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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DualChamber External Temporary Pulse Generators Model 5388

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  Class 2 Device Recall Medtronic DualChamber External Temporary Pulse Generators Model 5388 see related information
Date Initiated by Firm October 11, 2010
Date Posted November 22, 2010
Recall Status1 Terminated 3 on May 29, 2012
Recall Number Z-0430-2011
Recall Event ID 57098
PMA Number P820003S072 
Product Classification Implantable pulse generator, pacemaker (non-crt) - Product Code LWP
Product Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA.
Code Information Serial numbers: PEG026278, PFG001362P, PFG001406P, PFG001755P, PFG001906P, PFG001918P, PFG002648P, PFG002911P, PFG002929P, PFG003371P, PFG003923P, PFG003932P, PFG003933P, PFG004462P, PFG005391P, PFG007169P, PFG008759P, PFG015326P, PFG01534P, PFG015449P, PFG017606P, PFG018062P, PFG018161P, PFG018176P, PFG018429P, PFG018475P, PFG020770P, PFG021284P, PFG021309P, PFG022541P, PFG022740P, PFG022864P, PFG022902P, PFG023043P, PFG023107P, PFG023108P, PFG023473P, PFG023518P, PFG023608P, PFG023933P, PFG023987P, PFG024002P, PFG025347P, PFG025736P, PFG025746P, PFG026378P, PFG028007P, PFG028350P, PFG028755P, PFG028986P, PFG029169P, PFG029173P, PFG029174P, PFG029175P, PFG029176P, PFG029177P, PFG029237P, PFG029603P, PFG029604P, PFG029808P, PFG029967P, PFG030425P, PFG030707P, PFG031194P, PFG031195P, PFG031197P, PFG031386P, PFG031538P, PFG031539P, PFG031540P, PFG031543P, PFG031789P, PFG031838P, PFG032089P, PFG032121P, PFG033136P, PFG033229P, PFG033266P, PFG033323P, PFG033537P, PFG033703P, PFG033791P, PFG034239P, PFG034732P thru PFG034769P, PFG034770P, PFG034771P, PFG034772P, PFG050100P thru PFG050137P, PFG050139P, PFG050140P, PFG050141P, PFG050142P, PFG050144P, PFG050146P thru PFG050162P, PFG050165P, PFG050166P, PFG050167P, PFG050168P, PFG050169P, PFG050170P, PFG050171P, PFG050172P, PFG050173P, PFG050175P, PFG050176P, PFG050177P, PFG050178P, PFG050179P, PFG050180P, PFG050182P, PFG050183P, PFG050184P, PFG050185P, PFG050186P, PFG050187P, PFG050188P, PFG050189P, PFG050191P thru PFG050243P, PFG050246P thru PFG050263P, PFG050266P, PFG050267P, PFG050269P, PFG050270P, PFG050271P, PFG050273P, PFG050274P, PFG050275P, PFG050277P, PFG050278P, PFG050279P, PFG050280P, PFG050281P, PFG050282P, PFG050283P, PFG050284P, PFG050285P, PFG050287P, PFG050288P, PFG050289P, PFG050290P, PFG050291P, PFG050292P, PFG050293P, PFG050294P, PFG050295P, PFG050296P, PFG050297P, PFG050298P, PFG050299P, PFG050300P, PFG050302P thru PFG050323P, PFG050325P thru PFG050367P, PFG050369P, PFG050370P, PFG050371P, PFG050372P, PFG050373P, PFG050374P, PFG050375P, PFG050376P, PFG050378P thru PFG050391P, PFG050393P, PFG050395P, PFG050397P, PFG050398P, PFG050399P, PFG050401P thru PFG050466P, PFG050468P thru PFG050524P, PFG050526P, PFG050528P, PFG050529P, PFG050530P, PFG050532P, PFG050533P, PFG050535P, PFG050538P thru PFG050555P, PFG050557P, PFG050558P, PFG050560P thru PFG050577P, PFG050579P, PFG050580P, PFG050582P, PFG050586P, PFG050587P, PFG050588P, PFG050589P, PFG050590P, PFG050592P, PFG050593P, PFG050594P, PFG050598P, PFG050599P, PFG050600P, PFG050601P, PFG050602P, PFG050603P, PFG050604P, PFG050605P, PFG050606P, PFG050607P, PFG050608P, PFG050609P, PFG050610P, PFG050611P, PFG050613P, PFG050614P, PFG050615P, PFG050617P thru PFG050653P, PFG050655P thru PFG050682P, PFG050684P, PFG050685P, PFG050686P, PFG050687P, PFG050688P, PFG050690P, PFG050693P, PFG050695P thru