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U.S. Department of Health and Human Services

Class 1 Device Recall HeartMate Touch Communication System

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  Class 1 Device Recall HeartMate Touch Communication System see related information
Date Initiated by Firm January 03, 2024
Date Posted February 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-0842-2024
Recall Event ID 93697
PMA Number P160054 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product 1. HeartMate Touch Communication System, REF HMT1100
2. HeartMate Touch Communication System, Rental REF HMT1100-R
3. HeartMate Touch Communication System, HMT1150

The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.
Code Information HeartMate Touch Communication System Model Number: HMT1100 UDI-DI Code: 05415067032058 Serial Numbers: DMPV40AAHP83 DMPVN1DFHP83 DMPVQ2JSHP51 DMPVQ374HP51 DMPVR6EXHP51 DMPVW1KDHP51 DMPW90USHP83 DMPWD118HP83 DMPWG096HP83 DMPWH036HP83 DMPWL02KHP83 DMPWL04QHP83 DMPWL05PHP83 DMPWL0AMHP83 DMPWL0T1HP83 DMPWL0XHHP83 DMPWL111HP83 DMPWL13CHP83 DMPWL14XHP83 DMPWL19RHP83 DMPWL1B7HP83 DMPWL1BPHP83 DMPWL1CCHP83 DMPWL1DVHP83 DMPWL21LHP83 DMPWL243HP83 DMPWL24PHP83 DMPWL29YHP83 DMPWL2BAHP83 DMPWL2DAHP83 DMPWM02VHP83 DMPWM0B5HP83 DMPWN01MHP83 DMPWN041HP83 DMPWN0A0HP83 DMPWN0AVHP83 DMPWN0XRJ28L DMPWR0AKHP83 DMPWR0AZHP83 DMPWR0BSHP83 DMPWR0C5HP83 DMPWR0CCHP83 DMPWR0DWHP83 DMPWR10BHP83 DMPWR11AHP83 DMPWR124HP83 DMPWR160HP83 DMPWR16ZHP83 DMPWR17CHP83 DMPWR17SHP83 DMPWR19BHP83 DMPWR19JHP83 DMPWR1D2HP83 DMPWR1DTHP83 DMPWR1F6HP83 DMPWR1MZHP83 DMPWT00PHP83 DMPWT02RHP83 DMPWT0CBHP83 DMPWT0NQHP83 DMPWT0PJHP83 DMPWT0URHP83 DMPWT0YHHP83 DMPWT118HP83 DMPWV09DHP83 DMPWV0BHHP51 DMPWV0C5HP83 DMPWV0C6HP83 DMPWV0CCHP83 DMPWV0CRHP83 DMPWV0DRHP83 DMPWV0DVHP83 DMPWV0E8HP83 DMPWV0EDHP83 DMPWV0FFHP83 DMPWV0FJHP83 DMPWV0FTHP83 DMPWV0GJHP83 DMPWV0GXHP83 DMPWV0H4HP83 DMPWV0H9HP83 DMPWV0J6HP83 DMPWV0JEHP83 DMPWV0JNHP83 DMPWV0K2HP83 DMPWV0K9HP83 DMPWV0LDHP83 DMPWW004HP83 DMPWW00KHP83 DMPWW00LHP83 DMPWW012HP83 DMPWW019HP83 DMPWW01BHP83 DMPWW04JHP83 DMPWW06PHP83 DMPWW095HP83 DMPWW0DKHP83 DMPWW0E9HP83 DMPWW0F1HP83 DMPWW0FGHP83 DMPWW0G7HP83 DMPWW0GAHP83 DMPWW0GBHP83 DMPWW0GLHP83 DMPWW0GWHP83 DMPWW0H0HP83 DMPWW0H1HP83 DMPWW0H7HP83 DMPWW0HLHP83 DMPWW0J7HP83 DMPWW0JGHP83 DMPWW0JZHP83 DMPWW0KDHP83 DMPWW0KKHP83 DMPWW0KWHP83 DMPWW0LCHP83 DMPWW0MCHP83 DMPWW0MKHP83 DMPWW0PWHP83 DMPWW0Q9J28L DMPWW0R5HP83 DMPWW0RGHP83 DMPWW0S5HP83 DMPX10UAHP51 DMPX10UDHP51 DMPX10ZMHP51 DMPX11Z2HP51 DMPX127EHP51 DMPX12GXHP51 DMPX12J0HP51 DMPX12JJHP51 DMPX12MKHP51 DMPX12RPHP51 DMPX12RRHP51 DMPX12S2HP51 DMPX12UPHP51 DMPX143YHP51 DMPX1AYLHP50 DMPX20FNHP83 DMPX20FPHP83 DMPX20G0HP83 DMPX20VNHP83 DMPX20VVHP83 DMPX20W2HP50 DMPX20ZRHP51 DMPX2141HP51 DMPX21A6HP83 DMPX21C8HP83 DMPX21LXHP83 DMPX21QAHP83 DMPX21TLHP51 DMPX228LHP50 DMPX22A2HP50 DMPX22B3HP50 DMPX22J4HP50 DMPX22WXHP51 DMPX2398HP51 DMPX3031HP83 DMPX304KHP83 DMPX305FHP83 DMPX30DEHP83 