Class 1 Device Recall HeartMate II Left Ventricular Assist System

• Date Initiated by Firm: February 19, 2024
• Date Posted: March 22, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1300-2024
• Recall Event ID: 93963
• PMA Number: P060040
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS Implant Kit, OUS REF 102139 2. HeartMate II LVAS Implant Kit, US REF 1355 3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries.
• Code Information: HeartMate II LVAS Model Numbers: 1. 103393 (cannot be implanted without a LVAD) 2. 106015 (US) 3. 106016 (OUS) Update (February 14, 2024) HeartMate II LVAS: 1. 102139 (OUS), includes Unsealed Outflow Graft with Bend Relief 2. 1355 (US), includes Unsealed Outflow Graft with Bend Relief 3. 103695 (US), includes Unsealed Outflow Graft with Bend Relief 4. 103693 (OUS), includes Unsealed Outflow Graft with Bend Relief 5. 104911 (US) 6. 104912 (OUS) 7. 107801 (US), does not include Outflow Graft 8. 103695-CAN, includes Unsealed Outflow Graft with Bend Relief 9. 104911JPN 10. 106515OUS UDI-DI codes: HeartMate II LVAS: 1. 00813024010807 2. 00813024011224 3. 00813024011231 Update (February 14, 2024) HeartMate II LVAS: 1. N/A 2. 00813024010005 3. 00813024010616 4. 00813024010623 5. 00813024011170 6. 00813024010821 7. 00813024011996 8. N/A 9. 00813024011682 10. 00813024011682 Serial Numbers: US VAD-0357 VAD-0638 VAD-10113 VAD-10162 VAD-10198 VAD-10418 VAD-10543 VAD-10634 VAD-10708 VAD-10734 VAD-10749 VAD-10808 VAD-10840 VAD-10995 VAD-11099 VAD-11104 VAD-11131 VAD-11134 VAD-11241 VAD-11250 VAD-11343 VAD-11369 VAD-11488 VAD-11545 VAD-11602 VAD-11866 VAD-11937 VAD-12055 VAD-12075 VAD-12169 VAD-12174 VAD-12280 VAD-12333 VAD-12344 VAD-12440 VAD-12449 VAD-12454 VAD-12516 VAD-12622 VAD-12641 VAD-12644 VAD-12690 VAD-12756 VAD-12806 VAD-12909 VAD-12943 VAD-13002 VAD-13011 VAD-13094 VAD-13096 VAD-13148 VAD-13161 VAD-13171 VAD-13232 VAD-13263 VAD-13304 VAD-13385 VAD-13388 VAD-13416 VAD-13464 VAD-13488 VAD-13543 VAD-13568 VAD-13586 VAD-13639 VAD-13647 VAD-13725 VAD-13735 VAD-13797 VAD-13844 VAD-13862 VAD-13896 VAD-13914 VAD-13915 VAD-13922 VAD-13924 VAD-13961 VAD-13988 VAD-13993 VAD-14038 VAD-14104 VAD-14176 VAD-14179 VAD-14235 VAD-14261 VAD-14304 VAD-14312 VAD-14336 VAD-14347 VAD-14383 VAD-14387 VAD-14456 VAD-14480 VAD-14493 VAD-14507 VAD-14511 VAD-14525 VAD-14534 VAD-14535 VAD-14562 VAD-14576 VAD-14578 VAD-14662 VAD-14690 VAD-14699 VAD-14706 VAD-14743 VAD-14752 VAD-14775 VAD-14778 VAD-14884 VAD-14932 VAD-14938 VAD-14955 VAD-14974 VAD-15009 VAD-15017 VAD-15018 VAD-15074 VAD-15079 VAD-15126 VAD-15127 VAD-15129 VAD-15166 VAD-15192 VAD-15219 