PFG050710P, PFG050712P, PFG050716P, PFG050717P, PFG050720P, PFG050721P, PFG050724P thru PFG050741P, PFG050746P, PFG050747P, PFG050748P, PFG050749P, PFG050750P, PFG050751P, PFG050753P thru PFG050763P, PFG050765P, PFG050767P, PFG050769P, PFG050770P, PFG050772P, PFG050775P, PFG050776P, PFG050777P, PFG050780P thru PFG050797P, PFG050800P thru PFG050887P, PFG050890P, PFG050891P, PFG050892P, PFG050893P, PFG050895P thru PFG050917P, PFG050919P thru PFG050931P, PFG050933P, PFG050935P, PFG050936P, PFG050937P, PFG050938P, PFG050940P, PFG050941P, PFG050942P, PFG050943P, PFG050945P thru PFG050963P, PFG050965P thru PFG050997P, PFG050999P, PFG051000P, PFG051001P, PFG051002P, PFG051003P, PFG051004P, PFG051005P, PFG051006P, PFG051007P, PFG051008P, PFG051009P, PFG051010P, PFG051012P thru PFG051043P, PFG051045P, PFG051046P, PFG051050P, PFG051051P, PFG051052P, PFG051053P, PFG051054P, PFG051055P, PFG051056P, PFG051057P, PFG051058P, PFG051060P thru PFG051083P, PFG051085P thru PFG051130P, PFG051133P thru PFG051144P, PFG051146P, PFG051148P thru PFG051178P, PFG051181P thru PFG051235P, PFG051237P thru PFG051288P, PFG051290P thru PFG051374P, PFG051376P thru PFG051445P, PFG051447P thru PFG051456P, PFG051458P thru PFG051475P, PFG051477P thru PFG051510P, PFG051512P thru PFG051532P, PFG051535P thru PFG051567P, PFG051569P, PFG051571P, PFG051573P thru PFG051611P, PFG051613P thru PFG051647P, PFG051649P, PFG051650P, PFG051651P, PFG051652P, PFG051653P, PFG051654P, PFG051655P, PFG051657P thru PFG051675P, PFG051677P thru PFG051691P, PFG051700P thru PFG051713P, PFG051715P, PFG051716P, PFG051717P, PFG051719P, PFG051721P thru PFG051787P, PFG051789P, PFG051791P, PFG051793P, PFG051795P, PFG051797P thru PFG051813P, PFG051815P, PFG051818P thru PFG051872P, PFG051874P thru PFG051906P, PFG051908P, PFG051909P, PFG051910P, PFG051911P, PFG051912P, PFG051915P, PFG051916P, PFG051917P, PFG051918P, PFG051919P, PFG051920P, PFG051921P, PFG051922P, PFG051923P, PFG051924P, PFG051925P, PFG051926P, PFG051928P, PFG051929P, PFG051930P, PFG051932P thru PFG051950P, PFG051952P, PFG051953P, PFG051958P, PFG051961P, PFG051962P, PFG051963P, PFG051964P, PFG051966P thru PFG052051P, PFG052054P, PFG052055P, PFG052056P, PFG052057P, PFG052058P, PFG052059P, PFG052061P, PFG052062P, PFG052063P, PFG052064P, PFG052065P, PFG052066P, PFG052067P, PFG052068P, PFG052069P, PFG052070P, PFG052071P, PFG052072P, PFG052073P, PFG052074P, PFG052076P thru PFG052171P, PFG052173P, PFG052175P thru PFG052203P, PFG052205P thru PFG052229P, PFG052232P, PFG052233P, PFG052235P, PFG052236P, PFG052237P, PFG052238P, PFG052241P, PFG052242P, PFG052243P, PFG052244P, PFG052245P, PFG052246P, PFG052247P, PFG052248P, PFG052249P, PFG052250P, PFG052251P, PFG052252P, PFG052254P thru PFG052273P, PFG052275P thru PFG052381P, PFG052383P, PFG052384P, PFG052385P, PFG052386P, PFG052387P, PFG052388P, PFG052389P, PFG052390P, PFG052392P, PFG052393P, PFG052394P, PFG052395P, PFG052396P, PFG052397P, PFG052398P, PFG052402P thru PFG052415P, PFG052417P, PFG052418P, PFG052419P, PFG052421P, PFG052422P, PFG052423P, PFG052424P, PFG052425P, PFG052426P, PFG052427P, PFG052428P, PFG052430P, PFG052431P, PFG052432P, PFG052433P, PFG052434P, PFG052435P, PFG052437P thru PFG052506P, PFG052508P, PFG052509P, PFG052511P thru PFG052599P, PFG052601P, PFG052603P, PFG052604P, PFG052605P, PFG052606P, PFG052607P, PFG052608P, PFG052609P, PFG052611P, PFG052612P, PFG052613P, PFG052614P, PFG052615P, PFG052616P, PFG052617P, PFG052618P, PFG052619P, PFG052620P, PFG052621P, PFG052622P, PFG052623P, PFG052624P, PFG052626P, PFG052627P, PFG052628P, PFG052629P, PFG052630P, PFG052631P, PFG052632P, PFG052634P, PFG052635P, PFG052636P, PFG052637P, PFG052640P thru PFG052684P, PFG052686P, PFG052687P, PFG052689P thru PFG052736P, PFG052739P, PFG052740P, PFG052741P, PFG052742P, PFG052744P thru PFG052770P, PFG052772P thru PFG052833P, PFG052835P thru PFG052855P, PFG052859P, PFG052860P, PFG052862P, PFG052864P, PFG052865P thru PFG052904P, PFG052907P thru PFG052952P, PFG052954P thru PFG052969P, PFG052971P thru PFG053006P, PFG053008P, PFG053009P, PFG053010P, PFG053011P, PFG053012P, PFG053013P, PFG053014P, PFG053017P thru PFG053083P, PFG053086P, PFG053087P, PFG053089P, PFG053090P, PFG053091P, PFG053092P, PFG053093P, PFG053094P, PFG053095P, PFG053096P, PFG053097P, PFG053098P, PFG053099P, PFG053100P, PFG053101P, PFG053102P, PFG053103P, PFG053104P, PFG053105P, PFG053106P, PFG053107P, PFG053108P, PFG053109P, PFG053111P thru PFG053133P, PFG053135P, PFG053136P, PFG053137P, PFG053138P, PFG053139P, PFG053140P, PFG053141P, PFG053142P, PFG053143P, PFG053144P, PFG053145P, PFG053146P, PFG053148P, PFG053149P, PFG053150P, PFG053151P, PFG053152P, PFG053153P, PFG053155P thru PFG053175P, PFG053177P, PFG053179P thru PFG053306P, PFG053308P thru PFG053326P, PFG053328P, PFG053329P, PFG053330P, PFG053331P, PFG053332P, PFG053333P, PFG053335P thru PFG053357P, PFG053362P thru PFG053392P, PFG053394P, PFG053395P, PFG053397P, PFG053398P, PFG053399P, PFG053401P, PFG053402P, PFG053403P, PFG053404P, PFG053406P, PFG053407P, PFG053408P, PFG053409P, PFG053410P, PFG053411P, PFG053413P thru PFG053448P, PFG053450P, PFG053451P, PFG053452P, PFG053453P, PFG053454P, PFG053455P.PFG053456P, PFG053457P, PFG053458P, PFG053459P, PFG053460P, PFG053461P, PFG053462P, PFG053464P thru PFG053485P, PFG053487P, PFG053488P, PFG053489P, PFG053490P, PFG053492P thru PFG053538P, PFG053540P thru PFG053570P, PFG053572P thru PFG053597P, PFG053600P, PFG053602P, PFG053603P, PFG053604P, PFG053605P, PFG053606P, PFG053607P, PFG053608P, PFG053609P, PFG053610P, PFG053612P, PFG053613P, PFG053614P, PFG053617P thru PFG053697P, PFG100003R, PFG100004R, PFG100005R, PFG100006R, PFG100008R, PFG100009R, PFG100011R, PFG100013R, PFG100014R, PFG100015R, PFG100016R, PFG100018R, PFG100020R, PFG100021R, PFG100022R, PFG100023R, PFG100024R, PFG100025R, PFG100027R, PFG100030R, PFG100031R, PFG100032R, PFG100033R, PFG100034R, PFG100035R, PFG100036R, PFG100037R, PFG100038R, PFG100039R, PFG100041R, PFG100043R, PFG100044R, PFG100045R, PFG100046R, PFG100047R, PFG100048R, PFG100049R, PFG100050R, PFG100051R, PFG100052R, PFG100053R, PFG100054R, PFG100056R, PFG100057R, PFG100058R, PFG100059R, PFG100060R, PFG100061R, PFG100062R, PFG100064R, PFG100066R, PFG100067R, PFG100068R, PFG100069R, PFG100070R, PFG100071R, PFG100072R, PFG100073R, PFG100075R, PFG100077R, PFG100078R, PFG100079R, PFG100080R, PFG100081R, PFG100082R, PFG100083R, PFG100084R, PFG100085R, PFG100087R, PFG100089R, PFG100091R, PFG100092R, PFG100093R, PFG100094R, PFG100097R, PFG100098R, PFG100099R, PFG100100R, PFG100101R, PFG100102R, PFG100103R, PFG100104R, PFG100106R, PFG100108R, PFG100109R, PFG100110R, PFG100111R, PFG100112R, PFG100113R, PFG100114R, PFG100115R, PFG100116R, PFG100117R, PFG100118R, PFG100119R, PFG100120R, PFG100122R, PFG100123R, PFG100124R, PFG100125R, PFG100127R, PFG100128R, PFG100130R, PFG100132R, PFG100133R, PFG100135R, PFG100136R, PFG100137R, PFG100138R, PFG100139R, PFG100140R, PFG100141R, PFG100142R, PFG100144R thru PFG100259R, PFG100261R, PFG100262R, PFG100263R, PFG100265R, PFG100266R, PFG100268R thru PFG100327R, PFG100329R, PFG100330R, PFG100331R, PFG100332R, PFG100334R thru