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U.S. Department of Health and Human Services

Class 2 Device Recall Soletra Implantable Neurostimulator

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  Class 2 Device Recall Soletra Implantable Neurostimulator see related information
Date Initiated by Firm October 01, 2007
Date Posted February 05, 2008
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-0694-2008
Recall Event ID 45847
PMA Number P960009/S9 
Product Classification Neurostimulator - Product Code MHY
Product Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA (The Medtronic Activa System in an implantable, multiprogrammable quadripolar system that delivers electrical stimulation to selected areas of the brain)
Code Information NFW109187H, NFW109204H, NFW109214H, NFW109227H, NFW109228H, NFW109230H, NFW109249H, NFW109257H, NFW109268H, NFW109270H, NFW109271H, NFW109276H, NFW109289H, NFW109331H, NFW109333H, NFW109334H, NFW109338H, NFW109345H, NFW109368H, NFW109380H, NFW109384H, NFW109390H, NFW109393H, NFW109401H, NFW109404H, NFW109425H, NFW109426H, NFW109431H, NFW109432H, NFW109435H, NFW109437H, NFW109440H, NFW109442H, NFW109454H, NFW109459H, NFW109461H, NFW109482H, NFW109485H, NFW109487H, NFW109489H, NFW109501H, NFW109502H, NFW109503H, NFW109504H, NFW109505H, NFW109511H, NFW109513H, NFW109515H, NFW109528H, NFW109529H, NFW109532H, NFW109535H, NFW109540H, NFW109542H, NFW109545H, NFW109556H, NFW109557H, NFW109558H, NFW109562H, NFW109571H, NFW109575H, NFW109580H, NFW109581H, NFW109582H, NFW109584H, NFW109586H, NFW109597H, NFW109605H, NFW109610H, NFW109613H, NFW109618H, NFW109626H, NFW109627H, NFW109628H, NFW109632H, NFW109633H, NFW109640H, NFW109641H, NFW109644H, NFW109646H, NFW109647H, NFW109650H, NFW109653H, NFW109654H, NFW109657H, NFW109660H, NFW109663H, NFW109669H, NFW109673H, NFW109679H, NFW109681H, NFW109682H, NFW109683H, NFW109685H, NFW109690H, NFW109711H, NFW109715H, NFW109719H, NFW109727H, NFW109732H, NFW109741H, NFW109765H, NFW109766H, NFW109781H, NFW109786H, NFW109797H, NFW109803H, NFW109809H, NFW109811H, NFW109814H, NFW109821H, NFW109823H, NFW109826H, NFW109829H, NFW109830H, NFW109863H, NFW109896H, NFW109914H, NFW109917H, NFW109918H, NFW109922H, NFW109924H, NFW109927H, NFW109928H, NFW109931H, NFW109936H, NFW110108H, NFW110122H, NFW110800H, NFW110822H, NFW111722H, NFW111914H, NFW111961H, NFW111962H, NFW111963H, NFW111966H, NFW111970H, NFW112042H, NFW121803H, NFW121804H, NFW121805H, NFW121806H, NFW121807H, NFW121809H, NFW121810H, NFW121811H, NFW121812H, NFW121813H, NFW121814H, NFW121816H, NFW121817H, NFW121841H, NFW121844H, NFW121845H, NFW121846H, NFW121847H, NFW121848H, NFW121849H, NFW121851H, NFW121852H, NFW121853H, NFW121855H, NFW121857H, NFW121860H, NFW121862H, NFW121863H, NFW121864H, NFW121866H, NFW121868H, NFW121869H, NFW121870H, NFW121871H, NFW121872H, NFW121873H, NFW121875H, NFW121876H, NFW121877H, NFW121878H, NFW121879H, NFW121880H, NFW121881H, NFW121934H, NFW121935H, NFW121942H, NFW121948H, NFW121963H, NFW121964H, NFW121965H, NFW121967H, NFW121968H, NFW121969H, NFW121972H, NFW121973H, NFW121974H, NFW121975H, NFW121977H, NFW121978H, NFW121