Class 2 Device Recall OmniaSecure

• Date Initiated by Firm: September 17, 2026
• Date Posted: October 23, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0285-2027
• Recall Event ID: 99970
• PMA Number: P240036
• Product Classification: Permanent defibrillator electrodes - Product Code NVY
• Product: OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with an RV defibrillation coil electrode. The lead is designed for pacing, sensing, cardioversion, and defibrillation therapies.
• Code Information: 3930M74 UDI-DI 00763000643430, 00763000643447, 00763000759919, 00199150001187 Serial Nos. CDD401008V CDD401100V CDD401499V CDD401655V CDD401951V CDD402630V CDD402652V CDD402658V CDD402681V CDD403969V CDD403996V CDD404002V CDD404005V CDD404010V CDD404013V CDD404049V CDD404050V CDD404068V CDD404095V CDD404096V CDD404102V CDD404103V CDD404104V CDD404107V CDD404164V CDD404177V CDD408398V CDD408399V CDD408405V CDD408407V CDD408411V CDD408414V CDD408425V CDD409092V CDD409098V CDD409099V CDD409132V CDD409134V CDD409164V CDD409168V CDD409220V CDD409225V CDD409226V CDD409891V CDD409892V CDD409894V CDD409895V CDD409896V CDD409909V CDD409910V CDD409914V CDD409937V CDD409949V CDD409950V CDD409951V CDD409999V CDD410008V CDD410574V CDD410583V CDD410597V CDD410602V CDD410611V CDD410613V CDD410614V CDD410615V CDD410616V CDD410617V CDD410634V CDD410635V CDD410641V CDD410656V CDD410748V CDD410749V CDD410750V CDD410752V CDD410753V CDD410756V CDD410757V CDD410758V CDD410760V CDD410761V CDD410762V CDD410763V CDD410792V CDD410836V CDD410848V CDD410875V CDD410908V CDD410938V CDD410958V CDD410959V CDD410982V CDD410983V CDD410987V CDD411007V CDD411013V CDD411014V CDD411016V CDD411749V CDD411760V CDD411780V CDD411782V CDD411795V CDD411805V CDD412823V CDD412825V CDD412829V CDD412837V CDD412838V CDD412839V CDD412843V CDD412847V CDD412851V CDD412855V CDD412860V CDD412869V CDD412871V CDD412872V CDD412873V CDD412874V CDD412876V CDD412877V CDD412882V CDD412883V CDD412884V CDD412885V CDD412888V CDD412892V CDD412893V CDD412894V CDD412895V CDD412896V CDD412897V CDD412908V CDD412923V CDD412926V CDD412934V CDD412940V CDD412941V CDD412942V CDD412943V CDD412944V CDD412945V CDD412946V CDD412947V CDD412948V CDD412949V CDD412957V CDD412958V CDD412962V CDD412963V CDD412965V CDD412966V CDD412968V CDD412970V CDD412971V CDD412973V CDD412981V CDD412982V CDD412983V CDD412985V CDD412987V CDD412992V CDD412996V CDD412998V CDD413011V CDD413039V CDD413049V CDD413075V CDD413076V CDD413077V CDD413081V CDD413084V CDD413087V CDD413088V CDD413090V CDD413091V CDD413100V CDD413101V CDD413103V CDD413104V CDD413105V CDD413106V CDD413141V CDD413142V CDD413146V CDD413148V CDD413149V CDD413151V CDD413152V CDD413154V CDD413155V CDD413156V CDD413157V CDD413160V CDD413163V CDD413164V CDD413186V CDD413187V CDD413188V CDD413189V CDD413190V CDD413199V CDD413200V CDD413224V CDD413248V CDD413249V CDD413253V CDD413254V CDD414651V CDD414654V CDD414668V CDD414695V CDD414703V CDD414706V CDD408468V CDD408469V CDD408513V CDD408539V CDD408543V CDD408545V CDD408635V CDD408636V CDD408647V CDD408651V