PFG100367R, PFG100369R, PFG100370R, PFG100371R, PFG100372R, PFG100373R, PFG100374R, PFG100375R, PFG100377R, PFG100378R, PFG100379R, PFG100380R, PFG100381R, PFG100382R, PFG100384R thru PFG100410R, PFG100412R, PFG100413R, PFG100414R, PFG100415R, PFG100416R, PFG100417R, PFG100418R, PFG100421R, PFG100422R, PFG100424R, PFG100425R, PFG100426R, PFG100428R, PFG100429R, PFG100430R, PFG100432R, PFG100433R, PFG100434R, PFG100435R, PFG100436R, PFG100437R, PFG100438R, PFG100439R, PFG100440R, PFG100441R, PFG100442R, PFG100444R thru PFG100490R, PFG100492R thru PFG100511R, PFG100513R, PFG100514R, PFG100515R, PFG100516R, PFG100517R, PFG100518R, PFG100519R, PFG100520R, PFG100521R, PFG100522R, PFG100523R, PFG100524R, PFG100525R, PFG100526R, PFG100527R, PFG100529R, PFG100531R thru PFG100588R, PFG100590R thru PFG100625R, PFG100627R thru PFG100676R, PFG100678R, PFG100679R, PFG100680R thru PFG100807R, PFG100809R, PFG100810R, PFG100811R, PFG100812R, PFG100813R, PFG100814R, PFG100816R, PFG100817R, PFG100818R, PFG100819R, PFG100820R, PFG100821R, PFG100823R thru PFG100844R, PFG100847R thru PFG100871R, PFG100873R thru PFG100890R, PFG100892R, PFG100893R, PFG100895R, PFG100896R, PFG100897R, PFG100898R, PFG100899R, PFG100900R, PFG100901R thru PFG101019R, PFG101022R, PFG101024R thru PFG101058R, PFG101061R, PFG101062R, PFG101063R, PFG101064R, PFG101065R, PFG101066R, PFG101067R, PFG101068R, PFG101069R, PFG101070R, PFG101071R, PFG101072R, PFG101074R, PFG101076R, PFG101077R, PFG101080R, PFG101081R, PFG101082R, PFG101083R, PFG101084R, PFG101085R, PFG101086R, PFG101087R, PFG101088R, PFG101089R, PFG101090R, PFG101091R, PFG101093R, PFG101095R, PFG101096R, PFG101098R, PFG101101R thru PFG101182R, PFG101184R, PFG101185R, PFG101186R, PFG101187R, PFG101188R, PFG101189R, PFG101190R, PFG101191R, PFG101192R, PFG101193R, PFG101194R, PFG101195R, PFG101196R, PFG101197R, PFG101198R, PFG101199R, PFG101201R, PFG101202R, PFG101203R, PFG101204R, PFG101205R, PFG101207R thru PFG101241R, PFG101243R, PFG101245R thru PFG101292R, PFG101294R thru PFG101305R, PFG101307R, PFG101308R, PFG101309R, PFG101310R, PFG101311R, PFG101312R, PFG101313R, PFG101314R, PFG101315R, PFG101316R, PFG101319R, PFG101320R, PFG101323R, PFG101324R, PFG101325R, PFG101326R, PFG101327R, PFG101328R, PFG101329R, PFG101330R, PFG101331R, PFG101332R, PFG101333R, PFG101335R, PFG101336R, PFG101337R, PFG101338R, PFG101339R, PFG101341R, PFG101342R, PFG101343R, PFG101345R, PFG101346R, PFG101347R, PFG101348R, PFG101349R, PFG101350R, PFG101351R, PFG101353R, PFG101354R, PFG101355R, PFG101356R, PFG101357R, PFG101358R, PFG101360R, PFG101361R, PFG101362R, PFG101363R, PFG101364R, PFG101365R, PFG101366R, PFG101367R, PFG101368R, PFG101369R, PFG101370R, PFG101372R, PFG101374R thru PFG101393R, PFG101395R thru PFG101417R, PFG101420R thru PFG101435R, PFG101437R, PFG101438R, PFG101439R, PFG101440R, PFG101441R, PFG101442R, PFG101443R, PFG101444R, PFG101445R, PFG101447R thru PFG101535R, PFG101538R thru PFG101592R, PFG101594R, PFG101596R, PFG101598R, PFG101599R, PFG101601R, PFG101602R, PFG101603R, PFG101605R thru PFG101621R, PFG101623R, PFG101624R, PFG101626R, PFG101627R, PFG101629R, PFG101631R, PFG101632R, PFG101634R thru PFG101652R, PFG101654R, PFG101655R, PFG101656R, PFG101657R, PFG101658R, PFG101660R, PFG101661R, PFG101662R, PFG101663R, PFG101664R, PFG101665R, PFG101666R, PFG101667R, PFG101668R, PFG101669R, PFG101670R, PFG101672R, PFG101673R, PFG101674R, PFG101675R, PFG101676R, PFG101677R, PFG101678R, PFG101679R, PFG101680R, PFG101681R, PFG101682R, PFG101684R, PFG101685R, PFG101686R, PFG101687R, PFG101688R, PFG101689R, PFG101690R, PFG101691R, PFG101692R, PFG101693R, PFG101694R, PFG101696R