980H, NFW121981H, NFW121982H, NFW121984H, NFW121991H, NFW121992H, NFW121993H, NFW121994H, NFW121995H, NFW121996H, NFW121997H, NFW122001H, NFW122003H, NFW122004H, NFW122006H, NFW122007H, NFW122008H, NFW122009H, NFW122010H, NFW122012H, NFW122013H, NFW122016H, NFW122018H, NFW122020H, NFW122021H, NFW122022H, NFW122023H, NFW122025H, NFW122026H, NFW122027H, NFW122028H, NFW122029H, NFW122031H, NFW122032H, NFW122033H, NFW122034H, NFW122035H, NFW122039H, NFW122040H, NFW122041H, NFW122042H, NFW122045H, NFW122047H, NFW122048H, NFW122049H, NFW122050H, NFW122051H, NFW122052H, NFW122053H, NFW122055H, NFW122056H, NFW122057H, NFW122060H, NFW122061H, NFW122062H, NFW122063H, NFW122064H, NFW122066H, NFW122067H, NFW122069H, NFW122070H, NFW122071H, NFW122072H, NFW122073H, NFW122078H, NFW122079H, NFW122082H, NFW122083H, NFW122086H, NFW122087H, NFW122089H, NFW122090H, NFW122094H, NFW122095H, NFW122096H, NFW122097H, NFW122098H, NFW122099H, NFW122109H, NFW122115H, NFW122116H, NFW122117H, NFW122118H, NFW122119H, NFW122122H, NFW122124H, NFW122125H, NFW122126H, NFW122127H, NFW122128H, NFW122129H, NFW122130H, NFW122131H, NFW122132H, NFW122133H, NFW122134H, NFW122135H, NFW122136H, NFW122137H, NFW122138H, NFW122142H, NFW122143H, NFW122144H, NFW122145H, NFW122146H, NFW122152H, NFW122154H, NFW122155H, NFW122156H, NFW122158H, NFW122159H, NFW122160H, NFW122163H, NFW122165H, NFW122168H, NFW122169H, NFW122170H, NFW122171H, NFW122172H, NFW122173H, NFW122174H, NFW122175H, NFW122176H, NFW122177H, NFW122178H, NFW122179H, NFW122180H, NFW122181H, NFW122182H, NFW122183H, NFW122184H, NFW122185H, NFW122186H, NFW122188H, NFW122191H, NFW122194H, NFW122196H, NFW122198H, NFW122201H, NFW122202H, NFW122206H, NFW122208H, NFW122209H, NFW122210H, NFW122211H, NFW122212H, NFW122213H, NFW122215H, NFW122216H, NFW122217H, NFW122218H, NFW122220H, NFW122222H, NFW122224H, NFW122226H, NFW122228H, NFW122229H, NFW122230H, NFW122231H, NFW122232H, NFW122234H, NFW122235H, NFW122236H, NFW122237H, NFW122238H, NFW122239H, NFW122240H, NFW122241H, NFW122243H, NFW122244H, NFW122245H, NFW122247H, NFW122248H, NFW122249H, NFW122250H, NFW122251H, NFW122252H, NFW122254H, NFW122256H, NFW122257H, NFW122259H, NFW122260H, NFW122261H, NFW122262H, NFW122265H, NFW122266H, NFW122267H, NFW122268H, NFW122270H, NFW122273H, NFW122274H, NFW122276H, NFW122277H, NFW122280H, NFW122281H, NFW122282H, NFW122285H, NFW122287H, NFW122288H, NFW122290H, NFW122293H, NFW122295H, NFW122296H, NFW122297H, NFW122298H, NFW122299H, NFW122300H, NFW122301H, NFW122302H, NFW122303H, NFW122304H, NFW122306H, NFW122308H, NFW122309H, NFW122310H, NFW122311H, NFW122312H, NFW122314H, NFW122315H, NFW122316H, NFW122319H, NFW122320H, NFW122321H, NFW122325H, NFW122326H, NFW122327H, NFW122329H, NFW122330H, NFW122336H, NFW122339H, NFW122340H, NFW122343H, NFW122344H, NFW122345H, NFW122348H, NFW122349H, NFW122350H, NFW122352H, NFW122353H, NFW122354H, NFW122355H, NFW122356H, NFW122357H, NFW122361H, NFW122362H, NFW122363H, NFW122364H, NFW122365H, NFW122366H, NFW122367H, NFW122368H, NFW122369H, NFW122370H, NFW122371H, NFW122372H, NFW122373H, NFW122374H, NFW122376H, NFW122377H, NFW122378H, NFW122379H, NFW122380