DMPX30E6HP83 DMPX30EDHP83 DMPX30EFHP83 DMPX30ELHP83 DMPX30FKHP83 DMPX30FPHP83 DMPX30FTHP83 DMPX30FWHP83 DMPX30G8HP83 DMPX30H8HP83 DMPX30H9HP83 DMPX30HBHP83 DMPX30HEHP83 DMPX30HGHP83 DMPX30J0HP83 DMPX30JHHP83 DMPX30JKHP83 DMPX30JNHP83 DMPX30JVHP83 DMPX30KCHP83 DMPX30KSHP83 DMPX30LXHP83 DMPX30M5HP83 DMPX30MHHP83 DMPX30MXHP83 DMPX30NCHP83 DMPX30NVHP83 DMPX30NXHP83 DMPX30P1HP83 DMPX30PFHP83 DMPX30PVHP83 DMPX30Q3HP83 DMPX30Q4HP83 DMPX30QQHP83 DMPX30RHHP83 DMPX30S3HP83 DMPX30SEHP83 DMPX30TMHP83 DMPX30TZHP83 DMPX30U7HP83 DMPX30USHP83 DMPX30UUHP83 DMPX30UYHP83 DMPX30VNHP83 DMPX30VRHP83 DMPX30WJHP83 DMPX30XXHP83 DMPX30YPHP83 DMPX30YSHP83 DMPX30Z3HP83 DMPX310WHP83 DMPX310YHP83 DMPX311MHP83 DMPX311SHP83 DMPX311VHP83 DMPX3126HP83 DMPX3127HP83 DMPX312GHP83 DMPX312QHP83 DMPX313CHP83 DMPX313MHP83 DMPX313NHP83 DMPX313UHP83 DMPX313YHP83 DMPX3148HP83 DMPX314LHP83 DMPX314NHP83 DMPX314SHP83 DMPX314WHP83 DMPX3152HP83 DMPX3158HP83 DMPX3159HP83 DMPX315BHP83 DMPX315KHP83 DMPX315QHP83 DMPX315XHP83 DMPX315YHP83 DMPX3169HP83 DMPX316HHP83 DMPX316MHP83 DMPX316XHP83 DMPX3172HP83 DMPX3177HP83 DMPX3179HP83 DMPX317MHP83 DMPX3180HP83 DMPX3186HP83 DMPX318CHP83 DMPX318FHP83 DMPX318QHP83 DMPX318UHP83 DMPX318YHP83 DMPX3195HP51 DMPX319BHP83 DMPX319CHP83 DMPX319VHP83 DMPX31AJHP83 DMPX31B4HP83 DMPX31CDHP83 DMPX31CWHP83 DMPX31D7HP51 DMPX31D8HP83 DMPX31DDHP83 DMPX31DVHP83 DMPX31EZHP83 DMPX31F7HP83 DMPX31F9HP83 DMPX31FDHP83 DMPX31FJHP83 DMPX31FKHP83 DMPX31GNHP83 DMPX31H4HP83 DMPX31X0HP51 DMPX31XZHP51 DMPX3238HP51 DMPX3459HP51 DMPX404VHP83 DMPX405UHP51 DMPX40AXHP83 DMPX41GLHP51 DMPX46T2HP50 DMPX470MHP50 DMPX50N3HP51 DMPX50P0HP50 DMPX50R3HP50 DMPX51E4HP51 DMPX51QLHP50 DMPX51RRHP50 DMPX51SVHP50 DMPX51V3HP50 DMPX51VKHP50 DMPX51ZAHP50 DMPX52NFHP51 DMPX52NPHP50 DMPX5310HP50 DMPX5357HP50 DMPX53J1HP50 DMPX53KZHP50 DMPX53WEHP50 DMPX53ZGHP50 DMPX544QHP50 DMPX54BQHP50 DMPX54DBHP50 DMPX54DWHP50 DMPX54EWHP50 DMPX54FQHP50 DMPX54FXHP50 DMPX54HGHP50 DMPX54KDHP50 DMPX54SRHP50 DMPX54VDHP50 DMPX54W9HP50 DMPX54WCHP50 DMPX5506HP50 DMPX5573HP50 DMPX557QHP50 DMPX5596HP50 DMPX559VHP50 DMPX559XHP50 DMPX55ASHP50 DMPX55D7HP50 DMPX55EGHP50 DMPX55FSHP50 DMPX55G7HP50 DMPX55L2HP50 DMPX55M2HP50 DMPX55MDHP50 DMPX55NWHP50 DMPX55P2HP50 DMPX55PTHP50 DMPX55Q2HP50 DMPX55QHHP50 DMPX55QZHP50 DMPX55VGHP50 DMPX55ZXHP50 DMPX563ZHP50 DMPX56FWHP50 DMPX56HLHP50 DMPX56J3HP50 DMPX56KRHP50 DMPX56LCHP50 DMPX56MEHP50 DMPX61WQJ28L DMPX61Y1J28L DMPX7115HP51 DMPX7174HP51 DMPX71DKHP51 DMPX71LAHP51 DMPX71LEHP51 DMPX71TXHP51 DMPX71V5HP51 DMPX71X0HP51 DMPX725HHP51 DMPX7282HP51 DMPX728LHP51 DMPX7299HP51 DMPX732UHP50 DMPX73GGHP50 DMPX74UNHP50 DMPX74VKHP50 DMPX74WCHP50 DMPX74WHHP50 DMPX74YCHP50 DMPX753LHP50 DMPX7595HP50 DMPX76DTHP50 DMPX76E6HP50 DMPX76ESHP50 DMPX76EWHP50 DMPX76FAHP50 DMPX76GGHP50 DMPX76GQHP50 DMPX76HLHP50 DMPX76HMHP50 DMPX76HWHP50 DMPX76JKHP50 DMPX76LKHP50 DMPX76NHHP50 DMPX76NZHP50 DMPX76QVHP50 DMPX76RCHP50 DMPX76RHHP50 DMPX76SYHP50 DMPX77DWHP50 DMPX77FSHP50 DMPX77LZHP50 DMPX77M2HP50 DMPX77NAHP50 