Events

Recall of Device Recall Medtronic Model 53401 Single Chamber External Pulse Generator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    80267
  • Event Risk Class
    Class 2
  • Event Number
    Z-2317-2018
  • Event Initiated Date
    2018-06-06
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165007
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pulse-generator, pacemaker, external - Product Code DTE
  • Reason
    A subset of medtronic model 53401 single chamber external pulse generators (epgs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected power on reset (por).
  • Action
    Medtronic began notifying customers, via letter, on about 06/06/2018. Customers were instructed to verify if they possessed affected 53401 EPGs, if they did have affected EPGs to determine if the firmware was updated, to notify all appropriate personnel, to notify customers if the affected devices have been transferred, and to complete and return the Customer Confirmation Certificate. Instructions for determining if the EPG firmware has been updated include: 1) powering the unit on and viewing firmware version; 2) if the firmware version is 01.03.00 or greater, the EPG firmware has been updated with the correction; and 3) if firmware version is 01.02.00, the EPG firmware has not been updated. Medtronic requests that customers arrange to have their EPGs returned for the firmware update.

Device

Device Recall Medtronic Model 53401 Single Chamber External Pulse Generator
  • Model / Serial
    Serial Numbers MDB01005EP, MDB01006EP, MDB01007EP, MDB01008EP, MDB01009EP, MDB01010EP, MDB01011EP, MDB01012EP, MDB01013EP, MDB01014EP, MDB01015EP, MDB01016EP, MDB01017EP, MDB01018EP, MDB01019EP, MDB01036EP, MDB01037EP, MDB01038EP, MDB01039EP, MDB01040EP, MDB01041EP, MDB01042EP, MDB01043EP, MDB01044EP, MDB01045EP, MDB01046EP, MDB01047EP, MDB01048EP, MDB01049EP,  MDB01050EP, MDB01051EP, MDB01052EP, MDB01053EP, MDB01054EP, MDB01055EP, MDB01056EP, MDB01057EP, MDB01058EP, MDB01060EP, MDB01061EP, MDB01062EP, MDB01063EP, MDB01064EP, MDB01065EP, MDB01066EP, MDB01067EP, MDB01068EP, MDB01069EP, MDB01070EP, MDB01071EP, MDB01072EP, MDB01073EP, MDB01074EP, MDB01075EP, MDB01076EP, MDB01077EP, MDB01078EP, MDB01079EP, MDB01080EP, MDB01081EP, MDB01082EP, MDB01083EP, MDB01084EP, MDB01085EP, MDB01086EP, MDB01087EP, MDB01088EP, MDB01089EP, MDB01090EP, MDB01091EP, MDB01092EP, MDB01093EP, MDB01094EP, MDB01095EP, MDB01096EP, MDB01097EP, MDB01098EP, MDB01099EP, MDB01100EP, MDB01101EP, MDB01102EP, MDB01103EP, MDB01104EP, MDB01105EP, MDB01106EP, MDB01107EP, MDB01108EP, MDB01109EP, MDB01110EP, MDB01111EP, MDB01112EP, MDB01113EP, MDB01114EP, MDB01115EP, MDB01116EP, MDB01117EP, MDB01118EP, MDB01119EP, MDB01120EP, MDB01121EP, MDB01122EP, MDB01123EP, MDB01124EP, MDB01125EP, MDB01126EP, MDB01127EP, MDB01128EP, MDB01129EP, MDB01130EP, MDB01131EP, MDB01132EP, MDB01133