Z-1692-2024 Class I Ongoing

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

UDI: 00813024013297/Serial Number: MLP-026628 MLP-026733 MLP-026929 MLP-027005 MLP-027322 MLP-027363 MLP-027387 MLP-027390 MLP-027596 MLP-027678 MLP-027879 MLP-028290 MLP-028518 MLP-028665 MLP-028754 MLP-028931 MLP-029026 MLP-029108 MLP-029187 MLP-029304 MLP-029368 MLP-029462 MLP-029473 MLP-029656 MLP-029682 MLP-029686 MLP-029845 MLP-030174 MLP-030180 MLP-030215 MLP-030216 MLP-030844 MLP-030945 MLP-030993 MLP-031350 MLP-031430 MLP-031507 MLP-031529 MLP-031710 MLP-031725 MLP-031780 MLP-032045 MLP-032092 MLP-032194 MLP-032302 MLP-032534 MLP-032794 MLP-032917 MLP-032926 MLP-032952 MLP-033026 MLP-033232 MLP-033394 MLP-033541 MLP-033633 MLP-033799 MLP-033829 MLP-033875 MLP-033905 MLP-033948 MLP-033960 MLP-033981 MLP-034050 MLP-034055 MLP-034059 MLP-034089 MLP-034090 MLP-034098 MLP-034135 MLP-034144 MLP-034184 MLP-034266 MLP-034380 MLP-034582 MLP-034594 MLP-034719 MLP-034721 MLP-034724 MLP-034816 MLP-034821 MLP-034835 MLP-034877 MLP-034879 MLP-034883 MLP-034926 MLP-035031 MLP-035032 MLP-035098 MLP-035148 MLP-035177 MLP-035386 MLP-035387 MLP-035510 MLP-035528 MLP-035588 MLP-035609 MLP-035613 MLP-035691 MLP-035700 MLP-035925 MLP-035931 MLP-036123 MLP-036166 MLP-036173 MLP-036254 MLP-036298 MLP-036367 MLP-036413 MLP-036644 MLP-036749 MLP-036797 MLP-036815 MLP-036831 MLP-036872 MLP-037066 MLP-037152 MLP-037213 MLP-037396 MLP-037436 MLP-037470 MLP-037517 MLP-037702 MLP-037746 MLP-037758 MLP-037792 MLP-037867 MLP-037928 MLP-037939 MLP-037945 MLP-038129 MLP-038147 MLP-038156 MLP-038281 MLP-038325 MLP-038467 MLP-038696 MLP-038743 MLP-038783 MLP-038791 MLP-038796 MLP-038858 MLP-038941 MLP-038942 MLP-039006 MLP-039012 MLP-039039 MLP-039051 MLP-039071 MLP-039257 MLP-039346 MLP-039406 MLP-039423 MLP-039450 MLP-039464 MLP-039465 MLP-039471 MLP-039483 MLP-039492 MLP-039496 MLP-039515 MLP-039522 MLP-039534 MLP-039590 MLP-039629 MLP-039635 MLP-039636 MLP-039638 MLP-039651 MLP-039679 MLP-039680 MLP-039681 MLP-039687 MLP-039718 MLP-039721 MLP-039723 MLP-039764 MLP-039770 MLP-039799 MLP-039813 MLP-039815 MLP-039874 MLP-039880 MLP-039892 MLP-039893 MLP-039896 MLP-039902 MLP-039968 MLP-039984 MLP-039985 MLP-039997 MLP-040020 MLP-040022 MLP-040030 MLP-040068 MLP-040080 MLP-040176 MLP-040178 MLP-040182 MLP-040195 MLP-040207 MLP-040212 MLP-040243 MLP-040300 MLP-040301 MLP-040309 MLP-040331 MLP-040334 MLP-040343 MLP-040393 MLP-040397 MLP-040415 MLP-040437 