DMPX77PUHP50 DMPX77SCHP50 DMPX77YNHP50 DMPX77Z9HP50 DMPX77ZWHP50 DMPX780AHP50 DMPX780EHP50 DMPX782GHP50 DMPX782WHP50 DMPX7839HP50 DMPX783BHP50 DMPX783VHP50 DMPX784NHP50 DMPX785JHP50 DMPX78A8HP50 DMPX78AEHP50 DMPX78CGHP50 DMPX78DUHP50 DMPX78G2HP50 DMPX78J5HP50 DMPX78J8HP50 DMPX78JQHP50 DMPX78NNHP50 DMPX78P5HP50 DMPX78P6HP50 DMPX78Q4HP50 DMPX78QHHP50 DMPX78QNHP50 DMPX78QQHP50 DMPX78RSHP50 DMPX78SHHP50 DMPX78STHP50 DMPX7935HP50 DMPX795PHP50 DMPX79K9HP50 DMPX7BFUHP50 DMPX80MYHP51 DMPX80Q4HP51 DMPX813ZHP51 DMPX822THP51 DMPX837VHP50 DMPX83FSHP50 DMPX903DHP83 DMPX9058HP83 DMPX905WHP83 DMPX965QHP50 DMPX96Z6HP50 DMPXC09PHP50 DMPXC0GZHP51 DMPXC0LEHP51 DMPXC18QHP51 DMPXC1Z0HP50 DMPXC359HP50 DMPXC4E7HP50 DMPXC4MXHP50 DMPXD0HEHP51 DMPXD13LHP51 DMPXD17GHP51 DMPXD1ASHP51 DMPXD1DVHP51 DMPXD1EDHP51 DMPXD1FAHP51 DMPXD1G9HP51 DMPXD1HKHP51 DMPXD1LMHP51 DMPXD1LWHP51 DMPXD1N9HP51 DMPXD1NLHP51 DMPXD1NMHP51 DMPXD1P1HP51 DMPXD1QRHP50 DMPXD1QSHP51 DMPXD1R2HP51 DMPXD1SHHP51 DMPXD1T9HP51 DMPXD21WJ28L DMPXD586HP50 DMPXF019HP83 DMPXF01RHP83 DMPXF04LHP83 DMPXF05SHP83 DMPXF07UHP83 DMPXF0ABHP83 DMPXF0B2HP83 DMPXF0J0HP83 DMPXF0QWHP83 DMPXF353HP51 DMPXG076HP83 DMPXG0L1HP83 DMPXG0Q7HP83 DMPXG0QJHP83 DMPXG0QPHP83 DMPXG0R7HP83 DMPXG0RKHP83 DMPXG0Z1HP51 DMPXG1PTHP51 DMPXG1QNHP51 DMPXG2DZHP51 DMPXH02HHP51 DMPXH09YHP51 DMPXH0AEHP51 DMPXJ009HP83 DMPXJ07PHP83 DMPXJ0BRHP83 DMPXJ0BXHP83 DMPXJ0C0HP83 DMPXJ0C2HP83 DMPXJ0CMHP83 DMPXJ0CSHP83 DMPXJ0CVHP83 DMPXJ0ERHP83 DMPXJ0FXHP83 DMPXJ0G5HP83 DMPXJ0G8HP83 DMPXJ0HNHP83 DMPXJ0HRHP83 DMPXJ0J8HP83 DMPXJ0MHHP83 DMPXJ0P8HP83 DMPXK001HP83 DMPXK00THP83 DMPXK00WHP83 DMPXK010HP83 DMPXK01RHP83 DMPXK01SHP83 DMPXK01ZHP83 DMPXK02UHP83 DMPXK03EHP83 DMPXK03GHP83 DMPXK03VHP83 DMPXK03WHP83 DMPXK03ZHP83 DMPXK040HP83 DMPXK048HP83 DMPXK049HP83 DMPXK04QHP83 DMPXK04RHP83 DMPXK04XHP83 DMPXK04ZHP83 DMPXK050HP83 DMPXK051HP83 DMPXK053HP83 DMPXK05FHP83 DMPXK05GHP83 DMPXK05SHP83 DMPXK05VHP83 DMPXK05WHP83 DMPXK05YHP83 DMPXK061HP83 DMPXK062HP83 DMPXK065HP83 DMPXK068HP83 DMPXK06JHP83 DMPXK06KHP83 DMPXK079HP83 DMPXK07DHP83 DMPXK083HP83 DMPXK08HHP83 DMPXK08KHP83 DMPXK08NHP83 DMPXK092HP83 DMPXK094HP83 DMPXK099HP83 DMPXK09DHP83 DMPXK09KHP83 DMPXK0A2HP83 DMPXK0ADHP83 DMPXK0AJHP83 DMPXK0AVHP83 DMPXK0B2HP83 DMPXK0B3J28L DMPXK0B8HP83 DMPXK0BEHP83 DMPXK0BRHP83 DMPXK0C4HP83 DMPXK0CBHP83 DMPXK0CEHP83 DMPXK0CFHP83 DMPXK0CJHP83 DMPXK0CSHP83 DMPXK0CUHP83 DMPXK0CZHP83 DMPXK0D0HP83 DMPXK0D6HP83 DMPXK0D9HP83 DMPXK0DBHP83 DMPXK0DJHP83 DMPXK0DSHP83 DMPXK0DVHP83 DMPXK0DXHP83 DMPXK0DYHP83 DMPXK0DZHP83 DMPXK0E0HP83 DMPXK0E2HP83 DMPXK0ECHP83 DMPXK0EDHP83 DMPXK0EEHP83 DMPXK0EFHP83 DMPXK0EMHP83 DMPXK0ENHP83 DMPXK0EPHP83 DMPXK0EWHP83 DMPXK0F7HP83 DMPXK0FGHP83 DMPXK0FKHP83 DMPXK0FTHP83 DMPXK0FWHP83 DMPXK0G6HP83 DMPXK0GHHP83 DMPXK0GTHP83 DMPXK0GWHP83 DMPXK0H5HP83 DMPXK0H6HP83 DMPXK0H7HP83 DMPXK0HCHP83 DMPXK0HDHP83 DMPXK0HEHP83 DMPXK0HQHP83 DMPXK0J3HP83 DMPXK0J4HP83 DMPXK0J7HP83 DMPXK0JAHP83 DMPXK0JCHP83 DMPXK0JGHP83 DMPXK0JMHP83 DMPXK0JPHP83 DMPXK0JQHP83 DMPXK0JRHP83 