thru PFG101719R, PFG101722R, PFG101723R, PFG101724R, PFG101725R, PFG101728R thru PFG101753R, PFG101755R, PFG101757R thru PFG101774R, PFG101776R thru PFG101864R, PFG101868R, PFG101869R, PFG101870R, PFG101871R, PFG101872R, PFG101873R, PFG101874R, PFG101875R, PFG101877R, PFG101878R, PFG101879R, PFG101880R, PFG101881R, PFG101882R, PFG101883R, PFG101884R, PFG101885R, PFG101886R, PFG101887R, PFG101888R, PFG101889R, PFG101890R, PFG101891R, PFG101893R, PFG101894R, PFG101895R, PFG101898R thru PFG101956R, PFG101958R thru PFG102033R, PFG102035R, PFG102036R, PFG102037R, PFG102038R, PFG102039R, PFG102040R, PFG102041R, PFG102043R, PFG102045R thru PFG102108R, PFG102110R, PFG102111R, PFG102112R, PFG102113R, PFG102114R, PFG102115R, PFG102176R thru PFG102232R, PFG102236R thru PFG102252R, PFG102257R, PFG102258R, PFG102259R, PFG102260R, PFG102261R, PFG102262R, PFG102272R thru PFG102291R, PFG102293R thru PFG102302R, PFG102304R, PFG102305R, PFG102306R, PFG102307R, PFG102308R, PFG102309R, PFG102310R, PFG102311R, PFG102312R, PFG102376R, PFG102378R, PFG102379R, PFG102380R, PFG102382R, PFG102383R, PFG102384R, PFG102385R,   EXPANDED: PFG001040P, PFG001186P, PFG001187P, PFG001229P, PFG001421P, PFG001697P, PFG001793P, PFG001829P, PFG001831P, PFG001841P, PFG001871P, PFG001874P, PFG001877P, PFG001885P, PFG001892P, PFG001893P, PFG001913P, PFG001915P, PFG001926P, PFG001946P, PFG001949P, PFG001950P, PFG001974P, PFG001978P, PFG001988P, PFG001989P, PFG001998P, PFG002001P, PFG002005P, PFG002025P, PFG002035P, PFG002037P, PFG002065P, PFG002080P, PFG002086P, PFG002100P, PFG002107P, PFG002108P, PFG002118P, PFG002119P, PFG002130P, PFG002136P, PFG002158P, PFG002182P, PFG002192P, PFG002227P, PFG002240P, PFG002255P, PFG002256P, PFG002265P, PFG002289P, PFG002309P, PFG002310P, PFG002311P, PFG002345P, PFG002369P, PFG002409P, PFG002411P, PFG002492P, PFG002536P, PFG002561P, PFG002592P, PFG002602P, PFG002638P, PFG002656P, PFG002659P, PFG002677P, PFG002697P, PFG002725P, PFG002732P, PFG002757P, PFG002765P, PFG002793P, PFG002801P, PFG002841P, PFG002842P, PFG002891P, PFG003042P, PFG003086P, PFG003134P, PFG003152P, PFG003167P, PFG003187P, PFG003214P, PFG003260P, PFG003322P, PFG003324P, PFG003402P, PFG003441P, PFG003443P, PFG003447P, PFG003451P, PFG003468P, PFG003485P, PFG003508P, PFG003542P, PFG003560P, PFG003567P, PFG003584P, PFG003585P, PFG003687P, PFG003707P, PFG003749P, PFG003750P, PFG003751P, PFG003782P, PFG003794P, PFG003915P, PFG003921P, PFG003944P, PFG003945P, PFG003959P, PFG003984P, PFG004016P, PFG004034P, PFG004038P, PFG004042P, PFG004063P, PFG004093P, PFG004101P, PFG004103P, PFG004113P, PFG004158P, PFG004174P, PFG004205P, PFG004206P, PFG004223P, PFG004257P, PFG004265P, PFG004266P, PFG004270P, PFG004288P, PFG004289P, PFG004295P, PFG004327P, PFG004331P, PFG004467P, PFG004499P, PFG004500P, PFG004501P, PFG004502P, PFG004535P, PFG004563P, PFG004595P, PFG004604P, PFG004622P, PFG004660P, PFG004668P, PFG004670P, PFG004685P, PFG004701P, PFG004708P, PFG004719P, PFG004738P, PFG004741P, PFG004754P, PFG004873P, PFG004895P, PFG004908P, PFG005058P, PFG005071P, PFG005109P, PFG005122P, PFG005126P, PFG005128P, PFG005130P, PFG005133P, PFG005143P, PFG005147P, PFG005158P, PFG005170P, PFG005180P, PFG005190P, PFG005206P, PFG005229P, PFG005266P, PFG005268P, PFG005278P, PFG005286P, PFG005429P, PFG005436P, PFG005458P, PFG005467P, PFG005478P, PFG005492P, PFG005499P, PFG005503P, PFG005509P, PFG005517P, PFG005520P, PFG005526P, PFG005694P, PFG005698P, PFG005749P, PFG005782P, PFG005870P, PFG005889P, PFG005