MLP-040438 MLP-040451 MLP-040453 MLP-040455 MLP-040472 MLP-040477 MLP-040486 MLP-040491 MLP-040492 MLP-040493 MLP-040498 MLP-040501 MLP-040502 MLP-040520 MLP-040544 MLP-040550 MLP-040557 MLP-040658 MLP-040678 MLP-040719 MLP-040735 MLP-040736 MLP-040740 MLP-040743 MLP-040799 MLP-040800 MLP-040805 MLP-040841 MLP-040842 MLP-040862 MLP-040870 MLP-040871 MLP-040875 MLP-040879 MLP-040900 MLP-040917 MLP-040925 MLP-040931 MLP-040938 MLP-040942 MLP-040944 MLP-040946 MLP-040947 MLP-040951 MLP-040955 MLP-040956 MLP-040977 MLP-040982 MLP-040986 MLP-040991 MLP-041016 MLP-041221 MLP-041234 MLP-041237 MLP-041241 MLP-041257 MLP-041258 MLP-041259 MLP-041260 MLP-041263 MLP-041264 MLP-041265 MLP-041266 MLP-041267 MLP-041268 MLP-041269 MLP-041271 MLP-041272 MLP-041273 MLP-041276 MLP-041277 MLP-041285 MLP-041286 MLP-041287 MLP-041288 MLP-041289 MLP-041290 MLP-041291 MLP-041292 MLP-041293 MLP-041294 MLP-041295 MLP-041296 MLP-041297 MLP-041299 MLP-041300 MLP-041301 MLP-041303 MLP-041306 MLP-041307 MLP-041308 MLP-041309 MLP-041310 MLP-041312 MLP-041313 MLP-041320 MLP-041346 MLP-041347 MLP-041348 MLP-041392 MLP-041415 MLP-041428 MLP-041441 MLP-041476 MLP-041479 MLP-041482 MLP-041485 MLP-041490 MLP-041522 MLP-041525 MLP-041526 MLP-041527 MLP-041528 MLP-041530 MLP-041532 MLP-041535 MLP-041536 MLP-041540 MLP-041541 MLP-041548 MLP-041550 MLP-041558 MLP-041616 MLP-041618 MLP-041619 MLP-041620 MLP-041633 MLP-041646 MLP-041666 MLP-041668 MLP-041669 MLP-041715 MLP-041717 MLP-041721 MLP-041727 MLP-041750 MLP-041833 MLP-041840 MLP-041847 MLP-041851 MLP-041906 MLP-041908 MLP-041910 MLP-041917 MLP-041919 MLP-041921 MLP-041924 MLP-041926 MLP-041927 MLP-041928 MLP-041929 MLP-041941 MLP-041943 MLP-041958 MLP-041982 MLP-041984 MLP-041985 MLP-041989 MLP-041993 MLP-041994 MLP-042006 MLP-042007 MLP-042010 MLP-042011 MLP-042013 MLP-042135 MLP-042152 MLP-042157 MLP-042158 MLP-042184 MLP-042192 MLP-042203 MLP-042204 MLP-042219 MLP-042250 MLP-042256 MLP-042260 MLP-042261 MLP-042265 MLP-042266 MLP-042267 MLP-042268 MLP-042269 MLP-042270 MLP-042310 MLP-042314 MLP-042315 MLP-042323 MLP-042355 MLP-042361 MLP-042368 MLP-042388 MLP-042404 MLP-042527 MLP-042556 MLP-042606 MLP-042612 MLP-042627 MLP-042629 MLP-042630 MLP-042633 MLP-042639 MLP-042645 MLP-042648 MLP-042649 MLP-042652 MLP-042666 MLP-042668 MLP-042671 MLP-042675 MLP-042688 MLP-042752 MLP-042757 MLP-042763 MLP-042769 MLP-042802 MLP-042811 MLP-042816 MLP-042817 MLP-042823 MLP-042826 MLP-042880 MLP-042883 MLP-042888 