DMPXK0JVHP83 DMPXK0JZHP83 DMPXK0K0HP83 DMPXK0KSHP83 DMPXK0KTHP83 DMPXK0KUHP83 DMPXK0KYHP83 DMPXK0KZHP83 DMPXK0L1HP83 DMPXK0L8HP83 DMPXK0LBHP83 DMPXK0LHHP83 DMPXK0LKHP83 DMPXK0LPHP83 DMPXK0LTHP83 DMPXK0LUHP83 DMPXK0M5HP83 DMPXK0M7HP83 DMPXK0M9HP83 DMPXK0MCHP83 DMPXK0MHHP83 DMPXK0MPHP83 DMPXK0MRHP83 DMPXK0MSHP83 DMPXK0MXHP83 DMPXK0MZHP83 DMPXK0N7HP83 DMPXK0NKHP83 DMPXK0NPHP83 DMPXK0NVHP83 DMPXK0NYHP83 DMPXK0P1HP83 DMPXK0P2HP83 DMPXK0P3HP83 DMPXK0P7HP83 DMPXK0PAHP83 DMPXK0PDHP83 DMPXK0PLHP83 DMPXK0PRHP83 DMPXK0Q1HP83 DMPXK0Q3HP83 DMPXK0Q4HP83 DMPXK0Q6HP83 DMPXK0Q8HP83 DMPXK0Q9HP83 DMPXK0QAHP83 DMPXK0QCHP83 DMPXK0QEHP83 DMPXK0QHHP83 DMPXK0QJHP83 DMPXK0QLHP83 DMPXK0QPHP83 DMPXK0QRHP83 DMPXK0QTHP83 DMPXK0QWHP83 DMPXK0QXHP83 DMPXK0QZHP83 DMPXK0R3HP83 DMPXK0R7HP83 DMPXK0R8HP83 DMPXK0RAHP83 DMPXK0RBHP83 DMPXK0RCHP83 DMPXK0RDHP83 DMPXK0RGHP83 DMPXK0RJHP83 DMPXK0RMHP83 DMPXK0RNHP83 DMPXK0RRHP83 DMPXK0RSHP83 DMPXK0S0HP83 DMPXK0S2HP83 DMPXK0S4HP83 DMPXK0S5HP83 DMPXK0S6HP83 DMPXK0S8HP83 DMPXK0SAHP83 DMPXK0SMHP83 DMPXK0SRHP83 DMPXK0SVHP83 DMPXK0SZHP83 DMPXK0T0HP83 DMPXK0T1HP83 DMPXK0TAHP83 DMPXK0TBHP83 DMPXK0TCHP83 DMPXK0TFHP83 DMPXK0TRHP83 DMPXK0TVHP83 DMPXK0TXHP83 DMPXK0TZHP83 DMPXK0U0HP83 DMPXK0U2HP83 DMPXK0UMHP83 DMPXK0UNHP83 DMPXK0V6HP83 DMPXK0VCHP83 DMPXK0VDHP83 DMPXK0VFHP83 DMPXK0VJHP83 DMPXK0VKHP83 DMPXK0VPHP83 DMPXK0VQHP83 DMPXK0VRHP83 DMPXK0VVHP83 DMPXK0VYHP83 DMPXK0W2HP83 DMPXK0W6HP83 DMPXK0W7HP83 DMPXK0WDHP83 DMPXK0WGHP83 DMPXK0WJHP83 DMPXK0WLHP83 DMPXK0WNHP83 DMPXK0X5HP83 DMPXK0X6HP83 DMPXK0XAHP83 DMPXK0XCHP83 DMPXK0XHHP83 DMPXK0XNHP83 DMPXK0XTHP83 DMPXK0Y0HP83 DMPXK0Y1HP83 DMPXK0Y4HP83 DMPXK0Y5HP83 DMPXK0Y6HP83 DMPXK0YJHP83 DMPXK0Z2HP83 DMPXK0Z8HP83 DMPXK0ZCHP83 DMPXK0ZFHP83 DMPXK0ZJHP83 DMPXK0ZQHP83 DMPXK104HP83 DMPXK105HP83 DMPXK107HP83 DMPXK108HP83 DMPXK109HP83 DMPXK10BHP83 DMPXK10DHP83 DMPXK10KHP83 DMPXK10LHP83 DMPXK10MHP83 DMPXK10PHP83 DMPXK10QHP83 DMPXK10UHP83 DMPXK10ZHP83 DMPXK110HP83 DMPXK112HP83 DMPXK114HP83 DMPXK118HP83 DMPXK119HP83 DMPXK11DHP83 DMPXK11LHP83 DMPXK11NHP83 DMPXK11UHP83 DMPXK11YHP83 DMPXK120HP83 DMPXK121HP83 DMPXK125HP83 DMPXK12BHP83 DMPXK12HHP83 DMPXK12JHP83 DMPXK12MHP83 DMPXK12PHP83 DMPXK12QHP83 DMPXK130HP83 DMPXK133HP83 DMPXK134HP83 DMPXK135HP83 DMPXK136HP83 DMPXK139HP83 DMPXK13LHP83 DMPXK13XHP83 DMPXK140HP83 DMPXK145HP83 DMPXK14AHP83 DMPXK14CHP83 DMPXK14FHP83 DMPXK14GHP83 DMPXK14KHP83 DMPXK14RHP83 DMPXK14UHP83 DMPXK14YHP83 DMPXK154HP83 DMPXK158HP83 DMPXK159HP83 DMPXK15LHP83 DMPXK15UHP83 DMPXK16DHP83 DMPXK16EHP83 DMPXK16LHP83 DMPXK16YHP83 DMPXK170HP83 DMPXK172HP83 DMPXK173HP83 DMPXK17BHP83 DMPXK17CHP83 DMPXK17DHP83 DMPXK17FHP83 DMPXK17NHP83 DMPXK17RHP83 DMPXK17SHP83 DMPXK17THP83 DMPXK17UHP83 DMPXK17VHP83 DMPXK18CHP83 DMPXK18GHP83 DMPXK18QHP83 DMPXK18UHP83 DMPXK191HP83 DMPXK19EHP83 DMPXK19GHP83 DMPXK19NHP83 DMPXK19WHP83 DMPXK19YHP83 DMPXK1ACHP83 DMPXK1AHHP83 DMPXK1AMHP83 DMPXK1AWHP83 DMPXK1B1HP83 DMPXK1B2HP83 DMPXK1B3HP83 DMPXK1B6HP83 DMPXK1BAHP83 DMPXK1BFHP83 DMPXK1BRHP83 DMPXK1BVHP83 