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U.S. Department of Health and Human Services

Class 2 Device Recall Maximo II VR

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 Class 2 Recall
Maximo II VR
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Date Posted October 21, 2010
Recall Status1 Terminated on March 15, 2012
Recall Number Z-0114-2011
Recall Event ID 55922
Premarket Approval
PMA Number
P980016/S114
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Medtronic Maximo II VR, model D284VRC. Digital single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. The Single chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single chamber rate-responsive bradycardia pacing, and ventricular tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Code Information Model D284VRC, serial numbers: PZN200002H thru PZN200019H, PZN200021H, PZN200022H, PZN200023H, PZN200024H, PZN200025H, PZN200026H, PZN200027H, PZN200029H thru PZN200044H, PZN200046H thru PZN200067H, PZN200069H thru PZN200108H, PZN200110H thru PZN200118H, PZN200120H, PZN200121H, PZN200123H thru PZN200139H, PZN200143H, PZN200144H, PZN200145H, PZN200146H, PZN200147H, PZN200148H, PZN200149H, PZN200150H, PZN200151H, PZN200152H, PZN200153H, PZN200154H, PZN200155H, PZN200156H, PZN200157H, PZN200158H, PZN200159H, PZN200160H, PZN200162H thru PZN200208H, PZN200210H thru PZN200275H, PZN200277H thru PZN200335H, PZN200337H, PZN200338H, PZN200339H, PZN200340H, PZN200341H, PZN200342H, PZN200343H, PZN200344H, PZN200345H, PZN200346H, PZN200348H, PZN200349H, PZN200350H, PZN200351H, PZN200352H, PZN200353H, PZN200354H, PZN200355H, PZN200356H, PZN200357H, PZN200358H, PZN200359H, PZN200360H, PZN200361H, PZN200362H, PZN200363H, PZN200364H, PZN200365H, PZN200366H, PZN200368H, PZN200369H, PZN200370H, PZN200371H, PZN200372H, PZN200373H, PZN200374H, PZN200375H, PZN200377H thru PZN200434H, PZN200436H thru PZN200450H, PZN200452H, PZN200453H, PZN200454H, PZN200455H, PZN200456H, PZN200457H, PZN200458H, PZN200459H, PZN200460H, PZN200461H, PZN200462H, PZN200463H, PZN200465H thru PZN200536H, PZN200538H thru PZN200569H, PZN200571H thru PZN200582H, PZN200584H thru PZN200628H, PZN200630H thru PZN200682H, PZN200684H thru PZN200763H, PZN200765H, PZN200766H, PZN200767H, PZN200768H, PZN200769H, PZN200770H, PZN200771H, PZN200772H, PZN200773H, PZN200775H thru PZN200855H, PZN200857H thru PZN200936H, PZN200938H thru PZN201009H, PZN201011H thru PZN201171H, PZN201173H thru PZN201229H, PZN201232H, PZN201233H, PZN201234H, PZN201235H, PZN201236H, PZN201237H, PZN201238H, PZN201239H, PZN201240H, PZN201242H, PZN201243H, PZN201244H, PZN201245H, PZN201246H, PZN201247H, PZN201248H, PZN201249H, PZN201250H, PZN201251H, PZN201252H, PZN201253H, PZN201254H, PZN201255H, PZN201256H, PZN201257H, PZN201258H, PZN201260H, PZN201261H, PZN201262H, PZN201263H, PZN201264H, PZN201265H, PZN201266H, PZN201267H, PZN201268H, PZN201269H, PZN201270H, PZN201272H thru PZN201690H, PZN201692H thru