MLP-042895 MLP-042897 MLP-042899 MLP-042925 MLP-042926 MLP-042927 MLP-042928 MLP-042929 MLP-042931 MLP-042932 MLP-042933 MLP-042936 MLP-042937 MLP-042939 MLP-042944 MLP-042945 MLP-042947 MLP-042948 MLP-042949 MLP-042950 MLP-042953 MLP-042954 MLP-042955 MLP-042957 MLP-042960 MLP-042961 MLP-042962 MLP-042968 MLP-042970 MLP-042971 MLP-042973 MLP-042975 MLP-042976 MLP-042981 MLP-042982 MLP-042983 MLP-042985 MLP-042986 MLP-042987 MLP-042988 MLP-042989 MLP-042991 MLP-042994 MLP-043009 MLP-043010 MLP-043012 MLP-043013 MLP-043014 MLP-043015 MLP-043016 MLP-043018 MLP-043019 MLP-043033 MLP-043041 MLP-043053 MLP-043055 MLP-043060 MLP-043061 MLP-043062 MLP-043065 MLP-043067 MLP-043068 MLP-043072 MLP-043074 MLP-043075 MLP-043078 MLP-043083 MLP-043084 MLP-043085 MLP-043086 MLP-043095 MLP-043097 MLP-043098 MLP-043100 MLP-043105 MLP-043106 MLP-043111 MLP-043115 MLP-043121 MLP-043123 MLP-043124 MLP-043186 MLP-043187 MLP-043188 MLP-043189 MLP-043190 MLP-043191 MLP-043192 MLP-043193 MLP-043194 MLP-043196 MLP-043198 MLP-043222 MLP-043242 MLP-043245 MLP-043246 MLP-043247 MLP-043248 MLP-043249 MLP-043250 MLP-043251 MLP-043252 MLP-043253 MLP-043258 MLP-043261 MLP-043262 MLP-043264 MLP-043265 MLP-043266 MLP-043267 MLP-043268 MLP-043269 MLP-043366 MLP-043368 MLP-043369 MLP-043371 MLP-043372 MLP-043374 MLP-043378 MLP-043380 MLP-043382 MLP-043383 MLP-043402 MLP-043403 MLP-043419 MLP-043420 MLP-043421 MLP-043424 MLP-043425 MLP-043427 MLP-043434 MLP-043435 MLP-043437 MLP-043438 MLP-043464 MLP-043466 MLP-043468 MLP-043469 MLP-043471 MLP-043474 MLP-043478 MLP-043480 MLP-043504 MLP-043505 MLP-043506 MLP-043514 MLP-043515 MLP-043565 MLP-043566 MLP-043567 MLP-043569 MLP-043570 MLP-043572 MLP-043573 MLP-043575 MLP-043576 MLP-043577 MLP-043582 MLP-043588 MLP-043589 MLP-043590 MLP-043591 MLP-043592 MLP-043594 MLP-043595 MLP-043596 MLP-043597 MLP-043601 MLP-043602 MLP-043607 MLP-043609 MLP-043610 MLP-043611 MLP-043612 MLP-043616 MLP-043628 MLP-043643 MLP-043644 MLP-043645 MLP-043648 MLP-043650 MLP-043651 MLP-043653 MLP-043654 MLP-043655 MLP-043656 MLP-043659 MLP-043661 MLP-043669 MLP-043670 MLP-043671 MLP-043674 MLP-043696 MLP-043697 MLP-043699 MLP-043700 MLP-043701 MLP-043702 MLP-043714 MLP-043715 MLP-043716 MLP-043717 MLP-043718 MLP-043719 MLP-043720 MLP-043721 MLP-043722 MLP-043723 MLP-044009 MLP-044011 MLP-044016 MLP-044017 MLP-044021 MLP-044027 MLP-044043 MLP-044055 MLP-044056 MLP-044093 MLP-044094 MLP-044096 MLP-044097 MLP-044098 MLP-044099 