DMPXK1CYHP83 DMPXK1D4HP83 DMPXK1D8HP83 DMPXK1DDHP83 DMPXK1DFHP83 DMPXK1DVHP83 DMPXK1DWHP83 DMPXK1DXHP83 DMPXK1E8HP83 DMPXK1EGHP83 DMPXK1F1HP83 DMPXK1F3HP83 DMPXK1F9HP83 DMPXK1FGHP83 DMPXK1FKHP83 DMPXK1FRHP83 DMPXK1JXHP83 DMPXK1K8HP83 DMPXK1K9HP83 DMPXK1KBHP83 DMPXK1KLHP83 DMPXK1KNHP83 DMPXK1L5HP83 DMPXK1MDHP83 DMPXK1MMHP83 DMPXK1N8HP83 DMPXK1NSHP83 DMPXK1NZHP83 DMPXK1P0HP83 DMPXK1P1HP83 DMPXK1P6HP83 DMPXK1PAHP83 DMPXK1PDHP83 DMPXK1PHHP83 DMPXK1PKHP83 DMPXK1PQHP83 DMPXK1PSHP83 DMPXK1PWHP83 DMPXK1PXHP83 DMPXK1PYHP83 DMPXK1Q2HP83 DMPXK1Q8HP83 DMPXK1QLHP83 DMPXK1QPHP83 DMPXK1QWHP83 DMPXK1QXHP83 DMPXK1R1HP83 DMPXK1RCHP83 DMPXK1RHHP83 DMPXK1RQHP83 DMPXK1RUHP83 DMPXK1RWHP83 DMPXK1SQHP83 DMPXK1SVHP83 DMPXK1T6HP83 DMPXK1TBHP83 DMPXK1TQHP83 DMPXK1TXHP83 DMPXK1U5HP83 DMPXK1UJHP83 DMPXK1V2HP83 DMPXK1V7HP83 DMPXK1V8HP83 DMPXK1VYHP83 DMPXK1W3HP83 DMPXK1W4HP83 DMPXK1W7HP83 DMPXK1WBHP83 DMPXK1WHHP83 DMPXK1WMHP83 DMPXK1WQHP83 DMPXK1WUHP83 DMPXK1WVHP83 DMPXK1XLHP83 DMPXK1Y3HP83 DMPXK1Y8HP83 DMPXK1YFHP83 DMPXK1YHHP83 DMPXK1YWHP83 DMPXK249HP83 DMPXK27UHP83 DMPXK297HP83 DMPXK2ADHP83 DMPXL002HP83 DMPXL006HP83 DMPXL00KHP83 DMPXL00PHP83 DMPXL00RHP83 DMPXL00SHP83 DMPXL00VHP83 DMPXL00WHP83 DMPXL00ZHP83 DMPXL019HP83 DMPXL01VHP83 DMPXL01YHP83 DMPXL02RHP83 DMPXL02YHP83 DMPXL032HP83 DMPXL03EHP83 DMPXL03KHP83 DMPXL04DHP83 DMPXL04KHP83 DMPXL04ZHP83 DMPXL050HP83 DMPXL05CHP83 DMPXL05GHP83 DMPXL05XHP83 DMPXL063HP83 DMPXL064HP83 DMPXL066HP83 DMPXL06YHP83 DMPXL073HP83 DMPXL075HP83 DMPXL07AHP83 DMPXL07XHP83 DMPXL081HP83 DMPXL086HP83 DMPXL087HP83 DMPXL08AHP83 DMPXL08EHP83 DMPXL08FHP83 DMPXL08MHP83 DMPXL08THP83 DMPXL08YHP83 DMPXL08ZHP83 DMPXL092HP83 DMPXL09CHP83 DMPXL09KHP83 DMPXL09YHP83 DMPXL0A1HP83 DMPXL0A5HP83 DMPXL0A6HP83 DMPXL0ABHP83 DMPXL0AEHP83 DMPXL0AHHP83 DMPXL0AMHP83 DMPXL0AQHP83 DMPXL0ASHP83 DMPXL0AVHP83 DMPXL0AXHP83 DMPXL0B0HP83 DMPXL0B6HP83 DMPXL0B9HP83 DMPXL0BZHP83 DMPXL0CDHP83 DMPXL0CGHP83 DMPXL0CSHP83 DMPXL0CZHP83 DMPXL0D3HP83 DMPXL0D9HP83 DMPXL0DCHP83 DMPXL0DGHP83 DMPXL0DRHP83 DMPXL0DXHP83 DMPXL0EDHP83 DMPXM04GHP51 DMPXM04RHP51 DMPXM0JCJ28L DMPXM0MPHP51 DMPXM1KSHP50 DMPXN011HP51 DMPXN01RHP51 DMPXN02MHP51 DMPXN02QHP51 DMPXN03MHP51 DMPXN03ZHP51 DMPXN04YHP51 DMPXN054HP51 DMPXN059HP51 DMPXN05AHP51 DMPXN06FHP51 DMPXN06JHP51 DMPXN070HP83 DMPXN07PHP51 DMPXN07THP51 DMPXN08MHP83 DMPXN09DHP51 DMPXN09THP51 DMPXN0C7HP51 DMPXN0F3HP51 DMPXN0MCHP51 DMPXN11RHP50 DMPXN131HP50 DMPXN16ZHP50 DMPXN19EHP50 DMPXN1QWHP50 DMPXN1RDHP50 DMPXN23LHP50 DMPXN25EHP50 DMPXN294HP50 DMPXN29RHP50 DMPXN2AXHP50 DMPXN2CUHP50 DMPXN2DHHP50 DMPXN2DMHP50 DMPXN2DXHP50 DMPXN2ECHP50 DMPXN2EFHP50 DMPXN2TUHP50 DMPXN2U8HP50 DMPXN2UUHP50 DMPXN2YGHP50 DMPXN332HP50 DMPXN33UHP50 DMPXN34RHP50 DMPXN350HP50 DMPXN35EHP50 DMPXN388HP50 DMPXN3A8HP50 DMPXN3C9HP50 DMPXN3CYHP50 DMPXN3FAHP50 DMPXN3FSHP50 DMPXN3JCHP50 DMPXN3LJHP50 DMPXN3LNHP50 DMPXN3LSHP50 DMPXN3NJHP50 DMPXN3STHP50 DMPXN407HP50 DMPXN4AZHP50 DMPXN4DCHP50 DMPXP0AFHP83 DMPXP0BGHP83 DMPXP0CCHP83 DMPXP0CQHP83 DMPXP0D2HP83 