VAD-15225 VAD-15239 VAD-15270 VAD-15350 VAD-15365 VAD-15401 VAD-15422 VAD-15424 VAD-15432 VAD-15452 VAD-15462 VAD-15513 VAD-15527 VAD-15539 VAD-15584 VAD-15609 VAD-15624 VAD-15627 VAD-15639 VAD-15815 VAD-15817 VAD-15844 VAD-15847 VAD-15898 VAD-15917 VAD-16008 VAD-16060 VAD-16068 VAD-16083 VAD-16222 VAD-16233 VAD-16244 VAD-16270 VAD-16290 VAD-16411 VAD-16436 VAD-16442 VAD-16511 VAD-16514 VAD-16515 VAD-16520 VAD-16536 VAD-16604 VAD-16665 VAD-16668 VAD-16682 VAD-16727 VAD-16804 VAD-16838 VAD-16840 VAD-16846 VAD-16854 VAD-16905 VAD-16928 VAD-16946 VAD-17001 VAD-17016 VAD-17020 VAD-17036 VAD-17045 VAD-17055 VAD-17061 VAD-17073 VAD-17078 VAD-17099 VAD-17111 VAD-17113 VAD-17133 VAD-17185 VAD-17192 VAD-17194 VAD-17210 VAD-17223 VAD-17225 VAD-17239 VAD-17242 VAD-17255 VAD-17260 VAD-17275 VAD-17309 VAD-17321 VAD-17322 VAD-17387 VAD-17400 VAD-17405 VAD-17428 VAD-17437 VAD-17452 VAD-17474 VAD-17476 VAD-17501 VAD-17516 VAD-17525 VAD-17532 VAD-17540 VAD-17542 VAD-17556 VAD-17572 VAD-17579 VAD-17619 VAD-17645 VAD-17686 VAD-17692 VAD-17728 VAD-1773 VAD-17734 VAD-17738 VAD-17740 VAD-17763 VAD-17784 VAD-17806 VAD-17808 VAD-17824 VAD-17833 VAD-17855 VAD-17863 VAD-17871 VAD-17872 VAD-17877 VAD-17896 VAD-18006 VAD-18014 VAD-18024 VAD-18054 VAD-18056 VAD-18067 VAD-18070 VAD-18084 VAD-18098 VAD-18114 VAD-18123 VAD-18133 VAD-18138 VAD-18165 VAD-18186 VAD-18211 VAD-18218 VAD-18224 VAD-18244 VAD-18254 VAD-18264 VAD-18268 VAD-18276 VAD-18279 VAD-18284 VAD-18290 VAD-18304 VAD-18309 VAD-18316 VAD-18326 VAD-18363 VAD-18369 VAD-18381 VAD-18386 VAD-18427 VAD-18433 VAD-18441 VAD-18466 VAD-18519 VAD-18520 VAD-18522 VAD-18523 VAD-18533 VAD-18536 VAD-18538 VAD-18544 VAD-18548 VAD-18552 VAD-18559 VAD-18564 VAD-18565 VAD-18569 VAD-18583 VAD-18591 VAD-18593 VAD-18633 VAD-18642 VAD-18654 VAD-18657 VAD-18664 VAD-18666 VAD-18669 VAD-18690 VAD-18693 VAD-18695 VAD-18711 VAD-18718 VAD-18721 VAD-18722 VAD-18732 VAD-18745 VAD-18746 VAD-18752 VAD-18768 VAD-18770 VAD-18788 VAD-18800 VAD-18802 VAD-18804 VAD-18822 VAD-18823 VAD-18825 VAD-18826 VAD-18835 VAD-18842 VAD-18850 VAD-18873 VAD-18874 VAD-18877 VAD-18881 VAD-18900 VAD-18912 VAD-18943 VAD-18964 VAD-18965 VAD-18973 VAD-18979 VAD-18988 VAD-19001 VAD-19013 VAD-19016 VAD-19022 VAD-19029 VAD-19050 VAD-19106 VAD-19118 VAD-19120 VAD-19131 VAD-19132 VAD-19145 VAD-19154 VAD-19167 VAD-19169 VAD-19179 VAD-19184 VAD-19194 VAD-19198 VAD-19203 VAD-19206 VAD-19211 VAD-19235 VAD-19237 VAD-19238 VAD-19250 VAD-19254 VAD-19258 VAD-19264 VAD-19272 VAD-19277 VAD-19284 VAD-19293 VAD-19311 VAD-19313 VAD-19326 VAD-19336 VAD-19337 VAD-19340 VAD-19349 VAD-19354 VAD-19355 VAD-19362 