891P, PFG005896P, PFG005916P, PFG005921P, PFG005927P, PFG005928P, PFG005932P, PFG005936P, PFG005939P, PFG005959P, PFG005960P, PFG005972P, PFG005973P, PFG006019P, PFG006065P, PFG006089P, PFG006098P, PFG006161P, PFG006257P, PFG006274P, PFG006278P, PFG006280P, PFG006285P, PFG006293P, PFG006300P, PFG006301P, PFG006302P, PFG006304P, PFG006308P, PFG006439P, PFG006504P, PFG006514P, PFG006547P, PFG006549P, PFG006572P, PFG006662P, PFG006664P, PFG006665P, PFG006695P, PFG006698P, PFG006719P, PFG006730P, PFG006760P, PFG006808P, PFG006838P, PFG006865P, PFG006879P, PFG006883P, PFG006964P, PFG006995P, PFG007094P, PFG007107P, PFG007121P, PFG007209P, PFG007227P, PFG007266P, PFG007278P, PFG007328P, PFG007349P, PFG007376P, PFG007407P, PFG007446P, PFG007450P, PFG007479P, PFG007490P, PFG007495P, PFG007506P, PFG007538P, PFG007573P, PFG007596P, PFG007627P, PFG007648P, PFG007653P, PFG007654P, PFG007698P, PFG007711P, PFG007758P, PFG007783P, PFG007858P, PFG007926P, PFG007933P, PFG007955P, PFG007967P, PFG007972P, PFG008024P, PFG008225P, PFG008321P, PFG008418P, PFG008435P, PFG008442P, PFG008599P, PFG008611P, PFG008726P, PFG008743P, PFG008808P, PFG008838P, PFG009004P, PFG009007P, PFG009057P, PFG009159P, PFG009175P, PFG009245P, PFG009280P, PFG009323P, PFG009335P, PFG009358P, PFG009417P, PFG009461P, PFG009476P, PFG009489P, PFG009545P, PFG009556P, PFG009565P, PFG009718P, PFG009774P, PFG009806P, PFG009814P, PFG009853P, PFG009859P, PFG009875P, PFG009926P, PFG009931P, PFG009935P, PFG009956P, PFG009969P, PFG010017P, PFG010027P, PFG010041P, PFG010098P, PFG010128P, PFG010146P, PFG010168P, PFG010196P, PFG010320P, PFG010430P, PFG010431P, PFG010437P, PFG010439P, PFG010696P, PFG010702P, PFG010703P, PFG010731P, PFG010879P, PFG010920P, PFG010921P, PFG010924P, PFG010936P, PFG010964P, PFG010974P, PFG010975P, PFG010977P, PFG011020P, PFG011239P, PFG011294P, PFG011300P, PFG011374P, PFG011438P, PFG011667P, PFG011727P, PFG011781P, PFG011968P, PFG012096P, PFG012288P, PFG012297P, PFG012309P, PFG012336P, PFG012405P, PFG012406P, PFG012465P, PFG012492P, PFG012502P, PFG012701P, PFG012728P, PFG012798P, PFG012809P, PFG012996P, PFG013028P, PFG013069P, PFG013071P, PFG013139P, PFG013193P, PFG013219P, PFG013275P, PFG013408P, PFG013454P, PFG013578P, PFG013845P, PFG013846P, PFG013960P, PFG013965P, PFG013975P, PFG014129P, PFG014182P, PFG014203P, PFG014331P, PFG014334P, PFG014405P, PFG014530P, PFG014546P, PFG014611P, PFG014891P, PFG014906P, PFG014964P, PFG014983P, PFG015068P, PFG015069P, PFG015072P, PFG015076P, PFG015140P, PFG015168P, PFG015272P, PFG015274P, PFG015397P, PFG015714P, PFG015729P, PFG015785P, PFG015889P, PFG015941P, PFG016000P, PFG016069P, PFG016242P, PFG016408P, PFG016419P, PFG016467P, PFG016655P, PFG016717P, PFG016816P, PFG017040P, PFG017042P, PFG017096P, PFG017126P, PFG017133P, PFG017222P, PFG017255P, PFG017266P, PFG017279P, PFG017304P, PFG017380P, PFG017481P, PFG017551P, PFG017583P, PFG017678P, PFG017692P, PFG017730P, PFG017837P, PFG017838P, PFG017841P, PFG018097P, PFG018101P, PFG018104P, PFG018106P, PFG018115P, PFG018118P, PFG018119P, PFG018120P, PFG018124P, PFG018268P, PFG018316P, PFG018324P, PFG018400P, PFG018736P, PFG018774P, PFG018800P, PFG018835P, PFG018887P, PFG019126P, PFG019179P, PFG019180P, PFG019319P, PFG019404P, PFG019429P, PFG019549P, PFG019552P, PFG019592P, PFG019698P, PFG019700P, PFG019800P, PFG019826P, PFG019846P, PFG020098P, PFG020288P, PFG020317P, PFG020347P, PFG020362P, PFG020419P, PFG020421P, PFG020428P, PFG020647P, PFG020682P, PFG020698P, PFG020714P, PFG020873P, PFG021028P, PFG021128P, PFG021131P, PFG021151P, PFG021183P, PFG021224P, PFG021247P, PFG021362P, PFG021424P, PFG021425P, PFG021471P, PFG021515P, PFG021557P, PFG021644P, PFG021689P, PFG021796P, PFG022037P, PFG022079P, PFG022349P, PFG022352P, PFG022381P, PFG022383P, PFG022446P, PFG022453P, PFG022521P, PFG022554P, PFG022608P, PFG022610P, PFG022611P, PFG022613P, PFG022784P, PFG022813P, PFG022826P, PFG022887P, PFG022972P, PFG023304P, PFG023424P, PFG023465P, PFG023580P, PFG023651P, PFG023714P, PFG023941P, PFG025034P, PFG025107P, PFG025221P, PFG025223P, PFG025297P, PFG025435P, PFG025440P, PFG025444P, PFG025447P, PFG025449P, PFG025631P, PFG025743P, PFG025747P, PFG025867P, PFG025868P, PFG025889P, PFG025899P, PFG026047P, PFG026058P, PFG026114P, PFG026138P, PFG026188P, PFG026196P, PFG026443P, PFG026700P, PFG026740P, PFG026794P, PFG026800P, PFG026804P, PFG026808P, PFG026813P, PFG026815P, PFG026836P, PFG026889P, PFG026995P, PFG027115P, PFG027151P, PFG027463P, PFG027734P, PFG027974P, PFG028116P, PFG028125P, PFG028170P, PFG028176P, PFG028211P, PFG028406P, PFG028429P, PFG028447P, PFG028451P, PFG028452P, PFG028807P, PFG029022P, PFG029035P, PFG029047P, PFG029285P, PFG029330P, PFG029388P, PFG029404P, PFG029431P, PFG029724P, PFG029794P, PFG030113P, PFG030226P, PFG030233P, PFG030532P, PFG030614P, PFG030630P, PFG030648P, PFG031015P, PFG031028P, PFG031054P, PFG031086P, PFG031914P, PFG031920P, PFG031921P, PFG031955P, PFG032041P, PFG032043P, PFG032055P, PFG032471P, PFG032555P, PFG032558P, PFG032635P, PFG032693P, PFG032776P, PFG032965P, PFG033022P, PFG033239P, PFG033466P, PFG033562P, PFG033959P, PFG034105P, PFG034204P, PFG034332P, PFG034442P, PFG034568P, PFG050138P, PFG050143P, PFG050145P, PFG050163P, PFG050164P, PFG050174P, PFG050181P, PFG050190P, PFG050244P, PFG050245P, PFG050264P, PFG050265P, PFG050268P, PFG050272P, PFG050276P, PFG050286P, PFG050301P, PFG050324P, PFG050368P, PFG050377P, PFG050392P, PFG050394P, PFG050396P, PFG050467P, PFG050525P, PFG050527P, PFG050531P, PFG050534P, PFG050536P, PFG050537P, PFG050556P, PFG050559P, PFG050578P, PFG050581P, PFG050583P, PFG050584P, PFG050585P, PFG050591P, PFG050595P, PFG050596P, PFG050597P, PFG050612P, PFG050616P, PFG050654P, PFG050683P, PFG050689P, PFG050691P, PFG050692P, PFG050694P, PFG050711P, PFG050713P, PFG050714P, PFG050715P, PFG050718P, PFG050719P, PFG050722P, PFG050723P, PFG050742P, PFG050743P, PFG050744P, PFG050745P, PFG050752P, PFG050764P, PFG050766P, PFG050768P, PFG050771P, PFG050773P, PFG050774P, PFG050778P, PFG050779P, PFG050798P, PFG050799P, PFG050888P, PFG050889P, PFG050894P, PFG050918P, PFG050932P, PFG050934P, PFG050939P, PFG050944P, PFG050998P, PFG051011P, PFG051044P, PFG051047P, PFG051048P, PFG051049P, PFG051059P, PFG051084P, PFG051131P, PFG051132P, PFG051145P, PFG051147P, PFG051179P, PFG051180P, PFG051236P, PFG051282P, PFG051283P, PFG051289P, PFG051375P, PFG051446P, PFG051457P, PFG051511P, PFG051533P, PFG051534P, PFG051568P, PFG051570P, PFG051572P, PFG051612P, PFG051648P, PFG051656P, PFG051676P, PFG051692P, PFG051714P, PFG051718P, PFG051720P, PFG051788P, PFG051790P, PFG051792P, PFG051794P, PFG051796P, PFG051814P, PFG051816P, PFG051817P, PFG051873P, PFG051907P, PFG051913P, PFG051914P, PFG051927P, PFG051931P, PFG051951P, PFG051954P, PFG051955P, PFG051956P, PFG051957P, PFG051959P, PFG051960P, PFG052052P, PFG052053P, PFG052060P, PFG052075P, PFG052172P, PFG052174P, PFG052204P, PFG052230P, PFG052231P.PFG052234P, PFG052239P, PFG052240P, PFG052253P, PFG052274P, PFG052382P, PFG052391P, PFG052399P, PFG052400P, PFG052401P, PFG052416P, PFG052420P, PFG052429P, PFG052436P, PFG052507P, PFG052510P, PFG052600P, PFG052602P, PFG052610P, PFG052625P, PFG052633P, PFG052638P, PFG052639P, PFG052685P, PFG052688P, PFG052737P, PFG052738P, PFG052743P, PFG052856P, PFG052857P, PFG052858P, PFG052861P, PFG052863P, PFG052905P, PFG052906P, PFG052953P, PFG053007P, PFG053015P, PFG053016P, PFG053084P, PFG053085P, PFG053088P, PFG053134P, PFG053147P, PFG053154P, PFG053307P, PFG053327P, PFG053358P, PFG053359P, PFG053360P, PFG053361P, PFG053393P, PFG053396P, PFG053400P, PFG053405P, PFG053412P, PFG053479P, PFG053483P, PFG053486P, PFG053491P, PFG053539P, PFG053571P, PFG053615P, PFG100002R, PFG100007R, PFG100010R, PFG100012R, PFG100017R, PFG100019R, PFG100026R, PFG100028R, PFG100029R, PFG100040R, PFG100042R, PFG100055R, PFG100063R, PFG100065R, PFG100074R, PFG100076R, PFG100086R, PFG100088R, PFG100090R, PFG100095R, PFG100096R, PFG100105R, PFG100107R, PFG100121R, PFG100126R, PFG100129R, PFG100134R, PFG100143R, PFG100260R, PFG100333R, PFG100357R, PFG100361R, PFG100368R, PFG100376R, PFG100383R, PFG100411R, PFG100419R, PFG100420R, PFG100423R, PFG100427R, PFG100431R, PFG100443R, PFG100491R, PFG100512R, PFG100528R, PFG100530R, PFG100589R, PFG100808R, PFG100815R, PFG100822R, PFG100845R, PFG100846R, PFG100872R, PFG100891R, PFG100894R, PFG100902R, PFG101020R, PFG101021R, PFG101023R, PFG101059R, PFG101060R, PFG101073R, PFG101075R, PFG101078R, PFG101079R, PFG101092R, PFG101094R, PFG101097R, PFG101099R, PFG101100R, PFG101183R, PFG101200R, PFG101206R, PFG101242R, PFG101244R, PFG101293R, PFG101306R, PFG101317R, PFG101318R, PFG101321R, PFG101322R, PFG101334R, PFG101344R, PFG101352R, PFG101359R, PFG101371R, PFG101373R, PFG101394R, PFG101418R, PFG101419R, PFG101436R, PFG101536R, PFG101537R, PFG101659R, PFG101671R, PFG101683R, PFG101695R, PFG101720R, PFG101721R, PFG101726R, PFG101727R, PFG101865R, PFG101866R, PFG101867R, PFG101876R, PFG101892R, PFG101896R, PFG101897R, PFG101957R.
Recalling Firm/
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact Instruments Technical Service
Manufacturer Reason
for Recall
A subset of Model 5388 Dual-Chamber External Temporary Pulse Generators worldwide may be unable to power up or may power down unexpectedly. The issue presents itself in one of two ways. First, during startup, and prior to initiating patient therapy, the instrument may power down in 1 - 2 seconds. Second, the instrument may power up correctly, but power down at a later time while in use.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Medtronic issued an Important Medical Device Correction letters, dated October 2010 and November 2010 to hospital's biomedical engineering department. The letter described the issue, how it presents, and stated that Medtronic will contact the hospitals to return affected product for servicing. The second letter reiterated that Medtronic would notify customers when FDA approves their design upgrade for returning devices for service. In the interim, hospitals should continue to use normally functioning devices. Cusotmers may contact Medtronic Instruments Technical Service at 800-638-1991 concerning this action.
Quantity in Commerce 5,595 ( 2,696 US, 2,899 OUS) EXPANDED: 944 (852 US, 92 OUS)
Distribution Worldwide Distribution: throughout USA and territories of Guam and Puerto Rico and to the countries of: Algeria, Argentina, Australia, Austria, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Guiana, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen NO ADDITIONAL COUNTRIES ARE AFFECTED BY THE EXPANSION.
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 = LWP and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT