| Class 2 Device Recall Soletra Implantable Neurostimulator | |
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/ Manufacturer |
Medtronic Neuromodulation 800 53rd Ave NE PO Box 1250 Minneapolis MN 55440-1250
|
For Additional Information Contact | 763-514-5174 |
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
|
|
|
|