DMPXP0DGHP83 DMPXP0DPHP83 DMPXP0DQHP83 DMPXP0DVHP83 DMPXP0E1HP83 DMPXP0ERHP83 DMPXP0F7HP83 DMPXP0FLHP83 DMPXP0FMHP83 DMPXP0FNHP83 DMPXP0G5HP83 DMPXP0P9HP51 DMPXP0Q3HP51 DMPXP0QHHP51 DMPXP0Z6HP51 DMPXP237HP50 DMPXQ003HP83 DMPXQ004HP83 DMPXQ005HP83 DMPXQ00BHP83 DMPXQ00CHP83 DMPXQ00FHP83 DMPXQ00HHP83 DMPXQ00JHP83 DMPXQ00KHP83 DMPXQ00PHP83 DMPXQ00THP83 DMPXQ00UHP83 DMPXQ010HP83 DMPXQ015HP83 DMPXQ016HP83 DMPXQ017HP83 DMPXQ01CHP83 DMPXQ01FHP83 DMPXQ01GHP83 DMPXQ01LHP83 DMPXQ01MHP83 DMPXQ01PHP83 DMPXQ01THP83 DMPXQ01WHP83 DMPXQ01YHP83 DMPXQ020HP83 DMPXQ021HP83 DMPXQ025HP83 DMPXQ026HP83 DMPXQ028HP83 DMPXQ029HP83 DMPXQ02CHP83 DMPXQ02HHP83 DMPXQ02THP83 DMPXQ02XHP83 DMPXQ034HP83 DMPXQ038HP83 DMPXQ03CHP83 DMPXQ03DHP83 DMPXQ03FHP83 DMPXQ03MHP83 DMPXQ03NHP83 DMPXQ03VHP83 DMPXQ043HP83 DMPXQ048HP83 DMPXQ04CHP83 DMPXQ04LHP83 DMPXQ04ZHP83 DMPXQ055HP83 DMPXQ057HP83 DMPXQ05FHP83 DMPXQ05GHP83 DMPXQ05UHP83 DMPXQ05VHP83 DMPXQ061HP83 DMPXQ06FHP83 DMPXQ06PHP83 DMPXQ06WHP83 DMPXQ06ZHP83 DMPXQ076HP83 DMPXQ078HP83 DMPXQ07DHP83 DMPXQ07EHP83 DMPXQ07VHP83 DMPXQ07YHP83 DMPXQ083HP83 DMPXQ085HP83 DMPXQ08EHP83 DMPXQ08SHP83 DMPXQ09AHP83 DMPXQ09JHP83 DMPXQ09KHP83 DMPXQ09RHP83 DMPXQ09VHP83 DMPXQ0A0HP83 DMPXQ0A6HP83 DMPXQ0ADHP83 DMPXQ0AQHP83 DMPXQ0BHHP83 DMPXQ0BRHP83 DMPXQ0BWHP83 DMPXQ0BZHP83 DMPXQ0C1HP83 DMPXQ0C3HP83 DMPXQ0C9HP83 DMPXQ0CDHP83 DMPXQ0CGHP83 DMPXQ0CHHP83 DMPXQ0CPHP83 DMPXQ0CQHP83 DMPXQ0CRHP83 DMPXQ0CYHP83 DMPXQ0D0HP83 DMPXQ0D1HP83 DMPXQ0D2HP83 DMPXQ0D4HP83 DMPXQ0D7HP83 DMPXQ0DDHP83 DMPXQ0DEHP83 DMPXQ0DKHP83 DMPXQ0DQHP83 DMPXQ0DXHP83 DMPXQ0DZHP83 DMPXQ0E1HP83 DMPXQ0E3HP83 DMPXQ0E9HP83 DMPXQ0EAHP83 DMPXQ0EBHP83 DMPXQ0EGHP83 DMPXQ0EKHP83 DMPXQ0ELHP83 DMPXQ0ENHP83 DMPXQ0EQHP83 DMPXQ0ERHP83 DMPXQ0ETHP83 DMPXQ0EZHP83 DMPXQ0F1HP83 DMPXQ0F4HP83 DMPXQ0F5HP83 DMPXQ0FBHP83 DMPXQ0FDHP83 DMPXQ0FEHP83 DMPXQ0FKHP83 DMPXQ0FYHP83 DMPXQ0FZHP83 DMPXQ0G5HP83 DMPXQ0G8HP83 DMPXQ0G9HP83 DMPXQ0GGHP83 DMPXQ0GJHP83 DMPXQ0GKHP83 DMPXQ0GLHP83 DMPXQ0GQHP83 DMPXQ0GZHP83 DMPXQ0H2HP83 DMPXQ0H4HP83 DMPXQ0HJHP83 DMPXQ0HRHP83 DMPXQ0HSHP83 DMPXQ0HTHP83 DMPXQ0HUHP83 DMPXQ0HWHP83 DMPXQ0J6HP83 DMPXQ0J8HP83 DMPXQ0JEHP83 DMPXQ0JHHP83 DMPXQ0JPHP83 DMPXQ0JZHP83 DMPXQ0K0HP83 DMPXQ0K5HP83 DMPXQ0K6HP83 DMPXQ0K7HP83 DMPXQ0KAHP83 DMPXQ0KCHP83 DMPXQ0KFHP83 DMPXQ0KGHP83 DMPXQ0KHHP83 DMPXQ0KNHP83 DMPXQ0KPHP83 DMPXQ0KRHP83 DMPXQ0KSHP83 DMPXQ0L2HP83 DMPXQ0L3HP83 DMPXQ0L4HP83 DMPXQ0L6HP83 DMPXQ0LAHP83 DMPXQ0LDHP83 DMPXQ0LJHP83 DMPXQ0LKHP83 DMPXT0STHP50 DMPXT174HP50 DMPXV36MHP50 DMPXV3CPHP50 DMPXV4M3HP50 DMPXV4QFHP50 DMPXV4VVHP50 DMPXV4XXHP50 DMPXV4YPHP50 DMPXV50AHP50 DMPXV51FHP50 DMPXV51UHP50 DMPXV53NHP50 DMPXV545HP50 DMPXV56MHP50 DMPXV5C5HP50 DMPXV5THHP50 DMPXW090HP50 DMPXW09AHP50 DMPXW0AMHP50 DMPXW0AYHP50 DMPXW0B0HP50 DMPXW0B3HP50 DMPXW0BDHP50 DMPXW0BPHP50 DMPXW0BTHP50 DMPXW0BWHP50 DMPXW0CTHP50 DMPXW0CYHP50 DMPXW0D7HP50 DMPXW0DEHP50 DMPXW0DHHP50 DMPXW0DLHP50 DMPXW0E2HP50 DMPXW0EEHP50 DMPXW0FUHP50 DMPXW0GUHP50 DMPXW0J5HP50 DMPXW0LJHP50 DMPXW0WMJ28L DMPXW1QMHP50 DMPXX05VHP50 DMPXX0F5HP50 