VAD-19414 VAD-19428 VAD-19447 VAD-19467 VAD-19481 VAD-19497 VAD-19515 VAD-19516 VAD-19524 VAD-1953 VAD-19548 VAD-19559 VAD-19571 VAD-19572 VAD-19574 VAD-19589 VAD-19593 VAD-19601 VAD-19606 VAD-19611 VAD-19613 VAD-19620 VAD-19625 VAD-19643 VAD-19650 VAD-19658 VAD-19733 VAD-19741 VAD-19749 VAD-19760 VAD-19763 VAD-19767 VAD-19776 VAD-19780 VAD-19788 VAD-19814 VAD-19822 VAD-19823 VAD-19828 VAD-19830 VAD-19837 VAD-19853 VAD-19867 VAD-19868 VAD-19869 VAD-19876 VAD-19894 VAD-19900 VAD-19907 VAD-19918 VAD-19921 VAD-19923 VAD-19937 VAD-19940 VAD-19954 VAD-19958 VAD-19959 VAD-19969 VAD-19973 VAD-19978 VAD-19981 VAD-19992 VAD-20000 VAD-20004 VAD-20008 VAD-20012 VAD-20015 VAD-20020 VAD-20028 VAD-20034 VAD-20040 VAD-20043 VAD-20046 VAD-20047 VAD-20094 VAD-20129 VAD-20140 VAD-20157 VAD-20175 VAD-20177 VAD-20186 VAD-20209 VAD-20241 VAD-20243 VAD-20247 VAD-20248 VAD-20249 VAD-20266 VAD-20267 VAD-20268 VAD-20272 VAD-20283 VAD-20306 VAD-20323 VAD-20326 VAD-20327 VAD-20332 VAD-20340 VAD-20343 VAD-20354 VAD-20359 VAD-20363 VAD-20372 VAD-20384 VAD-20385 VAD-20387 VAD-20397 VAD-20404 VAD-20410 VAD-20411 VAD-20414 VAD-20423 VAD-20433 VAD-20438 VAD-20451 VAD-20464 VAD-20465 VAD-20470 VAD-20480 VAD-20481 VAD-20483 VAD-20484 VAD-20495 VAD-20499 VAD-20507 VAD-20517 VAD-20522 VAD-20526 VAD-20537 VAD-20539 VAD-20562 VAD-20568 VAD-20574 VAD-20575 VAD-20585 VAD-20587 VAD-20589 VAD-20592 VAD-20593 VAD-20594 VAD-20595 VAD-20606 VAD-20608 VAD-20611 VAD-20615 VAD-20623 VAD-20626 VAD-20627 VAD-20634 VAD-20638 VAD-20649 VAD-20652 VAD-20662 VAD-20665 VAD-20669 VAD-20683 VAD-20689 VAD-20691 VAD-20695 VAD-20704 VAD-20712 VAD-20713 VAD-20716 VAD-20725 VAD-20732 VAD-20736 VAD-20737 VAD-20738 VAD-20740 VAD-20742 VAD-20746 VAD-20747 VAD-20748 VAD-20752 VAD-20753 VAD-20754 VAD-20759 VAD-20765 VAD-20769 VAD-20778 VAD-20783 VAD-20785 VAD-20796 VAD-20800 VAD-20808 VAD-20831 VAD-20837 VAD-20843 VAD-20847 VAD-20857 VAD-20871 VAD-20873 VAD-20875 VAD-20876 VAD-20901 VAD-20903 VAD-20904 VAD-20907 VAD-20908 VAD-20909 VAD-20911 VAD-20913 VAD-20914 VAD-20928 VAD-20932 VAD-20937 VAD-20941 VAD-20942 VAD-20944 VAD-20953 VAD-20956 VAD-20971 VAD-20982 VAD-20994 VAD-21006 VAD-21007 VAD-21015 VAD-21020 VAD-21021 VAD-21026 VAD-21036 VAD-21040 VAD-21043 VAD-21045 VAD-21079 VAD-21084 VAD-21093 VAD-21107 VAD-21115 VAD-21121 VAD-21135 VAD-21143 VAD-21145 VAD-21151 VAD-21154 VAD-21166 VAD-2118 VAD-21181 VAD-21183 VAD-21189 VAD-21190 VAD-21191 VAD-21192 VAD-21198 VAD-21202 VAD-21203 VAD-21209 VAD-21222 VAD-21227 VAD-21228 VAD-21241 VAD-21248 VAD-21255 VAD-21258 VAD-21260 VAD-21261 VAD-21262 VAD-21265 VAD-21280 VAD-21321 VAD-21322 VAD-21325 VAD-21340 VAD-21349 VAD-21350 VAD-21351 VAD-21352 VAD-21355 VAD-21356 VAD-21367 VAD-21369 VAD-21373 VAD-21376 VAD-21382 VAD-21385 VAD-21392 VAD-21395 VAD-21403 VAD-21404 VAD-21408 VAD-21416 VAD-21420 VAD-21422 VAD-21426 VAD-21431 VAD-21432 VAD-21437 VAD-21443 VAD-21445 VAD-21447 VAD-21454 VAD-21456 VAD-21466 VAD-21467 VAD-21472 VAD-21487 VAD-2418 VAD-2495 VAD-2593 VAD-2661 VAD-2806 VAD-2949 VAD-3178 VAD-3195 VAD-3304 VAD-3351 VAD-3456 VAD-3478 VAD-3498 VAD-3577 VAD-3623 VAD-3627 VAD-4176 VAD-4276 VAD-4584 VAD-4619 VAD-4813 VAD-4837 VAD-50132 VAD-50146 VAD-50206 VAD-50326 VAD-50336 VAD-50353 VAD-5037 VAD-50371 VAD-50391 VAD-50439 VAD-50485 VAD-50487 VAD-50745 VAD-50821 VAD-50998 VAD-51037 VAD-51054 VAD-51085 VAD-51140 VAD-51201 VAD-51329 VAD-51355 VAD-51438 VAD-51467 VAD-51575 VAD-51658 VAD-5168 VAD-51708 VAD-51747 VAD-51814 VAD-51855 VAD-51927 VAD-51983 VAD-52024 VAD-52062 VAD-52215 VAD-52291 VAD-52350 VAD-52571 VAD-52627 VAD-52687 VAD-52695 VAD-52806 VAD-52952 VAD-52970 VAD-53000 VAD-53007 VAD-53230 VAD-53303 VAD-53351 VAD-53375 VAD-53404 VAD-53426 VAD-53451 VAD-5349 VAD-53546 VAD-53584 VAD-53729 VAD-53780 VAD-53882 VAD-54018 VAD-54019 VAD-54060 VAD-54070 VAD-54095 VAD-54105 VAD-54193 VAD-54309 VAD-54318 VAD-54348 VAD-54363 VAD-54423 VAD-54458 VAD-54525 VAD-54546 VAD-54560 VAD-54592 VAD-54641 VAD-54646 VAD-54781 VAD-54812 VAD-54842 VAD-54881 VAD-54981 VAD-54989 VAD-55176 VAD-55192 VAD-55214 VAD-55232 VAD-55243 VAD-55307 VAD-55316 VAD-55336 VAD-55345 VAD-55438 VAD-5546 VAD-55523 VAD-55552 VAD-55580 VAD-55594 VAD-55607 VAD-55611 VAD-55617 VAD-55629 VAD-55702 VAD-55710 VAD-55718 VAD-55798 VAD-55908 VAD-56010 VAD-56034 VAD-56081 VAD-56139 VAD-56154 VAD-56232 VAD-56328 VAD-56438 VAD-56454 VAD-56533 VAD-56561 VAD-56615 VAD-56636 VAD-56708 VAD-56709 VAD-56745 VAD-56769 VAD-56797 VAD-56818 VAD-56828 VAD-56867 VAD-56906 VAD-57101 VAD-57108 VAD-57117 VAD-57120 VAD-57127 VAD-57160 VAD-57217 VAD-57225 VAD-57233 VAD-57255 VAD-57273 VAD-57314 VAD-57367 VAD-5742 VAD-57441 VAD-57453 VAD-57473 VAD-57486 VAD-57511 VAD-57565 VAD-57580 VAD-57605 VAD-57664 VAD-57667 VAD-57675 VAD-57697 VAD-57735 VAD-57746 VAD-57767 VAD-57823 VAD-57834 VAD-57854 VAD-57931 VAD-57979 VAD-58015 VAD-58049 VAD-58053 VAD-58127 VAD-58140 VAD-58162 VAD-58164 VAD-58166 VAD-58172 VAD-58186 VAD-58238 VAD-58261 VAD-58283 VAD-58312 VAD-58313 VAD-58314 VAD-58338 VAD-58368 VAD-58383 VAD-58387 VAD-58426 VAD-58430 VAD-58483 VAD-58485 VAD-58492 VAD-58554 VAD-58575 VAD-58578 VAD-58597 VAD-58655 VAD-58661 VAD-58668 VAD-58676 VAD-58684 VAD-58701 VAD-58705 VAD-58718 VAD-58728 VAD-58730 VAD-58755 VAD-58759 VAD-58772 VAD-58776 VAD-58843 VAD-58852 VAD-58871 VAD-58904 VAD-58915 VAD-58916 VAD-58961 VAD-58974 VAD-58997 VAD-59004 VAD-59008 VAD-59011 VAD-59014 VAD-59015 VAD-59034 VAD-59059 VAD-59063 VAD-59089 VAD-59144 VAD-59154 VAD-59168 VAD-59196 VAD-59202 VAD-59204 VAD-59213 VAD-59214 VAD-59349 VAD-59353 VAD-59373 VAD-59398 VAD-59404 VAD-59406 VAD-59408 VAD-59410 VAD-59442 VAD-59474 VAD-59506 VAD-59507 VAD-59514 VAD-59536 VAD-59556 VAD-59587 VAD-59610 VAD-59626 VAD-59640 VAD-59641 VAD-59654 VAD-59708 VAD-59713 VAD-59750 VAD-59771 VAD-59823 VAD-59841 VAD-59879 VAD-59890 VAD-59934 VAD-59949 VAD-59951 VAD-59956 VAD-59963 VAD-59968 VAD-59979 VAD-59980 VAD-59995 VAD-59997 VAD-60006 VAD-60011 VAD-60030 VAD-60053 VAD-60061 VAD-60065 VAD-60066 VAD-60084 VAD-60109 VAD-60150 VAD-60183 VAD-60187 VAD-60191 VAD-60209 VAD-60243 VAD-60262 VAD-60270 VAD-60281 VAD-60286 VAD-60288 VAD-60296 VAD-60343 VAD-60358 VAD-60369 VAD-60370 VAD-60396 VAD-60407 VAD-60418 VAD-60444 VAD-60454 VAD-60456 VAD-60481 VAD-60504 VAD-60505 VAD-60510 VAD-60511 VAD-60530 VAD-6054 VAD-60588 VAD-60596 VAD-60612 VAD-60615 VAD-60619 VAD-60622 VAD-60631 VAD-60650 VAD-60652 VAD-60665 VAD-60668 VAD-60682 VAD-60688 VAD-60692 VAD-60693 VAD-60701 VAD-60711 VAD-60717 VAD-60730 VAD-60746 VAD-60753 VAD-60765 VAD-60779 VAD-60786 VAD-60798 VAD-60818 VAD-60834 VAD-60849 VAD-60852 VAD-60855 VAD-60872 VAD-60874 VAD-60876 VAD-60881 VAD-60882 VAD-60903 VAD-60918 VAD-60936 VAD-60947 VAD-60959 VAD-60966 VAD-60990 VAD-61003 VAD-61013 VAD-61021 VAD-61025 VAD-61033 VAD-61037 VAD-61040 VAD-6116 VAD-61258 VAD-61287 VAD-61293 VAD-61310 VAD-61334 VAD-61353 VAD-61359 VAD-61444 VAD-61450 VAD-61467 VAD-61469 VAD-61476 VAD-61485 VAD-61512 VAD-61517 VAD-61518 VAD-61521 VAD-61522 VAD-61539 VAD-61542 VAD-61543 VAD-61545 VAD-61549 VAD-61559 VAD-61563 VAD-61588 VAD-6160 VAD-61638 VAD-61641 VAD-61658 VAD-61663 VAD-61678 VAD-61680 VAD-61684 VAD-61691 VAD-61701 VAD-61712 VAD-61718 VAD-61735 VAD-61762 VAD-61774 VAD-61776 VAD-61790 VAD-61803 VAD-61814 VAD-61839 VAD-61847 VAD-61848 VAD-61882 VAD-61883 VAD-61900 VAD-61908 VAD-61932 VAD-61933 VAD-61987 VAD-62007 VAD-62036 VAD-62081 VAD-62087 VAD-62101 VAD-62102 VAD-62124 VAD-62142 VAD-62144 VAD-62155 VAD-62167 VAD-62199 VAD-62203 VAD-62214 VAD-62218 VAD-62221 VAD-62223 VAD-62228 VAD-62232 VAD-62238 VAD-62240 VAD-62241 VAD-62246 VAD-62249 VAD-62254 VAD-62261 VAD-62269 VAD-62270 VAD-62403 VAD-62409 VAD-62410 VAD-62416 VAD-62423 VAD-62481 VAD-62503 VAD-62504 VAD-62505 VAD-62508 VAD-62514 VAD-62535 VAD-62540 VAD-62541 VAD-62574 VAD-62578 VAD-62591 VAD-62595 VAD-62649 VAD-62650 VAD-62651 VAD-62700 VAD-62714 