 (20643169086719), 2020080074 (20643169086719), 2020080408 (20643169086719), 2020080409 (20643169086719), 2020080715 (20643169086719), 2020081032 (20643169086719), 2020081033 (20643169086719), 2020090631 (20643169086719), 2020100785 (20643169086719), 2020101109 (20643169086719), 2020110380 (20643169086719), 202011C197 (20643169086719), 202011C243 (20643169086719), 202011C244 (20643169086719), 2021010033 (20643169086719), 2021010034 (20643169086719), 2021011166 (20643169086719), 2021020487 (20643169086719), 2021020798 (20643169086719), 2021020986 (20643169086719), 2021020987 (20643169086719), 202102C091 (20643169086719), 202102C092 (20643169086719), 202102C093 (20643169086719), 2021030719 (20643169086719), 2021030720 (20643169086719), 2021031307 (20643169086719), 2021040872 (20643169086719), 2021041147 (20643169086719), 2021041148 (20643169086719), 2021050634 (20643169086719), 202105C140 (20643169086719), 202105C141 (20643169086719), 202105C142 (20643169086719), 202106C025 (20643169086719).\n\nExpiration date range: 09/30/2020 - 05/19/2024", "firm_fei_number": "1000116158", "recalling_firm": "Medtronic Perfusion Systems", "address_1": "7611 Northland Dr N", "city": "Brooklyn Park", "state": "MN", "postal_code": "55428-1088", "additional_info_contact": "763-391-9000", "reason_for_recall": "Potential for a wire protrusion through the left heart vent catheter tip", "root_cause_description": "Process control", "action": "On about 08/24/2021, Medtronic notified customers via 2-day tracked mail letter titled, \"URGENT MEDICAL DEVICE RECALL DLP Left Heart Vent Catheters.\" The letter instructed customers identify and quarantine all affected DLP Left heart Vent Catheters, return all unused affected product in inventory to Medtronic by contacting Medtronic Customer Service at 1-800-854-3570 and to contact your local Medtronic Representative can assist you in the return of this product, and complete and return the provided Customer Confirmation Form and email to rs.cfqfca@medtronic.com. Additional instructions included to notify anyone within your organization that should be aware or to any organization where the potentially affected devices have been transferred.", "product_quantity": "51,494 units", "distribution_pattern": "Nationwide distribution to AL, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI. \n\nInternational distribution to Albania, Algeria, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Pakistan, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, Yemen.", "openfda": { "k_number": [ "K913940", "K123591", "K192422", "K834352", "K093866", "K091596", "K202620", "K221397", "K884337", "K223824", "K040165", "K190167", "K112239", "K081049", "K161985", "K162925", "K904785", "K070357", "K133552", "K052575", "K211100", "K152310", "K050472", "K083793", "K172394", "K160919", "K122275", "K151463", "K900320", "K924227", "K250529", "K233248", "K232321", "K153304", "K102176", "K262165", "K120086", "K012143", "K112541", "K183174", "K221044", "K100789" ], "registration_number": [ "3002807314", "9617601", "1721676", "1047843", "3012536737", "3003955307", "3013288201", "9612164", "1721504", "3005334138", "3007603855", "3015225571", "3004859241", "1056553", "1225698", "3002648230", "1319639", "2184009", "3010665433", "3015309643", "1123137", "3005070406", "3020950818", "3007014520", "3005941719", "3027305778", "3007113487", "2953359", "2182269", "2124215", "1000121056", "2939561", "3019807891", "2024311", "9681260", "2017865", "2011171", "3012179728", "3033589330", "3015970743", "2135147", "2182208", "1928237", "2183744", "3006950086", "9611665" ], "fei_number": [ "1000123180", "3002807314", "1721676", "1047843", "3012536737", "1000138054", "3003955307", "3013288201", "3002534070", "1721504", "3007603855", "3005334138", "3015225571", "3002806434", "3004859241", "3002648230", "3002807111", "1000116158", "3010665433", "3015309643", "3002807095", "3001451473", "3005070406", "3020950818", "3007014520", "3027305778", "3007113487", "2182269", "3002806565", "2124215", "3004635528", "1000121056", "3019807891", "2024311", "2017865", "2011171", "3012179728", "1000132370", "3033589330", "3015970743", "2182208", "1928237", "2183744", "3006950086", "3000215205" ], "device_name": "Catheter, Steerable", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1280", "device_class": "2" } } ] }