DMPXX0PYHP50 DMPXX0Y3HP50 DMPXX12PHP50 DMPXX137HP50 DMPXX13GHP50 DMPXX13HHP50 DMPXX18CHP50 DMPXX1BWHP50 DMPXX1CMHP50 DMPXX1DNHP50 DMPXX1ERHP50 DMPXX1F1HP50 DMPXX1GAHP50 DMPXX26HHP50 DMPY1014HP83 DMPY101EHP83 DMPY1089HP50 DMPY108CHP51 DMPY10F5HP50 DMPY10FQHP50 DMPY10PJHP50 DMPY10RLHP50 DMPY30E0HP50 DMPY30EXHP50 DMPY30Z9J28L DMPY30ZKJ28L DMPY4008HP50 DMPY400QHP50 DMPY4013HP50 DMPY4018HP50 DMPY402KHP50 DMPY403DHP50 DMPY404DHP50 DMPY4057HP50 DMPY4061HP50 DMPY4066HP50 DMPY407ZHP50 DMPY4088HP50 DMPY408LHP50 DMPY409SHP50 DMPY409YHP50 DMPY40ACHP50 DMPY40ASHP50 DMPY40AXHP50 DMPY40BEHP50 DMPY40BSHP50 DMPY40DTHP50 DMPY40DXHP50 DMPY40HLHP50 DMPY40HNHP50 DMPY40J1HP50 DMPY40MNHP50 DMPY40MRHP50 DMPY40MWHP50 DMPY7001HP50 DMPY7008HP50 DMPY700UHP50 DMPY701GHP50 DMPY702KHP50 DMPY70C2HP50 DMPY70C3HP50 DMPY70CAHP50 DMPY70CEHP50 DMPY70CRHP50 DMPY70CYHP50 DMPY8002HP83 DMPY8007HP83 DMPY800FHP50 DMPY800KHP50 DMPY800SHP83 DMPY800THP50 DMPY800THP83 DMPY800YHP50 DMPY800ZHP50 DMPY8010HP50 DMPY8019HP50 DMPY801DHP50 DMPY801FHP83 DMPY80Q0J28L DMPY902LHP50 DMPY907EJ28L DMPY90ABHP50 DMPY90BWHP50 DMPY90CVHP50 DMPY90DUJ28L DMPY90EPJ28L DMPY90H6HP50 DMPY90KQHP50 DMPY90KXJ28L DMPY90L6J28L DMPY90NCJ28L DMPY90NKJ28L DMPY90NNJ28L DMPY90QFJ28L DMPYC002HP50 DMPYC006HP50 DMPYC007HP83 DMPYC008HP50 DMPYC00AHP50 DMPYC00CHP50 DMPYC00CHP83 DMPYC00FHP50 DMPYC00JHP50 DMPYC00PHP50 DMPYC00RHP83 DMPYC00SHP83 DMPYC00UHP50 DMPYC00VHP83 DMPYC00ZHP50 DMPYC010HP50 DMPYC013HP83 DMPYC014HP83 DMPYC015HP83 DMPYC016HP51 DMPYC019HP83 DMPYC01FHP83 DMPYC01HHP50 DMPYC01HHP83 DMPYC01JHP83 DMPYC01KHP83 DMPYC01LHP51 DMPYC01LHP83 DMPYC01UHP51 DMPYC01ZHP50 DMPYC020HP50 DMPYC022HP50 DMPYC023HP50 DMPYC026HP50 DMPYC02NHP50 DMPYC02QHP51 DMPYC02XHP50 DMPYC02YHP50 DMPYC038HP50 DMPYC03CHP50 DMPYC03PHP50 DMPYC03QHP50 DMPYC03RHP50 DMPYC03UHP50 DMPYC03WHP50 DMPYC041HP50 DMPYC045HP50 DMPYC04CHP50 DMPYC056HP51 DMPYD004HP50 DMPYD006HP50 DMPYD00AHP83 DMPYD00BHP50 DMPYD00BHP83 DMPYD00CHP50 DMPYD00DHP50 DMPYD00FHP50 DMPYD00HHP50 DMPYD00JHP50 DMPYD00KHP50 DMPYD00LHP50 DMPYD00RHP50 DMPYD00RHP83 DMPYD00UHP50 DMPYD00ZHP50 DMPYD012HP50 DMPYD016HP50 DMPYD016HP83 DMPYD018HP83 DMPYD019HP83 DMPYD01AHP50 DMPYD01DHP50 DMPYD01GHP50 F6QZ800UHP83 HeartMate Touch Communication System, Rental Model Number: HMT1100-R UDI-DI Code: 05415067033758 Serial Numbers: DMPWL0Y3HP83 DMPXQ006HP83 DMPXQ031HP83 DMPXQ0C7HP83 DMPXQ0JMHP83 HeartMate Touch Communication System Model Number: HMT1150 UDI-DI Code: 05415067032041 Serial Numbers: DMPVJAYAHP51 DMPWL1A2HP83 DMPWR6PNHP50 DMPWV0DGHP51 DMPX12NSHP51 DMPX13DAHP51 DMPX22F4HP50 DMPX31NWHP51 DMPX50PBHP50 DMPX54VFHP50 DMPX55LLHP50 DMPX55MVHP50 DMPX7148HP51 DMPX71E7HP51 DMPX71RNHP51 DMPX75RFHP50 DMPX76JYHP50 DMPX77NMHP50 DMPX77RSHP50 DMPX77V5HP50 DMPX781ZHP50 DMPX789JHP50 DMPX78N2HP50 DMPX78Q5HP50 DMPX78W2HP50 DMPXC02HHP50 DMPXC04MHP50 DMPXC05PHP84 DMPXC0E1HP50 DMPXC0NKHP51 DMPXD1GAHP51 DMPXD1PRHP51 DMPXG1M1HP51 DMPXJ0L8HP83 DMPXK01LHP83 DMPXK05RHP83 DMPXK0BMHP83 DMPXK0NSHP83 DMPXK1QAHP83 DMPXK27PHP83 DMPXL0EKHP83 DMPXN01WHP51 DMPXN03PHP51 DMPXN06KHP51 DMPXN08NHP51 DMPXN0J7HP51 DMPXN1AJHP50 DMPXN1C3HP50 DMPXN1SJHP50 DMPXN2A7HP50 DMPXN2DUHP50 DMPXN2XFHP50 DMPXN3B3HP50 DMPXN3HWHP50 DMPXN3LGHP50 DMPXP0E2HP83 DMPXP0F4HP83 DMPXP0FZHP83 DMPXP0PBHP51 DMPXP0QAHP51 DMPXQ021HP51 DMPXQ041HP83 DMPXQ068HP83 DMPXQ097HP83 DMPXQ09PHP83 DMPXQ0AYHP83 DMPXQ0KEHP83 DMPXR0B4J28L DMPXV4ZXHP50 DMPXW0B6HP50 DMPXW0KUHP50 DMPXW0RQJ28L DMPXW0YAJ28L DMPXX07SHP50 DMPXX0VBHP51 DMPXX11QHP50 DMPXX1FJHP50 DMPY10P5HP50 DMPY30ZJJ28L DMPY40ELJ28L DMPY800XHP50 DMPY90JKJ28L DMPY90KBJ28L DMPY90N7J28L DMPYC03HHP51 DMPYC03KHP50 DMPYC05RHP51
Recalling Firm/
Manufacturer		 Thoratec Corp.
6035 Stoneridge Dr
Pleasanton CA 94588-3270
For Additional Information Contact Ms Beth Crain
651-756-5129
Manufacturer Reason
for Recall		 Due to software and controller systems that results in unexpected pump start or pump stop.
FDA Determined
Cause 2		 Software design
Action On 01/03/2024, the firm sent an Urgent Medical Device Correction Letter via hand delivery to U.S. customers informing them that Abbott has received complaints for the HeartMate Touch Communication System application (App) version 1.0.32 due to unintentional start/stop of the HeartMate 3 Left Ventricle Assist Device (LVAD). -Customer should be able to identify the software version of the HeartMate Touch App by tapping "Menu" and "About" on the left-hand panel on the HeartMate Touch screen. -When the "STOP PUMP" sequence needs to be performed, follow the instructions in the Instructions For Use (IFU), Chapter 4 HeartMate Touch Communication System Pages 4-58 to 4-59. -The user can prevent the unintentional LVAD start/stop from occurring by following the IFU and these additional guidance and recommendations. Note that communication may also be interrupted if the Wireless Adaptor is disconnected from the HeartMate Touch system prior to completion of the STOP PUMP sequence. -Do not disconnect the HeartMate System Controller white cable or the Wireless Adapter from the Power Module until STOP PUMP sequence screen with the red progress bar is no longer visible and the STOP PUMP screen changes automatically. -During pump priming, do not disconnect the pump until the timer reaches zero, the pump stops, and the Priming is complete message appears as instructed per the IFU. Abbott is developing and will release a software update to prevent the sequence of events described above. This product correction will be included in an upcoming release of the HeartMate Touch software. An Abbott Representative will contact you for a software upgrade beginning Q2 2024. For questions, contact Abbott Technical Support at 1-800-456-1477.
Quantity in Commerce 1,560 systems as of 12/8/2023
Distribution Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand and United Arab Emirates.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Abbott Medical
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