MLP-044100 MLP-044101 MLP-044102 MLP-044103 MLP-044106 MLP-044110 MLP-044112 MLP-044114 MLP-044115 MLP-044116 MLP-044117 MLP-044118 MLP-044119 MLP-044120 MLP-044121 MLP-044122 MLP-044123 MLP-044124 MLP-044125 MLP-044126 MLP-044127 MLP-044128 MLP-044129 MLP-044130 MLP-044131 MLP-044133 MLP-044134 MLP-044136 MLP-044137 MLP-044140 MLP-044141 MLP-044143 MLP-044144 MLP-044145 MLP-044146 MLP-044147 MLP-044153 MLP-044154 MLP-044156 MLP-044157 MLP-044158 MLP-044159 MLP-044160 MLP-044161 MLP-044163 MLP-044164 MLP-044165 MLP-044166 MLP-044167 MLP-044168 MLP-044169 MLP-044170 MLP-044171 MLP-044172 MLP-044173 MLP-044174 MLP-044176 MLP-044177 MLP-044178 MLP-044179 MLP-044218 MLP-044220 MLP-044222 MLP-021519 MLP-025911 MLP-027675 MLP-029321 MLP-030177 MLP-030949 MLP-031564 MLP-032016 MLP-032017 MLP-032023 MLP-032027 MLP-032031 MLP-032032 MLP-032426 MLP-032429 MLP-032665 MLP-032959 MLP-032960 MLP-032961 MLP-032962 MLP-032963 MLP-032964 MLP-032965 MLP-032966 MLP-032967 MLP-032968 MLP-033044 MLP-033978 MLP-034058 MLP-034060 MLP-034062 MLP-034228 MLP-034263 MLP-034597 MLP-035012 MLP-035583 MLP-035589 MLP-035598 MLP-036591 MLP-037012 MLP-038448 MLP-038775 MLP-038994 MLP-039002 MLP-039075 MLP-039078 MLP-039429 MLP-039553 MLP-039658 MLP-039664 MLP-039666 MLP-039668 MLP-039957 MLP-039958 MLP-039959 MLP-040029 MLP-040046 MLP-040047 MLP-040081 MLP-040114 MLP-040115 MLP-040317 MLP-040320 MLP-040321 MLP-040322 MLP-040323 MLP-040324 MLP-040325 MLP-040326 MLP-040350 MLP-040381 MLP-040384 MLP-040386 MLP-040402 MLP-040403 MLP-040404 MLP-040405 MLP-040413 MLP-040414 MLP-040963 MLP-041219 MLP-041220 MLP-041240 MLP-041506 MLP-041507 MLP-041508 MLP-041509 MLP-041510 MLP-041511 MLP-041512 MLP-041513 MLP-041539 MLP-041554 MLP-041556 MLP-041557 MLP-041560 MLP-041562 MLP-041565 MLP-041733 MLP-041734 MLP-041735 MLP-041834 MLP-042062 MLP-042066 MLP-042074 MLP-042080 MLP-042205 MLP-042206 MLP-042207 MLP-042208 MLP-042210 MLP-042211 MLP-042212 MLP-042469 MLP-042472 MLP-042473 MLP-042474 MLP-042475 MLP-042476 MLP-042477 MLP-042480 MLP-042664 MLP-042818 MLP-042884 MLP-042885 MLP-043032 MLP-043036 MLP-043037 MLP-043039 MLP-043040 MLP-043118 MLP-043126 MLP-043128 MLP-043144 MLP-043202 MLP-043205 MLP-043211 MLP-043257 MLP-043423 MLP-043485 MLP-043486 MLP-043487 MLP-043488 MLP-043489 MLP-043490 MLP-043491 MLP-043492 MLP-043493 MLP-043494 MLP-043496 MLP-043622 MLP-043691 MLP-043692 MLP-043693 MLP-043694 MLP-043710 MLP-043711 MLP-043712 MLP-044135 MLP-044139