H, NFW122381H, NFW122383H, NFW122384H, NFW122385H, NFW122386H, NFW122388H, NFW122391H, NFW122398H, NFW122401H, NFW122403H, NFW122406H, NFW122413H, NFW122415H, NFW122416H, NFW122422H, NFW122424H, NFW122426H, NFW122427H, NFW122428H, NFW122432H, NFW122437H, NFW122442H, NFW122443H, NFW122446H, NFW122449H, NFW122476H, NFW122488H, NFW122493H, NFW122497H, NFW122499H, NFW122511H, NFW122519H, NFW122522H, NFW122525H, NFW122537H, NFW122541H, NFW122542H, NFW122543H, NFW122544H, NFW122546H, NFW122548H, NFW122549H, NFW122551H, NFW122555H, NFW122558H, NFW122559H, NFW122562H, NFW122566H, NFW122571H, NFW122572H, NFW122577H, NFW122583H, NFW122586H, NFW122587H, NFW122588H, NFW122589H, NFW122591H, NFW122593H, NFW122598H, NFW122599H, NFW122601H, NFW122602H, NFW122603H, NFW122605H, NFW122608H, NFW122609H, NFW122610H, NFW122611H, NFW122612H, NFW122613H, NFW122617H, NFW122618H, NFW122622H, NFW122623H, NFW122625H, NFW122630H, NFW122631H, NFW122632H, NFW122634H, NFW122727H, NFW122807H, NFW122811H, NFW122812H, NFW122814H, NFW122815H, NFW122816H, NFW122817H, NFW122823H, NFW122829H, NFW122831H, NFW122836H, NFW122837H, NFW122841H, NFW122844H, NFW122846H, NFW122871H, NFW122872H, NFW122874H, NFW122966H, NFW122969H, NFW122972H, NFW122975H, NFW122976H, NFW122981H, NFW122982H, NFW122983H, NFW122989H, NFW122992H, NFW122993H, NFW122994H, NFW122996H, NFW122998H, NFW123000H, NFW123001H, NFW123002H, NFW123003H, NFW123004H, NFW123005H, NFW123007H, NFW123008H, NFW123013H, NFW123015H, NFW123021H, NFW123022H, NFW123024H, NFW123026H, NFW123029H, NFW123030H, NFW123031H, NFW123033H, NFW123037H, NFW123040H, NFW123047H, NFW123049H, NFW123051H, NFW123053H, NFW123056H, NFW123057H, NFW123058H, NFW123059H, NFW123062H, NFW123063H, NFW123065H, NFW123066H, NFW123067H, NFW123069H, NFW123070H, NFW123071H, NFW123076H, NFW123081H, NFW123083H, NFW123084H, NFW123085H, NFW123090H, NFW123091H, NFW123093H, NFW123094H, NFW123098H, NFW123103H, NFW123105H, NFW123107H, NFW123111H, NFW123112H, NFW123114H, NFW123115H, NFW123118H, NFW123119H, NFW123120H, NFW123121H, NFW123122H, NFW123125H, NFW123126H, NFW123128H, NFW123129H, NFW123133H, NFW123134H, NFW123136H, NFW123137H, NFW123139H, NFW123140H, NFW123141H, NFW123142H, NFW123143H, NFW123144H, NFW123145H, NFW123146H, NFW123148H, NFW123152H, NFW123153H, NFW123154H, NFW123157H, NFW123158H, NFW123159H, NFW123161H, NFW123165H, NFW123170H, NFW123171H, NFW123173H, NFW123175H, NFW123176H, NFW123177H, NFW123180H, NFW123186H, NFW123187H, NFW123188H, NFW123189H, NFW123192H, NFW123197H, NFW123198H, NFW123204H, NFW123208H, NFW123212H, NFW123220H, NFW123221H, NFW123223H, NFW123225H, NFW123228H, NFW123230H, NFW123232H, NFW123233H, NFW123234H, NFW123235H, NFW123236H, NFW123237H, NFW123239H, NFW123240H, NFW123241H, NFW123242H, NFW123243H, NFW123244H, NFW123250H, NFW123251H, NFW123253H, NFW123254H, NFW123260H, NFW123261H, NFW123262H, NFW123264H, NFW123265H, NFW123266H, NFW123267H, NFW123268H, NFW123269H, NFW123270H, NFW123272H, NFW123277H, NFW123280H, NFW123281H, NFW123282H, NFW123283H, NFW123286H, NFW123287H, NFW123288H, NFW123289H, NFW123290H, NFW123292H, NFW123294H, NFW123295H, NFW123296H, NFW123298H, NFW123299H, NFW123300H, NFW123301H, NFW123302H, NFW123303H, NFW123304H, NFW123305H, NFW123311H, NFW123312H, NFW123314H, NFW123316H, NFW123317H, NFW123320H, NFW123322H, NFW123324H, NFW123329H, NFW123331H, NFW123332H, NFW123334H, NFW123335H, NFW123337H, NFW123339H, NFW123341H, NFW123342H, NFW123343H, NFW123344H, NFW123345H, NFW123346H, NFW123349H, NFW123350H, NFW123353H, NFW123354H, NFW123355H, NFW123358H, NFW123360H, NFW123361H, NFW123362H, NFW123363H, NFW123364H, NFW123365H, NFW123366H, NFW123367H, NFW123368H, NFW123369H, NFW123370H, NFW123371H, NFW123372H, NFW123373H, NFW123374H, NFW123376H, NFW123377H, NFW123378H, NFW123379H, NFW123380H, NFW123381H, NFW123382H, NFW123383H, NFW123384H, NFW123385H, NFW123386H, NFW123387H, NFW123388H, NFW123391H, NFW123392H, NFW123393H, NFW123395H, NFW123396H, NFW123397H, NFW123398H, NFW123399H, NFW123400H, NFW123401H, NFW123402H, NFW123403H, NFW123404H, NFW123405H, NFW123406H, NFW123407H, NFW123408H, NFW123409H, NFW123410H, NFW123411H, NFW123412H, NFW123413H, NFW123414H, NFW123415H, NFW123416H, NFW123417H, NFW123418H, NFW123419H, NFW123420H, NFW123421H, NFW123422H, NFW123423H, NFW123424H, NFW123425H, NFW123426H, NFW123427H, NFW123428H, NFW123429H, NFW123430H, NFW123431H, NFW123433H, NFW123434H, NFW123435H, NFW123436H, NFW123437H, NFW123438H, NFW123440H, NFW123441H, NFW123442H, NFW123443H, NFW123445H, NFW123447H, NFW123448H, NFW123450H, NFW123451H, NFW123455H, NFW123456H, NFW123458H, NFW123459H, NFW123460H, NFW123461H, NFW123462H, NFW123468H, NFW123470H, NFW123471H, NFW123471H, NFW123472H, NFW123476H, NFW123477H, NFW123478H, NFW123479H, NFW123481H, NFW123482H, NFW123483H, NFW123484H, NFW123485H, NFW123487H, NFW123488H, NFW123489H, NFW123490H, NFW123491H, NFW123494H, NFW123495H, NFW123499H, NFW123500H, NFW123502H, NFW123503H, NFW123504H, NFW123506H, NFW123508H, NFW123509H, NFW123510H, NFW123511H, NFW123512H, NFW123513H, NFW123514H, NFW123515H, NFW123517H, NFW123518H, NFW123519H, NFW123520H, NFW123521H, NFW123522H, NFW123525H, NFW123526H, NFW123527H, NFW123529H, NFW123530H, NFW123532H, NFW123533H, NFW123534H, NFW123535H, NFW123536H, NFW123537H, NFW123538H, NFW123539H, NFW123540H, NFW123542H, NFW123543H, NFW123544H, NFW123545H, NFW123546H, NFW123547H, NFW123551H, NFW123552H, NFW123554H, NFW123556H, NFW123558H, NFW123560H, NFW123561H, NFW123562H, NFW123563H, NFW123564H, NFW123565H, NFW123566H, NFW123567H, NFW123571H, NFW123572H, NFW123574H, NFW123575H, NFW123576H, NFW123578H, NFW123580H, NFW123583H, NFW123584H, NFW123585H, NFW123586H, NFW123587H, NFW123588H, NFW123589H, NFW123590H, NFW123591H, NFW123592H, NFW123596H, NFW123597H, NFW123599H, NFW123600H, NFW123601H, NFW123602H, NFW123603H, NFW123604H, NFW123607H, NFW123608H, NFW123609H, NFW123611H, NFW123614H, NFW123615H, NFW123616H, NFW123617H, NFW123618H, NFW123621H, NFW123623H, NFW123624H, NFW123626H, NFW123629H, NFW123630H, NFW123633H, NFW123634H, NFW123635H, NFW123636H, NFW123637H, NFW123638H, NFW123639H, NFW123640H, NFW123643H, NFW123644H, NFW123645H, NFW123649H, NFW123650H, NFW123651H, NFW123664H, NFW123668H, NFW123678H, NFW123681H, NFW123693H, NFW123697H, NFW123701H, NFW123709H, NFW123718H, NFW123725H, NFW123745H, NFW123751H, NFW123752H, NFW123759H, NFW123820H, NFW123825H, NFW123918H, NFW123935H, NFW123945H, NFW123948H, NFW123959H, NFW123983H, NFW123984H, NFW124032H, NFW124034H, NFW124075H, NFW124081H, NFW124086H, NFW124089H.NFW124092H, NFW124099H, NFW124105H, NFW124107H, NFW124192H, NFW124193H, NFW124198H, NFW124212H, NFW124223H, NFW124226H, NFW124597H, NFW125955H, NFW622374S, NFW622375S, NFW622376S, NFW622380S, NFW622381S, NFW622382S, NFW622383S, NFW622386S, NFW622392S, NFW622393S, NFW622416S, NFW622431S, NFW622434S, NFW622437S, NFW622440S, NFW622442S, NFW622446S, NFW622447S, NFW622448S, NFW622451S, NFW622455S, NFW622457S, NFW622459S, NFW622465S, NFW622467S, NFW622468S, NFW622471S, NFW622472S, NFW622475S, NFW622477S, NFW622478S, NFW622486S, NFW622501S, NFW622509S, NFW622510S, NFW622514S, NFW622517S, NFW622519S, NFW622523S, NFW622525S, NFW622527S, NFW622534S, NFW622536S, NFW622539S, NFW622545S, NFW622548S, NFW622553S, NFW622560S, NFW622561S, NFW622567S, NFW622569S, NFW622575S, NFW622586S, NFW622590S, NFW622591S, NFW622594S, NFW622595S, NFW622598S, NFW622601S, NFW622603S, NFW622604S, NFW622608S, NFW622610S, NFW622611S, NFW622614S, NFW622615S, NFW622620S, NFW622622S, NFW622623S, NFW622624S, NFW622632S, NFW622635S, NFW622639S, NFW622640S, NFW622641S, NFW622645S, NFW622648S, NFW622650S, NFW622651S, NFW622661S, NFW622664S, NFW622667S, NFW622668S, NFW622669S, NFW622671S, NFW622674S, NFW622679S, NFW622680S, NFW622681S, NFW622682S, NFW622683S, NFW622684S, NFW622690S, NFW622691S, NFW622693S, NFW622694S, NFW622697S, NFW622700S, NFW622704S, NFW622706S, NFW622707S, NFW622708S, NFW622709S, NFW622713S, NFW622715S, NFW622719S, NFW622720S, NFW622722S, NFW622723S, NFW622724S, NFW622725S, NFW622727S, NFW622732S, NFW622736S, NFW622741S, NFW622743S, NFW622747S, NFW622748S, NFW622752S, NFW622757S, NFW622759S, NFW622760S, NFW622782S, NFW622790S, NFW622895S, NFW622922S, NFW623134S, NFW623167S, NFW623201S, NFW623222S, NFW623434S, NFW623435S, NFW623436S, NFW623437S, NFW623439S, NFW623440S, NFW623442S, NFW623443S, NFW623444S, NFW623445S, NFW623446S, NFW623447S, NFW623448S, NFW623449S, NFW623451S, NFW623452S, NFW623453S, NFW623454S, NFW623456S, NFW623458S, NFW623464S, NFW623466S, NFW623469S, NFW623470S, NFW623474S, NFW623476S, NFW623478S, NFW623699S, NFW627968S, NFW628008S, NFW628009S, NFW628010S, NFW628011S, NFW628012S, NFW628013S, NFW628014S, NFW628017S, NFW628019S, NFW628020S, NFW628021S, NFW628023S, NFW628024S, NFW628025S, NFW628026S, NFW628027S, NFW628028S, NFW628029S, NFW628030S, NFW628031S, NFW628032S, NFW628034S, NFW628036S, NFW628037S, NFW628039S, NFW628040S, NFW628041S, NFW628042S, NFW628043S, NFW628044S, NFW628045S, NFW628046S, NFW628047S, NFW628048S, NFW628049S, NFW628050S, NFW628051S, NFW628052S, NFW628053S, NFW628054S, NFW628055S, NFW628056S, NFW628057S, NFW628060S, NFW628061S, NFW628062S, NFW628063S, NFW628064S, NFW628065S, NFW628066S, NFW628067S, NFW628068S, NFW628069S, NFW628070S, NFW628071S, NFW628072S, NFW628073S, NFW628075S, NFW628076S, NFW628078S, NFW628079S, NFW628080S, NFW628082S, NFW628083S, NFW628084S, NFW628086S, NFW628087S, NFW628089S, NFW628090S, NFW628091S, NFW628092S, NFW628