EP, MDB01134EP, MDB01135EP, MDB01177EP, MDB01178EP, MDB01179EP, MDB01180EP, MDB01181EP, MDB01182EP, MDB01183EP, MDB01184EP, MDB01185EP, MDB01186EP, MDB01187EP, MDB01188EP, MDB01189EP, MDB01190EP, MDB01191EP, MDB01192EP, MDB01193EP, MDB01194EP, MDB01195EP, MDB01196EP, MDB01197EP, MDB01198EP, MDB01199EP, MDB01200EP, MDB01201EP, MDB01202EP, MDB01203EP, MDB01204EP, MDB01205EP, MDB01206EP, MDB01207EP, MDB01208EP, MDB01209EP, MDB01210EP, MDB01211EP, MDB01212EP, MDB01213EP, MDB01214EP, MDB01215EP, MDB01216EP, MDB01217EP, MDB01218EP, MDB01219EP, MDB01220EP, MDB01221EP, MDB01222EP, MDB01223EP, MDB01224EP, MDB01225EP, MDB01226EP, MDB01227EP, MDB01228EP, MDB01229EP, MDB01230EP, MDB01231EP, MDB01232EP, MDB01233EP, MDB01234EP, MDB01235EP, MDB01236EP, MDB01237EP, MDB01238EP, MDB01239EP, MDB01240EP, MDB01241EP, MDB01242EP, MDB01243EP, MDB01244EP, MDB01245EP, MDB01246EP, MDB01247EP, MDB01248EP, MDB01249EP, MDB01250EP, MDB01251EP, MDB01252EP, MDB01253EP, MDB01254EP, MDB01255EP, MDB01256EP, MDB01257EP, MDB01258EP, MDB01259EP, MDB01260EP, MDB01261EP, MDB01262EP, MDB01263EP, MDB01264EP, MDB01265EP, MDB01266EP, MDB01267EP, MDB01268EP, MDB01269EP, MDB01270EP, MDB01271EP, MDB01272EP, MDB01273EP, MDB01274EP, MDB01275EP, MDB01276EP, MDB01381EP, MDB01382EP, MDB01383EP, MDB01384EP, MDB01385EP, MDB01386EP, MDB01387EP, MDB01388EP, MDB01389EP, MDB01390EP, MDB01391EP, MDB01392EP, MDB01393EP, MDB01394EP, MDB01395EP, MDB01396EP, MDB02001EP, MDB02002EP, MDB02003EP, MDB02004EP, MDB02005EP, MDB02006EP, MDB02007EP, MDB02008EP, MDB02009EP, MDB02010EP, MDB02011EP, MDB02012EP, MDB02013EP, MDB02014EP, MDB02015EP, MDB02016EP, MDB02017EP, MDB02018EP, MDB02019EP, MDB02021EP, MDB02022EP, MDB02023EP, MDB02024EP, MDB02025EP, MDB02026EP, MDB02027EP, MDB02031EP, MDB02032EP, MDB02033EP, MDB02034EP, MDB02035EP, MDB02036EP, MDB02038EP, MDB02039EP, MDB02041EP, MDB02043EP, MDB02044EP, MDB02045EP, MDB02046EP, MDB02049EP, MDB02050EP, MDB02051EP, MDB02054EP, MDB02055EP, MDB02056EP, MDB02057EP, MDB02060EP, MDB02061EP, MDB02062EP, MDB02063EP, MDB02064EP, MDB02065EP, MDB02066EP, MDB02067EP, MDB02068EP, MDB02069EP, MDB02070EP, MDB02071EP, MDB02072EP, MDB02074EP, MDB02075EP, MDB02076EP, MDB02077EP, MDB02078EP, MDB02079EP, MDB02080EP, MDB02081EP, MDB02082EP, MDB02083EP, MDB02084EP, MDB02085EP, MDB02086EP, MDB02087EP, MDB02088EP, MDB02089EP, MDB02090EP, MDB02091EP, MDB02093EP, MDB02094EP, MDB02095EP, MDB02096EP, MDB02097EP, MDB02098EP, MDB02099EP, MDB02100EP, MDB02101EP, MDB02102EP, MDB02103EP, MDB02104EP, MDB02105EP, MDB02106EP, MDB02107EP, MDB02108EP, MDB02109EP, MDB02110EP, MDB02111EP, MDB02185EP, MDB02186EP, MDB02188EP, MDB02189EP, MDB02190EP, MDB02191EP, MDB02192EP, MDB02193EP, MDB02194EP, MDB02195EP, MDB02196EP, MDB02197EP, MDB02198EP, MDB02199EP, MDB02200EP, MDB02201EP, MDB02202EP, MDB02203EP, MDB02204EP, MDB02205EP, MDB02206EP, MDB02207EP, MDB02209EP, MDB02210EP, MDB02211EP, MDB02212EP, MDB02213EP, MDB02214EP, MDB02215EP, MDB02216EP, MDB02217EP, MDB02218EP, MDB02219EP, MDB02220EP, MDB02221EP, MDB02222EP, MDB02223EP, MDB02224EP, MDB02225EP, MDB02226EP, MDB02227EP, MDB02228EP, MDB02229EP, MDB02230EP, MDB02231EP, MDB02232EP, MDB02233EP, MDB02234EP, MDB02235EP, MDB02236EP, MDB02237EP, MDB02238EP, MDB02239EP, MDB02240EP, MDB02241EP, MDB02242EP, MDB02243EP, MDB02244EP, MDB02315EP, MDB02316EP, MDB02317EP, MDB02318EP, MDB02319EP, MDB02320EP, MDB02321EP, MDB02322EP, MDB02323EP, MDB02324EP, MDB02325EP, MDB02326EP, MDB02327EP, MDB02329EP, MDB02330EP, MDB02331EP, MDB02332EP, MDB02333EP, MDB02334EP, MDB02335EP, MDB02336EP, MDB02338EP, MDB02339EP, MDB02340EP, MDB02341EP, MDB02342EP, MDB02343EP, MDB02344EP, MDB02346EP, MDB02347EP, MDB02349EP, MDB02350EP, MDB02351EP, MDB02352EP, MDB02600EP, MDB02601EP, MDB02602EP, MDB02603EP, MDB02605EP, MDB02606EP, MDB02607EP, MDB02608EP, MDB02609EP, MDB02610EP, MDB02611EP, MDB02612EP, MDB02613EP, MDB02614EP, MDB02615EP, MDB02616EP, MDB02617EP, MDB02618EP, MDB02619EP, MDB02620EP, MDB02622EP, MDB02623EP, MDB02624EP, MDB02625EP, MDB02626EP, MDB02627EP, MDB02628EP, MDB02632EP, MDB02633EP, MDB02634EP, MDB02635EP, MDB02636EP, MDB02637EP, MDB02638EP, MDB02640EP, MDB02641EP, MDB02642EP, MDB02643EP, MDB02644EP, MDB02645EP, MDB02646EP, MDB02647EP, MDB02649EP, MDB02650EP, MDB02651EP, MDB02652EP, MDB02653EP, MDB02654EP, MDB02655EP, MDB02656EP, MDB02657EP, MDB02659EP, MDB02661EP, MDB02662EP, MDB02663EP, MDB02664EP, MDB02665EP, MDB02670EP, MDB02671EP, MDB02672EP, MDB02673EP, MDB02674EP, MDB02675EP, MDB02676EP, MDB02677EP, MDB02678EP, MDB02679EP, MDB02680EP, MDB02681EP, MDB02683EP, MDB02684EP, MDB02685EP, MDB02686EP, MDB02687EP, MDB02688EP, MDB02689EP, MDB02700EP, MDB02701EP, MDB02702EP, MDB02703EP, MDB02704EP, MDB02705EP, MDB02706EP, MDB02707EP, MDB02708EP, MDB02709EP, MDB02710EP, MDB02711EP, MDB02712EP, MDB02714EP, MDB02715EP, MDB02716EP, MDB02717EP, MDB02718EP, MDB02719EP, MDB02763EP, MDB02764EP, MDB02765EP, MDB02766EP, MDB02767EP, MDB02768EP, MDB02769EP, MDB02817EP, MDB02818EP, MDB02819EP, MDB02820EP, MDB02821EP, MDB02822EP, MDB02823EP, MDB02824EP, MDB02825EP, MDB02826EP, MDB02827EP, MDB02828EP, MDB02829EP, MDB02831EP, MDB02832EP, MDB02833EP, MDB02834EP, MDB02835EP, MDB02836EP, MDB02837EP, MDB02838EP, MDB02839EP, MDB02840EP, MDB02842EP, MDB02843EP, MDB02845EP, MDB02846EP, MDB02847EP, MDB02848EP, MDB02849EP, MDB02851EP, MDB02852EP, MDB02853EP, MDB02854EP, MDB02855EP, MDB02856EP, MDB02857EP, MDB02858EP, MDB02859EP, MDB02860EP, MDB02861EP, MDB02862EP, MDB02863EP, MDB02864EP, MDB02865EP, MDB02866EP, MDB02867EP, MDB02868EP, MDB02869EP, MDB02870EP, MDB02871EP, MDB02872EP, MDB02873EP, MDB02874EP, MDB02875EP, MDB02876EP, MDB02877EP, MDB02879EP, MDB02880EP, MDB02881EP, MDB02882EP, MDB02883EP, MDB02884EP, MDB02885EP, MDB02886EP, MDB02897EP, MDB02898EP, MDB02899EP, MDB02900EP, MDB02902EP, MDB02903EP, MDB02904EP, MDB02905EP, MDB02906EP, MDB02989EP, MDB02990EP, MDB02991EP, MDB02993EP, MDB02994EP, MDB02995EP, MDB02996EP, MDB02997EP, MDB02998EP, MDB02999EP, MDB03000EP, MDB03001EP, MDB03002EP, MDB03003EP, MDB03004EP, MDB03005EP, MDB03007EP, MDB03008EP, MDB03009EP, MDB03010EP, MDB03011EP, MDB03012EP, MDB03013EP, MDB03014EP, MDB03015EP, MDB03017EP, MDB03018EP, MDB03019EP, MDB03020EP, MDB03021EP, MDB03022EP, MDB03023EP, MDB03024EP, MDB03025EP, MDB03026EP, MDB03027EP, MDB03028EP, MDB03029EP, MDB03031EP, MDB03032EP, MDB03033EP, MDB03034EP, MDB03036EP, MDB03037EP, MDB03038EP, MDB03040EP, MDB03041EP, MDB03042EP, MDB03043EP, MDB03044EP, MDB03045EP, MDB03046EP, MDB03047EP, MDB03048EP, MDB03049EP, MDB03050EP, MDB03051EP, MDB03052EP, MDB03053EP, MDB03054EP, MDB03055EP, MDB03056EP, MDB03057EP, MDB03058EP, MDB03059EP, MDB03060EP, MDB03061EP, MDB03063EP, MDB03141EP, MDB03142EP, MDB03143EP, MDB03144EP, MDB03145EP, MDB03146EP, MDB03149EP, MDB03150EP, MDB03151EP, MDB03152EP, MDB03153EP, MDB03154EP, MDB03155EP,  MDB03156EP, MDB03157EP, MDB03158EP, MDB03159EP, MDB03161EP, MDB03163EP, MDB03164EP, MDB03165EP, MDB03167EP, MDB03168EP, MDB03169EP, MDB03171EP, MDB03172EP, MDB03173EP, MDB03174EP, MDB03175EP, MDB03176EP, MDB03177EP, MDB03178EP, MDB03179EP, MDB03180EP, MDB03181EP, MDB03182EP, MDB03183EP, MDB03184EP, MDB03185EP, MDB03186EP, MDB03187EP, MDB03188EP, MDB03189EP, MDB03190EP, MDB03191EP, MDB03192EP, MDB03193EP, MDB03194EP, MDB03195EP, MDB03196EP, MDB03197EP, MDB03198EP, MDB03199EP, MDB03200EP, MDB03201EP, MDB03202EP,MDB03203EP, MDB03204EP, MDB03206EP, MDB03207EP, MDB03208EP, MDB03209EP, MDB03210EP, MDB03211EP, MDB03214EP, MDB03215EP, MDB03216EP, MDB03217EP, MDB03219EP, MDB03220EP, MDB03221EP, MDB03222EP, MDB03223EP, MDB03224EP, MDB03225EP, MDB03226EP, MDB03227EP, MDB03228EP, MDB03230EP, MDB03231EP, MDB03232EP, MDB03233EP, MDB03235EP, MDB03236EP, MDB03237EP, MDB03238EP, MDB03418EP, MDB03419EP, MDB03420EP, MDB03422EP, MDB03424EP, MDB03425EP, MDB03426EP, MDB03428EP, MDB03429EP, MDB03430EP, MDB03431EP, MDB03432EP, MDB03433EP, MDB03434EP, MDB03435EP, MDB03437EP, MDB03438EP, MDB03439EP, MDB03441EP, MDB03442EP, MDB03443EP, MDB03444EP, MDB03445EP, MDB03446EP, MDB03447EP, MDB03448EP, MDB03449EP, MDB03450EP, MDB03453EP, MDB03454EP, MDB03507EP, MDB03508EP, MDB03509EP, MDB03510EP, MDB03511EP, MDB03512EP, MDB03513EP, MDB03514EP, MDB03515EP, MDB03516EP, MDB03517EP, MDB03518EP, MDB03520EP, MDB03521EP, MDB03522EP, MDB03523EP, MDB03524EP, MDB03525EP, MDB03527EP, MDB03528EP, MDB03529EP, MDB03530EP, MDB03531EP, MDB03532EP, MDB03533EP, MDB03534EP, MDB03535EP, MDB03536EP, MDB03537EP, MDB03538EP, MDB03539EP, MDB03540EP, MDB03541EP, MDB03542EP, MDB03543EP, MDB03544EP, MDB03545EP, MDB03546EP, MDB03548EP, MDB03549EP, MDB03550EP, MDB03551EP, MDB03552EP, MDB03553EP, MDB03554EP, MDB03555EP, MDB03556EP, MDB03558EP, MDB03559EP, MDB03560EP, MDB03561EP, MDB03562EP, MDB03563EP, MDB03564EP, MDB03565EP, MDB03566EP, MDB03567EP, MDB03568EP, MDB03569EP, MDB03570EP, MDB03571EP, MDB03572EP, MDB03573EP, MDB03574EP, MDB03575EP, MDB03576EP, MDB03577EP, MDB03578EP, MDB03579EP, MDB03580EP, MDB03581EP, MDB03582EP, MDB03583EP, MDB03585EP, MDB03586EP, MDB03587EP, MDB03588EP, MDB03589EP, MDB03590EP, MDB03592EP, MDB03594EP, MDB03595EP, MDB03596EP, MDB03597EP, MDB03598EP, MDB03599EP, MDB03600EP, MDB03601EP, MDB03602EP, MDB03603EP, MDB03604EP, MDB03605EP, MDB03606EP, MDB03677EP, MDB03678EP, MDB03679EP, MDB03680EP, MDB03682EP, MDB03683EP, MDB03684EP, MDB03685EP, MDB03686EP, MDB03687EP, MDB03688EP, MDB03689EP, MDB03690EP, MDB03691EP, MDB03765EP, MDB03767EP, MDB03768EP, MDB03769EP, MDB03770EP, MDB03771EP, MDB03772EP, MDB03773EP, MDB03774EP, MDB03775EP, MDB03777EP, MDB03778EP, MDB03779EP, MDB03780EP, MDB03781EP, MDB03782EP, MDB03784EP, MDB03785EP, MDB03786EP, MDB03787EP, MDB03788EP, MDB03789EP, MDB03790EP, MDB03791EP, MDB03792EP, MDB03793EP, MDB03794EP, MDB03796EP, MDB03797EP, MDB03798EP, MDB03799EP, MDB03801EP, MDB03802EP, MDB03803EP, MDB03804EP, MDB03805EP, MDB03806EP, MDB03807EP, MDB03808EP, MDB03809EP, MDB03811EP, MDB03812EP, MDB03814EP, MDB03816EP, MDB03818EP, MDB03820EP, MDB03821EP, MDB03822EP, MDB03832EP, MDB03833EP, MDB03834EP, MDB03835EP, MDB03836EP, MDB03837EP, MDB03839EP, MDB03840EP, MDB03841EP, MDB03842EP, MDB03843EP, MDB03844EP, MDB03845EP, MDB03846EP, MDB03847EP, MDB04041EP, MDB04042EP, MDB04043EP, MDB04044EP, MDB04045EP, MDB04046EP, MDB04047EP, MDB04048EP, MDB04049EP, MDB04050EP, MDB04051EP, MDB04052EP, MDB04053EP, MDB04054EP, MDB04055EP, MDB04057EP, MDB04059EP, MDB04061EP, MDB04062EP, MDB04063EP, MDB04064EP, MDB04065EP, MDB04066EP, MDB04067EP, MDB04068EP, MDB04069EP, MDB04070EP, MDB04071EP, MDB04073EP, MDB04074EP, MDB04075EP, MDB04076EP, MDB04077EP, MDB04078EP, MDB04079EP, MDB04080EP, MDB04081EP, MDB04082EP, MDB04083EP, MDB04084EP, MDB04085EP, MDB04087EP, MDB04088EP, MDB04090EP, MDB04093EP, MDB04095EP, MDB04096EP, MDB04097EP, MDB04098EP, MDB04099EP, MDB04100EP, MDB01020GP, MDB01021GP, MDB01022GP, MDB01023GP, MDB01024GP, MDB01137GP, MDB01138GP, MDB01139GP, MDB01140GP, MDB01141GP, MDB01142GP, MDB01143GP, MDB01144GP, MDB01145GP, MDB01146GP, MDB01147GP, MDB01148GP, MDB01149GP, MDB01150GP, MDB01151GP, MDB01152GP, MDB01153GP, MDB01154GP, MDB01155GP, MDB01156GP, MDB02549GP, MDB02550GP, MDB02551GP, MDB02553GP, MDB02555GP, MDB02556GP, MDB02558GP, MDB02559GP, MDB02560GP, MDB02561GP, MDB02562GP, MDB02563GP, MDB02565GP, MDB02566GP, MDB02567GP, MDB02568GP, MDB02569GP, MDB02570GP, MDB02571GP, MDB02572GP, MDB02573GP, MDB02574GP, MDB02947GP, MDB02949GP, MDB02950GP, MDB02951GP, MDB02952GP, MDB02955GP, MDB02956GP, MDB02957GP, MDB02960GP, MDB02961GP, MDB03295GP, MDB03296GP, MDB03297GP, MDB03298GP, MDB03299GP, MDB03300GP, MDB03301GP, MDB01030IP, MDB01031IP, MDB01032IP, MDB01033IP, MDB01034IP, MDB01157IP, MDB01158IP, MDB01159IP, MDB01160IP, MDB01161IP, MDB01162IP, MDB01163IP, MDB01164IP, MDB01165IP, MDB01166IP, MDB01167IP, MDB01168IP, MDB01169IP, MDB01170IP, MDB01171IP, MDB01172IP, MDB01173IP, MDB01174IP, MDB01175IP, MDB01176IP, MDB02575IP, MDB02576IP, MDB02577IP, MDB02578IP, MDB02580IP, MDB02581IP, MDB02582IP, MDB02583IP, MDB02584IP,MDB02585IP, MDB02586IP, MDB02587IP, MDB02588IP, MDB02589IP, MDB02590IP, MDB02591IP, MDB02592IP, MDB02593IP, MDB02594IP, MDB02595IP, MDB02596IP, MDB02597IP, MDB02598IP, MDB02962IP, MDB02963IP, MDB02964IP, MDB02965IP, MDB02966IP, MDB02967IP, MDB02968IP, MDB02969IP, MDB02970IP, MDB02971IP, MDB02972IP, MDB01827FP, MDB01828FP, MDB01829FP, MDB01830FP, MDB01831FP, MDB01852FP, MDB01853FP, MDB01854FP, MDB01855FP, MDB01856FP, MDB02250FP, MDB02251FP, MDB02252FP, MDB02253FP, MDB02254FP, MDB02255FP, MDB02256FP, MDB02257FP, MDB02363FP, MDB02364FP, MDB02365FP, MDB02366FP, MDB02367FP, MDB02368FP, MDB02369FP, MDB02782FP, MDB02784FP, MDB02785FP, MDB02786FP, MDB02787FP, MDB02788FP, MDB02789FP, MDB02790FP, MDB02791FP, MDB02974FP, MDB02975FP, MDB02976FP, MDB02977FP, MDB02978FP, MDB02979FP, MDB02980FP, MDB02981FP, MDB03359FP, MDB03361FP, MDB03362FP, MDB03364FP, MDB03365FP, MDB03366FP, MDB03367FP, MDB03368FP, MDB03370FP, MDB03371FP, MDB03372FP, MDB03373FP, MDB03375FP, MDB03383FP, MDB03384FP, MDB03385FP, MDB03386FP, MDB03388FP, MDB03389FP, MDB03390FP, MDB03391FP, MDB03392FP, MDB04003FP, MDB04004FP, MDB04006FP, MDB04007FP, MDB01822SP, MDB01823SP, MDB01824SP, MDB01825SP, MDB01826SP, MDB01864SP, MDB01865SP, MDB01866SP, MDB01867SP, MDB01868SP, MDB02160SP, MDB02161SP, MDB02162SP, MDB02163SP, MDB02164SP, MDB02245SP, MDB02246SP, MDB02247SP, MDB02248SP, MDB02249SP, MDB02353SP, MDB02354SP, MDB02355SP, MDB02356SP, MDB02357SP, MDB02358SP, MDB02359SP, MDB02360SP, MDB02361SP, MDB02362SP, MDB02770SP, MDB02771SP, MDB02772SP, MDB02773SP, MDB02774SP, MDB02775SP, MDB02776SP, MDB02777SP, MDB02778SP, MDB02779SP, MDB02780SP, MDB02781SP, MDB02982SP, MDB02983SP, MDB02984SP, MDB02985SP, MDB02986SP, MDB02987SP, MDB02988SP, MDB01277UP, MDB01279UP, MDB01282UP, MDB01284UP, 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  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Domestic distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Armenia, Austria, Bangladesh, Belgium, China, Dominican Republic, Finland, France, Germany, India, Ireland, Israel, Italy, Korea, Luxembourg, Malaysia, Nepal, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Sierra Leone, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Turkey, United Arab Emirates, United Kingdom.
  • Product Description
    Single Chamber Temporary External Pacemaker, Model 53401
  • Manufacturer
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
  • Manufacturer Address
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), 8200 Coral Sea St Ne, Mounds View MN 55112-4391
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA