{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "85227", "product_res_number": "Z-0130-2010", "event_date_initiated": "2009-09-09", "event_date_posted": "2009-11-09", "recall_status": "Terminated", "event_date_terminated": "2012-05-29", "res_event_number": "53294", "product_code": "LWS", "product_description": "This device is not approved in the United States.\nMedtronic Virtuoso DR, D164AWG. Medtronic, Inc., Minneapolis, MN 55432 USA.", "code_info": "serial numbers: PVV600002S, PVV600003S, PVV600005S, PVV600008S, PVV600009S, PVV600010S, PVV600011S, PVV600013S, PVV600015S, PVV600016S, PVV600017S, PVV600018S, PVV600019S, PVV600020S, PVV600022S, PVV600023S, PVV600027S, PVV600028S, PVV600029S, PVV600030S, PVV600031S, PVV600033S, PVV600035S, PVV600036S, PVV600038S, PVV600040S, PVV600041S, PVV600043S, PVV600044S, PVV600045S, PVV600046S, PVV600047S, PVV600048S, PVV600049S, PVV600050S, PVV600054S, PVV600055S, PVV600056S, PVV600057S, PVV600058S, PVV600059S, PVV600060S, PVV600061S, PVV600062S, PVV600063S, PVV600064S, PVV600065S, PVV600066S, PVV600067S, PVV600069S, PVV600070S, PVV600071S, PVV600072S, PVV600073S, PVV600075S, PVV600076S, PVV600078S, PVV600079S, PVV600080S, PVV600082S, PVV600083S, PVV600084S, PVV600087S, PVV600088S, PVV600089S, PVV600090S, PVV600091S, PVV600092S, PVV600093S, PVV600094S, PVV600096S, PVV600097S, PVV600098S, PVV600100S, PVV600102S, PVV600103S, PVV600104S, PVV600105S, PVV600106S, PVV600107S, PVV600108S, PVV600109S, PVV600110S, PVV600111S, PVV600112S, PVV600114S, PVV600115S, PVV600116S, PVV600117S, PVV600118S, PVV600119S, PVV600120S, PVV600122S, PVV600124S, PVV600125S, PVV600126S, PVV600128S, PVV600129S, PVV600130S, PVV600131S, PVV600133S, PVV600134S, PVV600137S, PVV600138S, PVV600139S, PVV600140S, PVV600141S, PVV600142S, PVV600143S, PVV600144S, PVV600146S, PVV600147S, PVV600148S, PVV600149S, PVV600150S, PVV600151S, PVV600153S, PVV600154S, PVV600156S, PVV600157S, PVV600158S, PVV600159S, PVV600161S, PVV600162S, PVV600163S, PVV600164S, PVV600180S, PVV600184S, PVV600185S, PVV600188S, PVV600195S, PVV600199S, PVV600202S, PVV600203S, PVV600207S, PVV600214S, PVV600215S, PVV600216S, PVV600217S, PVV600218S, PVV600219S, PVV600221S, PVV600222S, PVV600223S, PVV600224S, PVV600226S, PVV600227S, PVV600228S, PVV600230S, PVV600232S, PVV600233S, PVV600234S, PVV600235S, PVV600236S, PVV600237S, PVV600238S, PVV600246S, PVV600251S, PVV600263S, PVV600265S, PVV600267S, PVV600268S, PVV600270S, PVV600272S, PVV600273S, PVV600281S, PVV600284S, PVV600288S, PVV600296S, PVV600302S, PVV600303S, PVV600315S, PVV600322S, PVV600331S, PVV600332S, PVV600334S, PVV600337S, PVV600339S, PVV600349S, PVV600350S, PVV600351S, PVV600352S, PVV600354S, PVV600355S, PVV600356S, PVV600359S, PVV600360S, PVV600363S, PVV600364S, PVV600379S, PVV600380S, PVV600383S, PVV600392S, PVV600394S, PVV600397S, PVV600400S, PVV600405S, PVV600408S, PVV600410S, PVV600414S, PVV600419S, PVV600420S, PVV600433S, PVV600437S, PVV600439S, PVV600442S, PVV600445S, PVV600446S, PVV600448S, PVV600450S, PVV600452S, PVV600453S, PVV600458S, PVV600461S, PVV600464S, PVV600465S, PVV600467S, PVV600471S, PVV600479S, PVV600485S, PVV600491S, PVV600495S, PVV600501S, PVV600503S, PVV600504S, PVV600505S, PVV600507S, PVV600508S, PVV600512S, PVV600516S, PVV600518S, PVV600521S, PVV600526S, PVV600527S, PVV600530S, PVV600535S, PVV600548S, PVV600554S, PVV600557S, PVV600560S, PVV600567S, PVV600572S, PVV600578S, PVV600579S, PVV600583S, PVV600585S, PVV600587S, PVV600588S, PVV600591S, PVV600597S, PVV600600S, PVV600603S, PVV600605S, PVV600606S, PVV600612S, PVV600613S, PVV600614S, PVV600615S, PVV600616S, PVV600617S, PVV600623S, PVV600624S, PVV600635S, PVV600641S, PVV600642S, PVV600643S, PVV600646S, PVV600647S, PVV600649S, PVV600651S, PVV600656S, PVV600660S, PVV600661S, PVV600669S, PVV600670S, PVV600675S, PVV600679S, PVV600681S, PVV600693S, PVV600694S, PVV600707S, PVV600709S, PVV600710S, PVV600718S, PVV600722S, PVV600724S, PVV600727S, PVV600729S, PVV600730S, PVV600732S, PVV600733S, PVV600740S, PVV600742S, PVV600751S, PVV600768S, PVV600786S, PVV600787S, PVV600793S, PVV600795S, PVV600803S, PVV600810S, PVV600820S, PVV600824S, PVV600842S, PVV600846S, PVV600850S, PVV600855S, PVV600863S, PVV600871S, PVV600874S, PVV600875S, PVV600880S, PVV600881S, PVV600888S, PVV600896S, PVV600898S, PVV600899S, PVV600900S, PVV600901S, PVV600902S, PVV600903S, PVV600904S, PVV600905S, PVV600906S, PVV600907S, PVV600909S, PVV600910S, PVV600912S, PVV600913S, PVV600914S, PVV600915S, PVV600916S, PVV600918S, PVV600919S, PVV600920S, PVV600922S, PVV600923S, PVV600924S, PVV600925S, PVV600926S, PVV600927S, PVV600928S, PVV600930S, PVV600932S, PVV600933S, PVV600936S, PVV600940S, PVV600941S, PVV600944S, PVV600946S, PVV600951S, PVV600954S, PVV600960S, PVV600961S, PVV600963S, PVV600965S, PVV600970S, PVV600976S, PVV600981S, PVV600984S, PVV600986S, PVV600990S, PVV600993S, PVV600995S, PVV600999S, PVV601005S, PVV601016S, PVV601027S, PVV601034S, PVV601086S, PVV601089S, PVV601092S, PVV601097S, PVV601102S, PVV601111S, PVV601112S, PVV601113S, PVV601130S, PVV601132S, PVV601134S, PVV601136S, PVV601141S, PVV601147S, PVV601150S, PVV601151S, PVV601156S, PVV601159S, PVV601163S, PVV601169S, PVV601174S, PVV601175S, PVV601181S, PVV601196S, PVV601202S, PVV601204S, PVV601222S, PVV601223S, PVV601224S, PVV601225S, PVV601226S, PVV601227S, PVV601228S, PVV601229S, PVV601230S, PVV601231S, PVV601232S, PVV601233S, PVV601234S, PVV601235S, PVV601236S, PVV601239S, PVV601242S, PVV601243S, PVV601244S, PVV601245S, PVV601252S, PVV601256S, PVV601286S, PVV601292S, PVV601343S, PVV601344S, PVV601350S, PVV601355S, PVV601358S, PVV601362S, PVV603655S, PVV603658S, PVV603660S, PVV603670S.", "firm_fei_number": "2182208", "recalling_firm": "Medtronic Inc. Cardiac Rhythm Disease Managment", "address_1": "8200 Coral Sea St. N.E.", "city": "Saint Paul", "state": "MN", "postal_code": "55112", "additional_info_contact": "763-514-4000", "reason_for_recall": "A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionalit", "root_cause_description": "Nonconforming Material/Component", "action": "An \"Important Medical Device Information\" letter, dated September 2009 was hand delivered by Medtronic Representatives beginning 09/09/09. The letter describes the issue, identifies affected devices and provides recommendations for patients with devices in the affected subset.. A Patient letter was mailed to patients beginning 09/28/09.\n\nFor additional information: \nDoctors are advised to contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636;\nDevice tracking managers are advised to contact your Medtronic representative, or the Patient Registration Department at 1-800-328-2518 x41832; and\nPatients are advised to contact Medtronic Patient Services number at 800-551-5544 ext. 41835.", "product_quantity": "439", "distribution_pattern": "Worldwide distribution (except Idaho and Wyoming) including countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Norway, Portugal, Saudi Arabi, Spain, Sweden, Switzerland, Turkey and United Kingdom.", "openfda": { "pma_number": [ "P920015", "P030035", "P930035", "P110042", "P980016", "P970024", "P940024", "P890061", "P910073", "P910023", "P980050", "P880086", "P880006", "P010012", "P830060", "P220012", "P010031", "P980023", "P050023", "P940008", "P980049", "P950022", "P030054", "P900061", "P910077", "P970013", "P960040" ], "registration_number": [ "1828132", "3014461810", "3003120897", "3002807314", "1225687", "3005334138", "3008988055", "9616693", "3018094310", "2022502", "2011171", "2032521", "2133641", "1000121056", "2135338", "3010273872", "2124215", "3033257494", "1000165971", "3002806603", "3004961578", "3009380063", "1423662", "3013674629", "3010288227", "3008159616", "3015453963", "2030624", "3004105270", "3003276151", "3006705815", "3013596024", "2183744", "3015544746", "2649622", "2183787", "2182208", "9610139", "3013500228", "3003932293", "2648729", "3004593495", "2017865", "3008494315", "3008973940", "3002807561", "3013288201", "3011120183", "9614453", "3012552532", "1028232", "3004209178" ], "fei_number": [ "1828132", "3014461810", "3003120897", "3002807314", "3005334138", "3008988055", "3018094310", "2022502", "2011171", "1000121056", "3010273872", "2124215", "3033257494", "1000165971", "3005700659", "3003574398", "3002806603", "3004961578", "3009380063", "3002807576", "3013674629", "3010288227", "3008159616", "3015453963", "3004105270", "3004369318", "3003276151", "3006705815", "3000215273", "3013596024", "2183744", "3015544746", "2649622", "2183787", "2182208", "3008377825", "3002806500", "3013500228", "3003932293", "2648729", "3004593495", "2017865", "3008973940", "3002807561", "3002618605", "3011120183", "3013288201", "3000203466", "3000206435", "3001451463", "3012552532", "1028232" ], "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }