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Product Recall Tracker

Thoratec Corp. Recall 94232

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

Thoratec Corp. Recall 94232 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1692-2024
Event ID94232
Event DescriptionThoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Product TypeDevices
DistributionWorldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, & WV; and OUS (foreign) countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, and Uzbekistan.
Quantity882 units
Recall ReasonPotential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Device Classification20240508
Device Code InfoUDI: 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
Center Classification Date20240501
Recall Initiation Date20240301
Recalling FirmThoratec Corp.
Initial Notification E-Mail
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