093S, NFW628094S, NFW628095S, NFW628096S, NFW628098S, NFW628099S, NFW628101S, NFW628102S, NFW628103S, NFW628104S, NFW628106S, NFW628107S, NFW628108S, NFW628109S, NFW628110S, NFW628111S, NFW628112S, NFW628113S, NFW628115S, NFW628116S, NFW628117S, NFW628118S, NFW628119S, NFW628120S, NFW628121S, NFW628122S, NFW628123S, NFW628124S, NFW628125S, NFW628126S, NFW628127S, NFW628128S, NFW628129S, NFW628130S, NFW628131S, NFW628132S, NFW628133S, NFW628134S, NFW628135S, NFW628136S, NFW628137S, NFW628138S, NFW628139S, NFW628140S, NFW628141S, NFW628143S, NFW628144S, NFW628146S, NFW628147S, NFW628148S, NFW628149S, NFW628150S, NFW628151S, NFW628152S, NFW628153S, NFW628154S, NFW628155S, NFW628156S, NFW628157S, NFW628158S, NFW628159S, NFW628160S, NFW628161S, NFW628162S, NFW628163S, NFW628165S, NFW628166S, NFW628167S, NFW628168S, NFW628169S, NFW628170S, NFW628171S, NFW628172S, NFW628173S, NFW628174S, NFW628175S, NFW628176S, NFW628177S, NFW628178S, NFW628179S, NFW628180S, NFW628181S, NFW628182S, NFW628183S, NFW628184S, NFW628185S, NFW628186S, NFW628188S, NFW628190S, NFW628191S, NFW628192S, NFW628193S, NFW628194S, NFW628195S, NFW628196S, NFW628197S, NFW628198S, NFW628199S, NFW628200S, NFW628201S, NFW628203S, NFW628204S, NFW628205S, NFW628206S, NFW628207S, NFW628208S, NFW628209S, NFW628210S, NFW628211S, NFW628212S, NFW628213S, NFW628214S, NFW628215S, NFW628216S, NFW628217S, NFW628218S, NFW628219S, NFW628220S, NFW628221S, NFW628222S, NFW628223S, NFW628224S, NFW628225S, NFW628226S, NFW628228S, NFW628229S, NFW628231S, NFW628232S, NFW628233S, NFW628234S, NFW628235S, NFW628236S, NFW628237S, NFW628238S, NFW628239S, NFW628240S, NFW628241S, NFW628242S, NFW628243S, NFW628244S, NFW628245S, NFW628247S, NFW628248S, NFW628249S, NFW628250S, NFW628251S, NFW628252S, NFW628253S, NFW628254S, NFW628256S, NFW628257S, NFW628258S, NFW628259S, NFW628260S, NFW628261S, NFW628262S, NFW628263S, NFW628264S, NFW628265S, NFW628266S, NFW628267S, NFW628268S, NFW628269S, NFW628270S, NFW628271S, NFW628272S, NFW628273S, NFW628274S, NFW628275S, NFW628276S, NFW628277S, NFW628278S, NFW628279S, NFW628280S, NFW628281S, NFW628282S, NFW628283S, NFW628284S, NFW628285S, NFW628286S, NFW628287S, NFW628289S, NFW628290S, NFW628291S, NFW628292S, NFW628293S, NFW628294S, NFW628295S, NFW628296S, NFW628297S, NFW628298S, NFW628299S, NFW628300S, NFW628301S, NFW628302S, NFW628303S, NFW628304S, NFW628305S, NFW628306S, NFW628307S, NFW628308S, NFW628309S, NFW628310S, NFW628311S, NFW628312S, NFW628313S, NFW628314S, NFW628315S, NFW628316S, NFW628317S, NFW628318S, NFW628319S, NFW628320S, NFW628321S, NFW628322S, NFW628324S, NFW628325S, NFW628326S, NFW628327S, NFW628328S, NFW628329S, NFW628330S, NFW628331S, NFW628332S, NFW628333S, NFW628334S, NFW628335S, NFW628336S, NFW628337S, NFW628338S, NFW628339S, NFW628340S, NFW628341S, NFW628342S, NFW628343S, NFW628344S, NFW628345S, NFW628346S, NFW628347S, NFW628348S, NFW628349S, NFW628350S, NFW628351S, NFW628352S, NFW628353S, NFW628354S, NFW628355S, NFW628356S, NFW628357S, NFW628358S, NFW628359S, NFW628360S, NFW628361S, NFW628362S, NFW628363S, NFW628364S, NFW628366S, NFW628367S, NFW628368S, NFW628369S, NFW628370S, NFW628371