{ "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": "2026-10-29", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "223019", "product_res_number": "Z-0285-2027", "event_date_initiated": "2026-09-17", "event_date_posted": "2026-10-23", "recall_status": "Open, Classified", "res_event_number": "99970", "product_code": "NVY", "pma_numbers": [ "P240036" ], "product_description": "OmniaSecure Model 3930M,\r\n\r\nLEAD 3930M74 74 CM DF4 MR\r\n3930M74\r\n\r\nLEAD 3930M79 79 CM DF4 MR\r\n3930M79\r\n\r\nThe Medtronic OmniaSecure\" Model 3930M lead is a steroid eluting,\r\nintegrated bipolar, nonretractable screw-in, catheter delivered, transvenous\r\nventricular lead with an RV defibrillation coil electrode. The lead is designed\r\nfor pacing, sensing, cardioversion, and defibrillation therapies.", "code_info": "3930M74\nUDI-DI 00763000643430, 00763000643447,\n00763000759919, 00199150001187\nSerial Nos.\nCDD401008V\nCDD401100V\nCDD401499V\nCDD401655V\nCDD401951V\nCDD402630V\nCDD402652V\nCDD402658V\nCDD402681V\nCDD403969V\nCDD403996V\nCDD404002V\nCDD404005V\nCDD404010V\nCDD404013V\nCDD404049V\nCDD404050V\nCDD404068V\nCDD404095V\nCDD404096V\nCDD404102V\nCDD404103V\nCDD404104V\nCDD404107V\nCDD404164V\nCDD404177V\nCDD408398V\nCDD408399V\nCDD408405V\nCDD408407V\nCDD408411V\nCDD408414V\nCDD408425V\nCDD409092V\nCDD409098V\nCDD409099V\nCDD409132V\nCDD409134V\nCDD409164V\nCDD409168V\nCDD409220V\nCDD409225V\nCDD409226V\nCDD409891V\nCDD409892V\nCDD409894V\nCDD409895V\nCDD409896V\nCDD409909V\nCDD409910V\nCDD409914V\nCDD409937V\nCDD409949V\nCDD409950V\nCDD409951V\nCDD409999V\nCDD410008V\nCDD410574V\nCDD410583V\nCDD410597V\nCDD410602V\nCDD410611V\nCDD410613V\nCDD410614V\nCDD410615V\nCDD410616V\nCDD410617V\nCDD410634V\nCDD410635V\nCDD410641V\nCDD410656V\nCDD410748V\nCDD410749V\nCDD410750V\nCDD410752V\nCDD410753V\nCDD410756V\nCDD410757V\nCDD410758V\nCDD410760V\nCDD410761V\nCDD410762V\nCDD410763V\nCDD410792V\nCDD410836V\nCDD410848V\nCDD410875V\nCDD410908V\nCDD410938V\nCDD410958V\nCDD410959V\nCDD410982V\nCDD410983V\nCDD410987V\nCDD411007V\nCDD411013V\nCDD411014V\nCDD411016V\nCDD411749V\nCDD411760V\nCDD411780V\nCDD411782V\nCDD411795V\nCDD411805V\nCDD412823V\nCDD412825V\nCDD412829V\nCDD412837V\nCDD412838V\nCDD412839V\nCDD412843V\nCDD412847V\nCDD412851V\nCDD412855V\nCDD412860V\nCDD412869V\nCDD412871V\nCDD412872V\nCDD412873V\nCDD412874V\nCDD412876V\nCDD412877V\nCDD412882V\nCDD412883V\nCDD412884V\nCDD412885V\nCDD412888V\nCDD412892V\nCDD412893V\nCDD412894V\nCDD412895V\nCDD412896V\nCDD412897V\nCDD412908V\nCDD412923V\nCDD412926V\nCDD412934V\nCDD412940V\nCDD412941V\nCDD412942V\nCDD412943V\nCDD412944V\nCDD412945V\nCDD412946V\nCDD412947V\nCDD412948V\nCDD412949V\nCDD412957V\nCDD412958V\nCDD412962V\nCDD412963V\nCDD412965V\nCDD412966V\nCDD412968V\nCDD412970V\nCDD412971V\nCDD412973V\nCDD412981V\nCDD412982V\nCDD412983V\nCDD412985V\nCDD412987V\nCDD412992V\nCDD412996V\nCDD412998V\nCDD413011V\nCDD413039V\nCDD413049V\nCDD413075V\nCDD413076V\nCDD413077V\nCDD413081V\nCDD413084V\nCDD413087V\nCDD413088V\nCDD413090V\nCDD413091V\nCDD413100V\nCDD413101V\nCDD413103V\nCDD413104V\nCDD413105V\nCDD413106V\nCDD413141V\nCDD413142V\nCDD413146V\nCDD413148V\nCDD413149V\nCDD413151V\nCDD413152V\nCDD413154V\nCDD413155V\nCDD413156V\nCDD413157V\nCDD413160V\nCDD413163V\nCDD413164V\nCDD413186V\nCDD413187V\nCDD413188V\nCDD413189V\nCDD413190V\nCDD413199V\nCDD413200V\nCDD413224V\nCDD413248V\nCDD413249V\nCDD413253V\nCDD413254V\nCDD414651V\nCDD414654V\nCDD414668V\nCDD414695V\nCDD414703V\nCDD414706V\nCDD408468V\nCDD408469V\nCDD408513V\nCDD408539V\nCDD408543V\nCDD408545V\nCDD408635V\nCDD408636V\nCDD408647V\nCDD408651V\nCDD408675V\nCDD408680V\nCDD408681V\nCDD408682V\nCDD408683V\nCDD408697V\nCDD408712V\nCDD408713V\nCDD408770V\nCDD408771V\nCDD408779V\nCDD408783V\nCDD408784V\nCDD408785V\nCDD408802V\nCDD408809V\nCDD408811V\nCDD408815V\nCDD408817V\nCDD408906V\nCDD408908V\nCDD408911V\nCDD408925V\nCDD408946V\nCDD408955V\nCDD408956V\nCDD408959V\nCDD408960V\nCDD408961V\nCDD408971V\nCDD408972V\nCDD408975V\nCDD408976V\nCDD409836V\nCDD409837V\nCDD409843V\nCDD409849V\nCDD409850V\nCDD409851V\nCDD409852V\nCDD409853V\nCDD409854V\nCDD409859V\nCDD409867V\nCDD409869V\nCDD411021V\nCDD411028V\nCDD411037V\nCDD411039V\nCDD411041V\nCDD411042V\nCDD411082V\nCDD411085V\nCDD411090V\nCDD411092V\nCDD411147V\nCDD411148V\nCDD411161V\nCDD411394V\nCDD411397V\nCDD411398V\nCDD411413V\nCDD411414V\nCDD411709V\nCDD411710V\nCDD411715V\nCDD411717V\nCDD411718V\nCDD411720V\nCDD411721V\nCDD411729V\nCDD411730V\nCDD411731V\nCDD411732V\nCDD411733V\nCDD411734V\nCDD412796V\nCDD412797V\nCDD412798V\nCDD412799V\nCDD412800V\nCDD412802V\nCDD412816V\nCDD413256V\nCDD413257V\nCDD413258V\nCDD413260V\nCDD413275V\nCDD413276V\nCDD413277V\nCDD413278V\nCDD413279V\nCDD413289V\nCDD413299V\nCDD413300V\nCDD413308V\nCDD413311V\nCDD413312V\nCDD413313V\nCDD413314V\nCDD413315V\nCDD413316V\nCDD413317V\nCDD413318V\nCDD413330V\nCDD413332V\nCDD413333V\nCDD413334V\nCDD413335V\nCDD413336V\nCDD413337V\nCDD413338V\nCDD413339V\nCDD413340V\nCDD413341V\nCDD413342V\nCDD413344V\nCDD413345V\nCDD413346V\nCDD413373V\nCDD413376V\nCDD413392V\nCDD413393V\nCDD413394V\nCDD413395V\nCDD413396V\nCDD413398V\nCDD413402V\nCDD413403V\nCDD413404V\nCDD413406V\nCDD413407V\nCDD413408V\nCDD413409V\nCDD413411V\nCDD413412V\nCDD413413V\nCDD413414V\nCDD413415V\nCDD413417V\nCDD413418V\nCDD413419V\nCDD413425V\nCDD413430V\nCDD413431V\nCDD413440V\nCDD413443V\nCDD413444V\nCDD413445V\nCDD413446V\nCDD413447V\nCDD413448V\nCDD413449V\nCDD413457V\nCDD413458V\nCDD413459V\nCDD413460V\nCDD413526V\nCDD413527V\nCDD413537V\nCDD413538V\nCDD413539V\nCDD413540V\nCDD413542V\nCDD413543V\nCDD413549V\nCDD413550V\nCDD414782V\nCDD414787V\nCDD414789V\nCDD414790V\nCDD414792V\nCDD414886V\nCDD408607V\nCDD408717V\nCDD408718V\nCDD408720V\nCDD408725V\nCDD408732V\nCDD408734V\nCDD408735V\nCDD408737V\nCDD408826V\nCDD408830V\nCDD408831V\nCDD408841V\nCDD408842V\nCDD408850V\nCDD408851V\nCDD408852V\nCDD408853V\nCDD408855V\nCDD408856V\nCDD408857V\nCDD408877V\nCDD408878V\nCDD408880V\nCDD408893V\nCDD409042V\nCDD409045V\nCDD409046V\nCDD409049V\nCDD409051V\nCDD409053V\nCDD409056V\nCDD409065V\nCDD409066V\nCDD409070V\nCDD410674V\nCDD410675V\nCDD410676V\nCDD410679V\nCDD410686V\nCDD410687V\nCDD411093V\nCDD411094V\nCDD411096V\nCDD411097V\nCDD411098V\nCDD411099V\nCDD411100V\nCDD411101V\nCDD411102V\nCDD411103V\nCDD411105V\nCDD411107V\nCDD411110V\nCDD411111V\nCDD411112V\nCDD411113V\nCDD411114V\nCDD411117V\nCDD411118V\nCDD411120V\nCDD411121V\nCDD411124V\nCDD411125V\nCDD411127V\nCDD411184V\nCDD411185V\nCDD411273V\nCDD411304V\nCDD411306V\nCDD411322V\nCDD411323V\nCDD411331V\nCDD411597V\nCDD411598V\nCDD411601V\nCDD411610V\nCDD411615V\nCDD411625V\nCDD411627V\nCDD411635V\nCDD411643V\nCDD411658V\nCDD411659V\nCDD411662V\nCDD411690V\nCDD409805V\nCDD409810V\nCDD409830V\nCDD410703V\nCDD410725V\nCDD411167V\nCDD411171V\nCDD411176V\nCDD411188V\nCDD411199V\nCDD411213V\nCDD411226V\nCDD411228V\nCDD411258V\nCDD411283V\nCDD411295V\nCDD411340V\nCDD411343V\nCDD411380V\nCDD411599V\nCDD411602V\nCDD411603V\nCDD411604V\nCDD411607V\nCDD411613V\n\n3930M79\nUDI-DI 00763000643454, 00763000643461,\n00199150001170\nSerial Nos. \nCDD604403V\nCDD604404V\nCDD604414V\nCDD604418V\nCDD604489V\nCDD604494V\nCDD604496V\nCDD604497V\nCDD604498V\nCDD604499V\nCDD604502V\nCDD604505V\nCDD604507V\nCDD604538V\nCDD604540V\nCDD606023V\nCDD606029V\nCDD606033V\nCDD606043V\nCDD606077V\nCDD606078V\nCDD606081V\nCDD606083V\nCDD606084V\nCDD606086V\nCDD606088V\nCDD606089V\nCDD606090V\nCDD606091V\nCDD606095V\nCDD606112V\nCDD606118V\nCDD606119V\nCDD606120V\nCDD606121V\nCDD606122V\nCDD606123V\nCDD606125V\nCDD606126V\nCDD606127V\nCDD606128V\nCDD606130V\nCDD606131V\nCDD606132V\nCDD606133V\nCDD606135V\nCDD606137V\nCDD606139V\nCDD606140V\nCDD606142V\nCDD606143V\nCDD606144V\nCDD606145V\nCDD606146V\nCDD606147V\nCDD606149V\nCDD606151V\nCDD606159V\nCDD606161V\nCDD606163V\nCDD606165V\nCDD606166V\nCDD606169V\nCDD606170V\nCDD606171V\nCDD606172V\nCDD606173V\nCDD606175V\nCDD606177V\nCDD606178V\nCDD606183V\nCDD606188V\nCDD606194V\nCDD606203V\nCDD606204V\nCDD606205V\nCDD606210V\nCDD606211V\nCDD606212V\nCDD606213V\nCDD606214V\nCDD606217V\nCDD606218V\nCDD606219V\nCDD606221V\nCDD606222V\nCDD606223V\nCDD606224V\nCDD606225V\nCDD606226V\nCDD606227V\nCDD606228V\nCDD606229V\nCDD606230V\nCDD606231V\nCDD606232V\nCDD606234V\nCDD606235V\nCDD606237V\nCDD606238V\nCDD607193V\nCDD607205V\nCDD607207V\nCDD607212V\nCDD607213V\nCDD607235V\nCDD607238V\nCDD607239V\nCDD607240V\nCDD607245V\nCDD607246V\nCDD607250V\nCDD607254V\nCDD607255V\nCDD607256V\nCDD607257V\nCDD607258V\nCDD607259V\nCDD607264V\nCDD607265V\nCDD607266V\nCDD607267V\nCDD607268V\nCDD607269V\nCDD607270V\nCDD607271V\nCDD607272V\nCDD607273V\nCDD607274V\nCDD607275V\nCDD607276V\nCDD607278V\nCDD607287V\nCDD607293V\nCDD607295V\nCDD607296V\nCDD607855V\nCDD607872V\nCDD607873V\nCDD607878V\nCDD607879V\nCDD607883V\nCDD607886V\nCDD607888V\nCDD607903V\nCDD607904V\nCDD607905V\nCDD607929V\nCDD607959V\nCDD607971V\nCDD607972V\nCDD607975V\nCDD607978V\nCDD607980V\nCDD607990V\nCDD607996V\nCDD607999V\nCDD608001V\nCDD608006V\nCDD608010V\nCDD608012V\nCDD608013V\nCDD608014V\nCDD608015V\nCDD608017V\nCDD608018V\nCDD608020V\nCDD608043V\nCDD609182V\nCDD609183V\nCDD609184V\nCDD609185V\nCDD609186V\nCDD609187V\nCDD609188V\nCDD609211V\nCDD609214V\nCDD609219V\nCDD609220V\nCDD609223V\nCDD609225V\nCDD609226V\nCDD609241V\nCDD609242V\nCDD609243V\nCDD609245V\nCDD609246V\nCDD609247V\nCDD609248V\nCDD609249V\nCDD609250V\nCDD609251V\nCDD609252V\nCDD609253V\nCDD609279V\nCDD609280V\nCDD609290V\nCDD609292V\nCDD609293V\nCDD609423V\nCDD609425V\nCDD609444V\nCDD607300V\nCDD607301V\nCDD607302V\nCDD609286V\nCDD607327V\nCDD607353V", "firm_fei_number": "2182208", "recalling_firm": "Medtronic, Inc.", "address_1": "8200 Coral Sea St Ne", "city": "Mounds View", "state": "MN", "postal_code": "55112-4391", "additional_info_contact": "Technical Services\n800-638-1991", "reason_for_recall": "Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.", "root_cause_description": "Process design", "action": "The firm began notifying consignees on September 17, 2026. Consignees were asked to quarantine and return any affected, unused product they may have, and complete and return the Customer Confirmation Form.", "product_quantity": "717", "distribution_pattern": "US Nationwide distribution including in the states of AZ, CA, CT, DE, FL, GA, IN, KS, KY, LA, \nMA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WI, WV and the countries of Australia, Canada, Canary Islands, Finland, France, Germany, Greece, \nIreland, Israel, Italy, Japan, New Zealand, Poland, Reunion, Slovenia, Spain, Sweden, United Kingdom.", "openfda": { "device_name": "Permanent Defibrillator Electrodes", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "pma_number": [ "P050046", "P930039", "P950024", "P980023", "P020030", "P960030", "P990001", "P240036", "P950001", "P060039", "P960013", "P920015", "P910073", "P960006", "P850089", "P030036", "P830061", "P950022", "P960004" ], "registration_number": [ "3002807561", "3003276151", "2648729", "3003120897", "2183787", "2134604", "3013288201", "3011120183", "1828132", "9614453", "3014461810", "2649622", "2011171", "3010273872", "2032521", "3002807314", "3009380063", "3016678045", "9610139", "3004105270", "3004961578", "3018094310", "2017865", "3006705815", "2124215", "3015453963", "1225687", "1000121056", "3008973940", "2030624", "1423662", "2182208", "1028232", "3008494315", "3003932293", "9616693" ], "fei_number": [ "3002807561", "3000206435", "3003276151", "2648729", "3002618605", "3003120897", "3002806500", "2183787", "3013288201", "3011120183", "1828132", "3001451463", "3008377825", "3014461810", "2649622", "2011171", "3000215273", "3010273872", "3003574398", "3002807314", "3002807576", "3009380063", "3016678045", "3004105270", "3002623849", "3004961578", "3018094310", "2017865", "3006705815", "2124215", "3015453963", "1000121056", "3008973940", "2182208", "1028232", "3003932293" ] } } ] }