PZN201778H, PZN201781H, PZN201782H, PZN201783H, PZN201784H, PZN201786H thru PZN201827H, PZN201829H thru PZN201912H, PZN201914H thru PZN201934H, PZN201936H thru PZN201967H, PZN201969H thru PZN202085H, PZN202087H thru PZN202225H, PZN202227H thru PZN202269H, PZN202271H thru PZN202358H, PZN202360H thru PZN202434H, PZN202436H thru PZN202565H, PZN202567H thru PZN202624H, PZN202626H thru PZN202641H, PZN202643H, PZN202644H, PZN202645H, PZN202646H, PZN202647H, PZN202648H, PZN202649H, PZN202650H, PZN202651H, PZN202652H, PZN202653H, PZN202654H, PZN202655H, PZN202657H thru PZN202720H, PZN202722H thru PZN202732H, PZN202734H thru PZN202895H, PZN202897H thru PZN202945H, PZN202947H thru PZN202967H, PZN202971H, PZN202973H, PZN202974H, PZN202975H, PZN202976H, PZN202977H, PZN202978H, PZN202979H, PZN202980H, PZN202981H, PZN202982H, PZN202984H, PZN202985H, PZN202986H, PZN202987H, PZN202988H, PZN202989H, PZN202990H, PZN202991H, PZN202992H, PZN202993H, PZN202994H, PZN202995H, PZN202996H, PZN202998H thru PZN203024H, PZN203026H thru PZN203077H, PZN203079H thru PZN203152H, PZN203154H thru PZN203197H, PZN203199H thru PZN203228H, PZN203230H, PZN203231H, PZN203232H, PZN203233H, PZN203234H, PZN203235H, PZN203236H, PZN203238H thru PZN203392H, PZN203394H thru PZN203457H, PZN203459H thru PZN203585H, PZN203587H thru PZN203713H, PZN203715H thru PZN203802H, PZN203804H thru PZN203820H, PZN203822H, PZN203823H, PZN203824H, PZN203825H, PZN203826H, PZN203827H, PZN203828H, PZN203829H, PZN203830H, PZN203831H, PZN203834H, PZN203835H, PZN203836H, PZN203837H, PZN203838H, PZN203839H, PZN203841H, PZN203842H, PZN203843H, PZN203844H, PZN203845H, PZN203846H, PZN203847H, PZN203848H, PZN203849H, PZN203850H, PZN203851H, PZN203852H, PZN203853H, PZN203854H, PZN203855H, PZN203856H, PZN203857H, PZN203858H, PZN203859H, PZN203860H, PZN203862H, PZN203863H, PZN203864H, PZN203865H, PZN203866H, PZN203867H, PZN203869H thru PZN203994H, PZN203996H thru PZN204055H, PZN204057H thru PZN204357H, PZN204359H thru PZN204417H, PZN204419H, PZN204420H, PZN204422H thru PZN204506H, PZN204508H thru PZN204547H, PZN204549H thru PZN204624H, PZN204626H thru PZN204683H, PZN204685H thru PZN204758H, PZN204760H thru PZN204879H, PZN204883H thru PZN204974H, PZN204976H thru PZN205039H, PZN205041H thru PZN205124H, PZN205126H thru PZN205256H, PZN205258H thru PZN205344H, PZN205346H thru PZN205361H, PZN205363H thru PZN205384H, PZN205387H thru PZN205634H, PZN205636H thru PZN205687H, PZN205689H, PZN205690H, PZN205691H, PZN205692H, PZN205693H, PZN205694H, PZN205695H, PZN205696H, PZN205697H, PZN205699H thru PZN205739H, PZN205741H thru PZN205797H, PZN205799H thru PZN205843H, PZN205845H thru PZN205928H, PZN205930H thru PZN205950H, PZN205952H thru PZN205970H, PZN205973H thru PZN205988H, PZN205990H thru PZN206051H, PZN206053H thru PZN206066H, PZN206068H, PZN206069H, PZN206071H thru PZN206119H, PZN206121H, PZN206122H, PZN206123H, PZN206124H, PZN206125H, PZN206126H, PZN206127H, PZN206128H, PZN206129H, PZN206130H, PZN206131H, PZN206133H thru PZN206178H, PZN206180H thru PZN206198H, PZN206200H thru PZN206368H, PZN206370H thru PZN206522H, PZN206524H thru PZN206541H, PZN206543H thru PZN206577H, PZN206579H, PZN206580H, PZN206581H, PZN206582H, PZN206583H, PZN206584H, PZN206585H, PZN206586H, PZN206587H, PZN206589H thru PZN206615H, PZN206617H thru PZN206692H, PZN206694H, PZN206695H, PZN206696H, PZN206697H, PZN206698H, PZN206699H, PZN206700H, PZN206701H, PZN206702H, PZN206703H, PZN206704H, PZN206705H, PZN206707H thru PZN206742H, PZN206744H thru PZN206766H, PZN206768H, PZN206769H, PZN206770H, PZN206771H, PZN206772H, PZN206773H, PZN206774H, PZN206775H, PZN206776H, PZN206777H, PZN206778H, PZN206779H, PZN206781H, PZN206782H, PZN206783H, PZN206784H, PZN206785H, PZN206787H, PZN206788H, PZN206789H, PZN206790H, PZN206791H, PZN206792H, PZN206793H, PZN206794H, PZN206795H, PZN206796H, PZN206797H, PZN206798H, PZN206799H, PZN206800H, PZN206802H, PZN206803H, PZN206804H, PZN206805H, PZN206806H, PZN206807H, PZN206808H, PZN206809H, PZN206810H, PZN206811H, PZN206812H, PZN206813H, PZN206814H, PZN206815H, PZN206817H, PZN206820H thru PZN206853H, PZN206855H thru PZN206877H, PZN206879H thru PZN207049H, PZN207051H thru PZN207308H, PZN207310H thru PZN207392H, PZN207394H thru PZN207420H, PZN207422H thru PZN207496H, PZN207498H thru PZN207537H, PZN207539H thru PZN207557H, PZN207559H thru PZN207837H, PZN207839H, PZN207840H, PZN207841H, PZN207842H, PZN207843H, PZN207844H, PZN207845H, PZN207846H, PZN207847H, PZN207849H thru PZN207877H, PZN207882H thru PZN207895H, PZN207897H, PZN207898H, PZN207901H, PZN207902H, PZN207903H, PZN207904H, PZN207906H, PZN207907H, PZN207908H, PZN207909H, PZN207910H, PZN207911H, PZN207912H, PZN207913H, PZN207914H, PZN207915H, PZN207916H, PZN207918H thru, PZN207938H, PZN207940H thru PZN208151H, PZN208153H, PZN208154H, PZN208155H, PZN208156H, PZN208157H, PZN208158H, PZN208159H, PZN208161H thru PZN208181H, PZN208183H thru PZN208225H, PZN208227H thru PZN208310H, PZN208312H thru PZN208391H, PZN208394H thru PZN208430H thru PZN208450H, PZN208452H thru PZN208531H, PZN208533H thru, PZN208631H, PZN208633H, PZN208634H, PZN600001S, PZN600003S, PZN600004S, PZN600005S, PZN600006S, PZN600048S thru PZN600120S, PZN600122S thru PZN600149S, PZN600151S thru PZN600173S, PZN600175S thru PZN600224S, PZN600226S, PZN600227S, PZN600228S, PZN600229S, PZN600230S, PZN600231S, PZN600232S, PZN600233S, PZN600235S thru PZN600286S, PZN600288S, PZN600289S, PZN600290S, PZN600291S, PZN600292S, PZN600293S, PZN600294S, PZN600295S, PZN600296S, PZN600297S, PZN600298S, PZN600299S, PZN600301S thru PZN600612S, PZN600614S thru PZN600633S, PZN600635S thru PZN600655S, PZN600657S, PZN600658S, PZN600659S, PZN600660S, PZN600661S, PZN600662S, PZN600663S, PZN600664S, PZN600665S, PZN600666S, PZN600667S, PZN600668S, PZN600669S, PZN600671S, PZN600672S, PZN600673S, PZN600674S, PZN600675S, PZN600676S, PZN600677S, PZN600678S, PZN600679S, PZN600680S, PZN600681S, PZN600682S, PZN600683S, PZN600685S, PZN600686S, PZN600687S, PZN600688S, PZN600689S, PZN600690S, PZN600691S, PZN600692S, PZN600693S, PZN600694S, PZN600695S, PZN600696S, PZN600697S, PZN600698S, PZN600700S, PZN600701S, PZN600702S, PZN600703S, PZN600704S, PZN600705S, PZN600706S, PZN600707S, PZN600708S, PZN600709S, PZN600710S, PZN600711S, PZN600712S, PZN600713S, PZN600714S, PZN600715S, PZN600716S, PZN600717S, PZN600718S, PZN600719S, PZN600720S, PZN600721S, PZN600722S, PZN600723S, PZN600724S, PZN600725S, PZN600726S, PZN600727S, PZN600729S thru PZN601006S, PZN601008S thru PZN601161S, PZN601163S thru PZN601206S, PZN601208S thru PZN601542S, PZN601544S thru PZN601568S, PZN601570S thru PZN601593S, PZN601595S thru PZN601610S, PZN601613S thru PZN601646S, PZN601648S thru PZN601739S, PZN601741S, PZN601742S, PZN601744S thru PZN601778S, PZN601780S thru PZN601822S, PZN601824S thru PZN602120S, PZN602122S, PZN602123S, PZN602124S, PZN602125S, PZN602126S, PZN602128S, PZN602129S, PZN602130S, PZN602131S, PZN602132S, PZN602134S thru PZN602549S, PZN602551S, PZN602552S thru PZN602728S, PZN602730S thru PZN602745S, PZN602747S thru PZN602781S, PZN602783S thru PZN602880S, PZN602882S thru PZN602907S, PZN602909S thru PZN603029S, PZN603031S thru PZN603085S, PZN603087S thru PZN603222S, PZN603224S thru PZN603243S, PZN603245S thru PZN603269S, PZN603271S thru PZN603374S, PZN603376S thru PZN603419S, PZN603421S thru PZN603475S, PZN603477S thru PZN603577S, PZN603579S thru PZN603696S, PZN603698S thru PZN603716S, PZN603718S thru PZN603786S, PZN603788S thru PZN603825S, PZN603827S thru PZN603867S, PZN603869S, PZN603870S, PZN603871S, PZN603872S, PZN603873S, PZN603875S thru PZN604070S, PZN604072S thru PZN604123S, PZN604125S thru PZN604139S, PZN604141S thru PZN604727S, PZN604729S thru PZN604973S, PZN604975S thru PZN604987S, PZN604989S thru PZN605316S, PZN605318S thru PZN605388S, PZN605390S, PZN605391S, PZN605392S, PZN605393S, PZN605395S, PZN605396S, PZN605397S, PZN605398S, PZN605399S, PZN605400S, PZN605402S, PZN605403S, PZN605404S, PZN605405S, PZN605406S, PZN605407S, PZN605408S, PZN605409S, PZN605410S, PZN605412S, PZN605413S, PZN605415S, PZN605417S thru PZN605518S, PZN605520S thru PZN605573S, PZN605575S thru PZN605657S, PZN605659S thru PZN605850S, PZN605852S thru PZN605905S, PZN605907S thru PZN606063S, PZN606065S thru PZN606085S, PZN606087S thru PZN606097S, PZN606099S, PZN606100S, PZN606102S, PZN606103S, PZN606104S, PZN606105S, PZN606106S, PZN606107S, PZN606108S, PZN606109S, PZN606110S, PZN606111S, PZN606112S, PZN606113S, PZN606115S thru PZN606185S, PZN606187S thru PZN606424S, PZN606426S thru PZN606448S, PZN606450S, PZN606451S, PZN606452S, PZN606453S, PZN606454S, PZN606455S, PZN606456S, PZN606458S, PZN606459S, PZN606460S, PZN606461S, PZN606462S, PZN606463S, PZN606464S, PZN606465S, PZN606466S, PZN606467S, PZN606468S, PZN606469S, PZN606470S, PZN606472S thru PZN606581S, PZN606583S thru PZN606597S, PZN606599S, PZN606600S, PZN606601S, PZN606602S, PZN606603S, PZN606604S, PZN606605S, PZN606606S, PZN606607S, PZN606608S, PZN606610S thru