S, NFW628372S, NFW628373S, NFW628374S, NFW628375S, NFW628376S, NFW628377S, NFW628378S, NFW628379S, NFW628380S, NFW628381S, NFW628382S, NFW628383S, NFW628384S, NFW628386S, NFW628387S, NFW628388S, NFW628389S, NFW628390S, NFW628391S, NFW628392S, NFW628393S, NFW628394S, NFW628395S, NFW628396S, NFW628397S, NFW628398S, NFW628399S, NFW628400S, NFW628401S, NFW628402S, NFW628403S, NFW628404S, NFW628405S, NFW628406S, NFW628407S, NFW628408S, NFW628409S, NFW628410S, NFW628411S, NFW628412S, NFW628413S, NFW628414S, NFW628415S, NFW628416S, NFW628417S, NFW628418S, NFW628419S, NFW628430S, NFW628434S, NFW628435S, NFW628440S, NFW628444S, NFW628446S, NFW628455S, NFW628467S, NFW628476S, NFW628493S, NFW628495S, NFW628496S, NFW628499S, NFW628503S, NFW628508S, NFW628510S, NFW628512S, NFW628516S, NFW628517S, NFW628522S, NFW628527S, NFW628529S, NFW628530S, NFW628531S, NFW628535S, NFW628540S, NFW628541S, NFW628542S, NFW628543S, NFW628544S, NFW628545S, NFW628546S, NFW628547S, NFW628548S, NFW628549S, NFW628550S, NFW628551S, NFW628552S, NFW628553S, NFW628554S, NFW628555S, NFW628556S, NFW628557S, NFW628558S, NFW628559S, NFW628560S, NFW628561S, NFW628562S, NFW628563S, NFW628564S, NFW628565S, NFW628566S, NFW628567S, NFW628568S, NFW628569S, NFW628570S, NFW628571S, NFW628572S, NFW628573S, NFW628574S, NFW628575S, NFW628576S, NFW628577S, NFW628578S, NFW628579S, NFW628580S, NFW628581S, NFW628582S, NFW628583S, NFW628584S, NFW628585S, NFW628586S, NFW628587S, NFW628588S, NFW628589S, NFW628594S, NFW628599S, NFW628600S, NFW628601S, NFW628604S, NFW628606S, NFW628614S, NFW628625S, NFW628633S, NFW628635S, NFW628636S, NFW628637S, NFW628638S, NFW628639S, NFW628646S, NFW628647S, NFW628649S, NFW628650S, NFW628651S, NFW628653S, NFW628654S, NFW628667S, NFW628668S, NFW628670S, NFW628693S, and NFW629539S.
Recalling Firm/
Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
Manufacturer Reason
for Recall
Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.
FDA Determined
Cause 2
Packaging change control
Action A letter "Medtronic Urgent: Device Recall" dated October 2007 was sent to Healthcare Professionals. The letter described the device defect, product involved, root cause, probability of occurrence, recommendations and also provided information for assistance. At the time of the recall all of the product remaining in date for use (not expired) had been implanted, therefore Medtronic provided Important Patient Management Information for the implanting physicians to use in patient care and decisions regarding patient explants.
Quantity in Commerce 1,652
Distribution Worldwide: USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, WA, WI, WY, UT, VA, VT, and WV and countries of Australia , Austria , Belgium , Canada , Cyprus , Czech Republic , Denmark , Finland , France , Germany , Greece , Hong Kong , Hungary , Iceland , India , Iran , Israel , Italy , Japan , Latin America, Lebanon , The Netherlands , Norway , Poland , Portugal , Russian Federation , Saudi Arabia , South Africa , Spain , Sweden , Switzerland , Turkey , and The 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MHY and Original Applicant = MEDTRONIC Inc.