CDD408675V CDD408680V CDD408681V CDD408682V CDD408683V CDD408697V CDD408712V CDD408713V CDD408770V CDD408771V CDD408779V CDD408783V CDD408784V CDD408785V CDD408802V CDD408809V CDD408811V CDD408815V CDD408817V CDD408906V CDD408908V CDD408911V CDD408925V CDD408946V CDD408955V CDD408956V CDD408959V CDD408960V CDD408961V CDD408971V CDD408972V CDD408975V CDD408976V CDD409836V CDD409837V CDD409843V CDD409849V CDD409850V CDD409851V CDD409852V CDD409853V CDD409854V CDD409859V CDD409867V CDD409869V CDD411021V CDD411028V CDD411037V CDD411039V CDD411041V CDD411042V CDD411082V CDD411085V CDD411090V CDD411092V CDD411147V CDD411148V CDD411161V CDD411394V CDD411397V CDD411398V CDD411413V CDD411414V CDD411709V CDD411710V CDD411715V CDD411717V CDD411718V CDD411720V CDD411721V CDD411729V CDD411730V CDD411731V CDD411732V CDD411733V CDD411734V CDD412796V CDD412797V CDD412798V CDD412799V CDD412800V CDD412802V CDD412816V CDD413256V CDD413257V CDD413258V CDD413260V CDD413275V CDD413276V CDD413277V CDD413278V CDD413279V CDD413289V CDD413299V CDD413300V CDD413308V CDD413311V CDD413312V CDD413313V CDD413314V CDD413315V CDD413316V CDD413317V CDD413318V CDD413330V CDD413332V CDD413333V CDD413334V CDD413335V CDD413336V CDD413337V CDD413338V CDD413339V CDD413340V CDD413341V CDD413342V CDD413344V CDD413345V CDD413346V CDD413373V CDD413376V CDD413392V CDD413393V CDD413394V CDD413395V CDD413396V CDD413398V CDD413402V CDD413403V CDD413404V CDD413406V CDD413407V CDD413408V CDD413409V CDD413411V CDD413412V CDD413413V CDD413414V CDD413415V CDD413417V CDD413418V CDD413419V CDD413425V CDD413430V CDD413431V CDD413440V CDD413443V CDD413444V CDD413445V CDD413446V CDD413447V CDD413448V CDD413449V CDD413457V CDD413458V CDD413459V CDD413460V CDD413526V CDD413527V CDD413537V CDD413538V CDD413539V CDD413540V CDD413542V CDD413543V CDD413549V CDD413550V CDD414782V CDD414787V CDD414789V CDD414790V CDD414792V CDD414886V CDD408607V CDD408717V CDD408718V CDD408720V CDD408725V CDD408732V CDD408734V CDD408735V CDD408737V CDD408826V CDD408830V CDD408831V CDD408841V CDD408842V CDD408850V CDD408851V CDD408852V CDD408853V CDD408855V CDD408856V CDD408857V CDD408877V CDD408878V CDD408880V CDD408893V CDD409042V CDD409045V CDD409046V CDD409049V CDD409051V CDD409053V CDD409056V CDD409065V CDD409066V CDD409070V CDD410674V CDD410675V CDD410676V CDD410679V CDD410686V CDD410687V CDD411093V CDD411094V CDD411096V CDD411097V CDD411098V CDD411099V CDD411100V CDD411101V CDD411102V CDD411103V CDD411105V CDD411107V CDD411110V CDD411111V CDD411112V CDD411113V CDD411114V CDD411117V CDD411118V CDD411120V CDD411121V CDD411124V CDD411125V CDD411127V CDD411184V CDD411185V CDD411273V CDD411304V CDD411306V CDD411322V CDD411323V CDD411331V CDD411597V CDD411598V CDD411601V CDD411610V CDD411615V CDD411625V CDD411627V CDD411635V CDD411643V CDD411658V CDD411659V CDD411662V CDD411690V CDD409805V CDD409810V CDD409830V CDD410703V CDD410725V CDD411167V CDD411171V CDD411176V CDD411188V CDD411199V CDD411213V CDD411226V CDD411228V CDD411258V CDD411283V CDD411295V CDD411340V CDD411343V CDD411380V CDD411599V