{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190387", "product_res_number": "Z-0390-2022", "event_date_initiated": "2021-11-08", "event_date_created": "2021-12-16", "recall_status": "Terminated", "event_date_terminated": "2026-05-04", "res_event_number": "89054", "product_code": "NVY", "pma_numbers": [ "P920015" ], "product_description": "Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72", "code_info": "Sprint Quattro Lead, Product/CFN 6935M72,  UDI 00643169550919, Serial Numbers: TDL440798V, TDL475850V, TDL473645V, TDL386490V, TDL446689V, TDL458696V, TDL398634V, TDL440035V, TDL458694V, TDL397987V, TDL469404V, TDL469730V, TDL469411V, TDL473637V, TDL434492V, TDL433920V, TDL469403V, TDL397982V, TDL448256V, TDL398632V, TDL424268V, TDL448531V, TDL458699V, TDL460247V, TDL410929V, TDL405398V, TDL440809V, TDL448519V, TDL410295V, TDL410332V, TDL445702V, TDL368164V, TDL378146V, TDL446690V, TDL386481V, TDL458695V, TDL448518V, TDL448258V, TDL433896V, TDL446674V, TDL397974V, TDL386494V, TDL429017V, TDL397966V, TDL369718V, TDL424266V, TDL445620V, TDL445705V, TDL440984V, TDL440027V, TDL386489V, TDL403279V, TDL405769V, TDL434493V, TDL440803V, TDL445618V, TDL448527V, TDL433902V, TDL440971V, TDL440977V, TDL393417V, TDL433899V, TDL445712V, TDL403276V, TDL410915V, TDL433921V, TDL410334V, TDL414801V, TDL395189V, TDL429015V, TDL410291V, TDL410296V, TDL445703V, TDL368162V, TDL397975V, TDL393407V, TDL401828V, TDL423546V, TDL410331V, TDL431773V, TDL345939V, TDL350436V, TDL410916V, TDL368172V, TDL386480V, TDL440026V, TDL386477V, TDL410328V, TDL410301V, TDL410912V, TDL397992V, TDL344964V, TDL397985V, TDL431745V, TDL349616V, TDL405394V, TDL369722V, TDL433898V, TDL433909V, TDL424273V, TDL393401V, TDL423555V, TDL424267V, TDL397955V, TDL410905V, TDL349118V, TDL423556V, TDL350442V, TDL386479V, TDL368161V, TDL431777V, TDL431778V, TDL330398V, TDL381963V, TDL326160V, TDL345936V, TDL414787V, TDL386499V, TDL424269V, TDL386495V, TDL397967V, TDL405399V, TDL327272V, TDL405767V, TDL386493V, TDL315797V, TDL414793V, TDL386486V, TDL410341V, TDL386487V, TDL361821V, TDL386476V, TDL397983V, TDL312450V, TDL395193V, TDL378138V, TDL393408V, TDL337172V, TDL321443V, TDL395190V, TDL386496V, TDL397977V, TDL326159V, TDL369709V, TDL386497V, TDL369720V, TDL397958V, TDL298585V, TDL321456V, TDL386483V, TDL369713V, TDL397973V, TDL386498V, TDL386485V, TDL349115V, TDL336148V, TDL393409V, TDL344961V, TDL350065V, TDL337169V, TDL393405V, TDL349559V, TDL343795V, TDL393400V, TDL294118V, TDL393403V, TDL316186V, TDL368175V, TDL337170V, TDL326110V, TDL316181V, TDL323585V, TDL321171V, TDL315812V, TDL316169V, TDL276334V, TDL298584V, TDL199017V  UDI 00613994718877, Serial Numbers: TDL098796V, TDL046363V, TDL016560V, TDL016558V, TDL016557V, TDL002704V, TDL010685V  UDI 00643169309784, Serial Numbers: TDL192485V, TDL187462V", "firm_fei_number": "2182208", "recalling_firm": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)", "address_1": "8200 Coral Sea St Ne", "city": "Mounds View", "state": "MN", "postal_code": "55112-4391", "additional_info_contact": "Patient Services\n800-551-5544", "reason_for_recall": "The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: \"This patient has a complete MR conditional system implanted.\"", "root_cause_description": "Error in labeling", "action": "On 09-Nov-2021, Medtronic initiated mailing the patient letter, including a corrected Medical Device Identification Card, to impacted patients. In addition, on 08-Nov-2021, physicians following impacted patients were sent a physician letter explaining the correction.", "product_quantity": "187 Medical Device Cards", "distribution_pattern": "US, Canada, Northern Mariana Islands", "openfda": { "pma_number": [ "P060039", "P020030", "P850089", "P960006", "P910073", "P950001", "P990001", "P960030", "P980023", "P240036", "P950022", "P960004", "P030036", "P830061", "P050046", "P960013", "P950024", "P920015", "P930039" ], "registration_number": [ "1000121056", "9610139", "2032521", "2030624", "3004961578", "3003932293", "2017865", "3015453963", "1225687", "3018094310", "2649622", "3002807314", "1828132", "3003276151", "3003120897", "3008494315", "1028232", "3009380063", "3010273872", "3011120183", "3008973940", "1423662", "2011171", "3013288201", "2183787", "2134604", "3016678045", "3014461810", "2182208", "3002807561", "9616693", "3004105270", "3006705815", "2124215", "9614453", "2648729" ], "fei_number": [ "1000121056", "3004961578", "2017865", "3003932293", "3015453963", "3018094310", "2649622", "3002807314", "3001451463", "1828132", "3003276151", "3003120897", "1028232", "3002807576", "3009380063", "3003574398", "3010273872", "3011120183", "3008973940", "3000215273", "2011171", "3013288201", "2183787", "3002807561", "3016678045", "3014461810", "2182208", "3006705815", "3002623849", "3004105270", "3002618605", "2124215", "3002806500", "3000206435", "3008377825", "2648729" ], "device_name": "Permanent Defibrillator Electrodes", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }