Class 2 Device Recall Medtronic Model 53401 Single Chamber External Pulse Generator

• Date Initiated by Firm: June 06, 2018
• Date Posted: June 29, 2018
• Recall Status: Terminated on August 13, 2021
• Recall Number: Z-2317-2018
• Recall Event ID: 80267
• 510(K)Number: K162054
• Product Classification: Pulse-generator, pacemaker, external - Product Code DTE
• Product: Single Chamber Temporary External Pacemaker, Model 53401
• Code Information: 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, 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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, 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• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: 800-638-1991
• Manufacturer Reason for Recall: 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).
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 1,108 devices
• 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.
• 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.

• 510(K) Database: 510(K)s with Product Code = DTE and Original Applicant = MEDTRONIC, INC.