CDD411602V CDD411603V CDD411604V CDD411607V CDD411613V 3930M79 UDI-DI 00763000643454, 00763000643461, 00199150001170 Serial Nos. CDD604403V CDD604404V CDD604414V CDD604418V CDD604489V CDD604494V CDD604496V CDD604497V CDD604498V CDD604499V CDD604502V CDD604505V CDD604507V CDD604538V CDD604540V CDD606023V CDD606029V CDD606033V CDD606043V CDD606077V CDD606078V CDD606081V CDD606083V CDD606084V CDD606086V CDD606088V CDD606089V CDD606090V CDD606091V CDD606095V CDD606112V CDD606118V CDD606119V CDD606120V CDD606121V CDD606122V CDD606123V CDD606125V CDD606126V CDD606127V CDD606128V CDD606130V CDD606131V CDD606132V CDD606133V CDD606135V CDD606137V CDD606139V CDD606140V CDD606142V CDD606143V CDD606144V CDD606145V CDD606146V CDD606147V CDD606149V CDD606151V CDD606159V CDD606161V CDD606163V CDD606165V CDD606166V CDD606169V CDD606170V CDD606171V CDD606172V CDD606173V CDD606175V CDD606177V CDD606178V CDD606183V CDD606188V CDD606194V CDD606203V CDD606204V CDD606205V CDD606210V CDD606211V CDD606212V CDD606213V CDD606214V CDD606217V CDD606218V CDD606219V CDD606221V CDD606222V CDD606223V CDD606224V CDD606225V CDD606226V CDD606227V CDD606228V CDD606229V CDD606230V CDD606231V CDD606232V CDD606234V CDD606235V CDD606237V CDD606238V CDD607193V CDD607205V CDD607207V CDD607212V CDD607213V CDD607235V CDD607238V CDD607239V CDD607240V CDD607245V CDD607246V CDD607250V CDD607254V CDD607255V CDD607256V CDD607257V CDD607258V CDD607259V CDD607264V CDD607265V CDD607266V CDD607267V CDD607268V CDD607269V CDD607270V CDD607271V CDD607272V CDD607273V CDD607274V CDD607275V CDD607276V CDD607278V CDD607287V CDD607293V CDD607295V CDD607296V CDD607855V CDD607872V CDD607873V CDD607878V CDD607879V CDD607883V CDD607886V CDD607888V CDD607903V CDD607904V CDD607905V CDD607929V CDD607959V CDD607971V CDD607972V CDD607975V CDD607978V CDD607980V CDD607990V CDD607996V CDD607999V CDD608001V CDD608006V CDD608010V CDD608012V CDD608013V CDD608014V CDD608015V CDD608017V CDD608018V CDD608020V CDD608043V CDD609182V CDD609183V CDD609184V CDD609185V CDD609186V CDD609187V CDD609188V CDD609211V CDD609214V CDD609219V CDD609220V CDD609223V CDD609225V CDD609226V CDD609241V CDD609242V CDD609243V CDD609245V CDD609246V CDD609247V CDD609248V CDD609249V CDD609250V CDD609251V CDD609252V CDD609253V CDD609279V CDD609280V CDD609290V CDD609292V CDD609293V CDD609423V CDD609425V CDD609444V CDD607300V CDD607301V CDD607302V CDD609286V CDD607327V CDD607353V
• FEI Number: 2182208
• Recalling Firm/ Manufacturer: Medtronic, Inc.; 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Technical Services; 800-638-1991
• Manufacturer 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.
• FDA Determined Cause: 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.
• Quantity in Commerce: 717
• Distribution: US Nationwide distribution including in the states of AZ, CA, CT, DE, FL, GA, IN, KS, KY, LA, MA, 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, Ireland, Israel, Italy, Japan, New Zealand, Poland, Reunion, Slovenia, Spain, Sweden, United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NVY