PZN606666S, PZN606668S, PZN606669S, PZN606670S, PZN606672S, PZN606673S, PZN606674S, PZN606675S, PZN606676S, PZN606677S, PZN606678S, PZN606679S, PZN606680S, PZN606681S, PZN606682S, PZN606683S, PZN606684S, PZN606685S, PZN606686S, PZN606687S, PZN606688S, PZN606689S, PZN606691S, PZN606692S, PZN606693S, PZN606694S, PZN606695S, PZN606696S, PZN606697S, PZN606698S, PZN606699S, PZN606700S, PZN606702S, PZN606703S, PZN606704S, PZN606705S, PZN606706S, PZN606707S, PZN606709S, PZN606710S, PZN606711S, PZN606712S, PZN606714S, PZN606715S, PZN606717S, PZN606718S, PZN606719S, PZN606720S, PZN606721S, PZN606722S, PZN606723S, PZN606725S thru PZN606745S, PZN606747S thru PZN606782S, PZN606784S thru PZN606837S, PZN606839S thru PZN606954S, PZN606956S, PZN606957S, PZN606958S, PZN606959S, PZN606960S, PZN606961S, PZN606962S, PZN606963S, PZN606964S, PZN606965S, PZN606966S, PZN606967S, PZN606968S, PZN606969S, PZN606970S, PZN606971S, PZN606972S, PZN606974S thru PZN607046S, PZN607048S, PZN607049S thru PZN607099S, PZN607101S thru PZN607157S, PZN607159S thru PZN607179S, PZN607181S thru PZN607197S, PZN607199S thru PZN607237S, PZN607239S, PZN607240S thru PZN607279S, PZN607281S thru PZN607377S, PZN607379S thru PZN607442S, PZN607444S thru PZN607517S, PZN607519S thru PZN607580S, PZN607582S, PZN607583S, PZN607584S, PZN607585S, PZN607586S, PZN607587S, PZN607588S, PZN607589S, PZN607590S, PZN607592S, PZN607593S, PZN607594S, PZN607595S, PZN607596S, PZN607597S, PZN607599S thru PZN607620S, PZN607622S thru PZN607683S, PZN607685S, PZN607687S thru PZN607737S, PZN607739S thru PZN607854S, PZN607856S thru PZN607907S, PZN607909S thru PZN607936S, PZN607939S thru PZN607960S, PZN607962Sthru PZN608056S, PZN608058S thru PZN608085S, PZN608087S thru PZN608123S, PZN608125S, PZN608126S, PZN608127S, PZN608128S, PZN608129S, PZN608130S, PZN608131S, PZN608132S, PZN608133S, PZN608134S, PZN608135S, PZN608136S, PZN608137S, PZN608138S, PZN608140S thru PZN608182S, PZN608184S thru PZN608522S, PZN608524S, PZN608525S, PZN608526S, PZN608527S, PZN608529S thru PZN608550S, PZN608553S thru PZN608605S, PZN608607S thru PZN608704S, PZN608706S, PZN608707S, PZN608708S, PZN608709S, PZN608711S thru PZN608801S, PZN608803S, PZN608804S, PZN608805S, PZN608806S, PZN608807S, PZN608808S, PZN608809S, PZN608814S thru PZN608851S, PZN608853S thru PZN608897S, PZN608899S thru PZN609034S, PZN609036S thru PZN609099S, PZN609101S thru PZN609166S, PZN609169S, PZN609170S, PZN609172S thru PZN609231S, PZN609233S thru PZN609363S, PZN609366S thru PZN609401S, PZN609403S thru PZN609434S, PZN609437S thru PZN609497S, PZN609499S thru PZN609558S,
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul, Minnesota 55112
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the u
FDA Determined
Cause 2
DESIGN: Software Design
Action Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected. For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
Quantity in Commerce 17834
Distribution Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Applicant = MEDTRONIC INC.
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