VAD-62718 VAD-62728 VAD-62733 VAD-62741 VAD-62745 VAD-62759 VAD-62760 VAD-62764 VAD-62769 VAD-62774 VAD-62788 VAD-62795 VAD-62801 VAD-62802 VAD-62810 VAD-62814 VAD-62818 VAD-62829 VAD-62833 VAD-62835 VAD-62846 VAD-62854 VAD-62860 VAD-62861 VAD-62889 VAD-62922 VAD-62929 VAD-62935 VAD-62936 VAD-62939 VAD-62940 VAD-62968 VAD-62976 VAD-62978 VAD-62982 VAD-62989 VAD-62992 VAD-62998 VAD-63000 VAD-63001 VAD-63004 VAD-63006 VAD-63009 VAD-63015 VAD-63017 VAD-63018 VAD-63028 VAD-63032 VAD-63038 VAD-63041 VAD-63043 VAD-63046 VAD-63053 VAD-63054 VAD-63070 VAD-63091 VAD-63093 VAD-63099 VAD-63102 VAD-63133 VAD-63138 VAD-63151 VAD-63170 VAD-63171 VAD-63172 VAD-63187 VAD-63194 VAD-63205 VAD-63210 VAD-63215 VAD-63216 VAD-63242 VAD-63251 VAD-63253 VAD-63255 VAD-63256 VAD-63285 VAD-63287 VAD-63290 VAD-63306 VAD-63307 VAD-63312 VAD-63315 VAD-63318 VAD-63323 VAD-63326 VAD-63327 VAD-63369 VAD-63370 VAD-63378 VAD-63384 VAD-63394 VAD-63398 VAD-63399 VAD-63401 VAD-63412 VAD-63580 VAD-6406 VAD-6505 VAD-6532 VAD-6572 VAD-6617 VAD-6673 VAD-6698 VAD-6794 VAD-7061 VAD-7157 VAD-7490 VAD-7843 VAD-7975 VAD-8015 VAD-8154 VAD-8273 VAD-8490 VAD-8517 VAD-8591 VAD-9069 VAD-9082 VAD-9107 VAD-9187 VAD-9235 VAD-9370 VAD-9395 VAD-9474 VAD-9671 VAD-9738 VAD-9786 VAD-9829 VAD-9850 VAD-9925 VAD-9937 OUS VAD-10474 VAD-10953 VAD-11081 VAD-11251 VAD-12042 VAD-12648 VAD-12820 VAD-12907 VAD-12912 VAD-12981 VAD-13222 VAD-13294 VAD-13562 VAD-13618 VAD-13700 VAD-13705 VAD-13706 VAD-13766 VAD-13785 VAD-13954 VAD-14379 VAD-14468 VAD-14499 VAD-14529 VAD-14645 VAD-14708 VAD-14950 VAD-15047 VAD-15109 VAD-15223 VAD-15333 VAD-15366 VAD-15374 VAD-15406 VAD-15702 VAD-15724 VAD-15879 VAD-15890 VAD-16037 VAD-16045 VAD-16052 VAD-16054 VAD-16056 VAD-16081 VAD-16090 VAD-16096 VAD-16121 VAD-16302 VAD-16308 VAD-16339 VAD-16437 VAD-16440 VAD-16501 VAD-16526 VAD-16560 VAD-16566 VAD-16569 VAD-16583 VAD-16615 VAD-16630 VAD-16650 VAD-16686 VAD-16688 VAD-16707 VAD-16750 VAD-16799 VAD-16882 VAD-16884 VAD-1690 VAD-16919 VAD-16959 VAD-17013 VAD-17041 VAD-17057 VAD-17160 VAD-17190 VAD-17247 VAD-17248 VAD-17258 VAD-17276 VAD-17280 VAD-17329 VAD-17357 VAD-17409 VAD-17496 VAD-17514 VAD-17620 VAD-17630 VAD-17711 VAD-17768 VAD-17775 VAD-17881 VAD-17883 VAD-1795 VAD-18182 VAD-18201 VAD-18277 VAD-18303 VAD-18428 VAD-18467 VAD-18498 VAD-18864 VAD-18892 VAD-18895 VAD-19063 VAD-19068 VAD-19166 VAD-19195 VAD-19209 VAD-19231 VAD-19291 VAD-19302 VAD-19316 VAD-19319 VAD-19387 VAD-19449 VAD-19450 VAD-19491 VAD-19505 VAD-19507 VAD-19526 VAD-19579 VAD-19581 VAD-19651 VAD-19663 VAD-19664 VAD-19674 VAD-19677 VAD-19699 VAD-19709 VAD-19714 VAD-19725 VAD-19736 VAD-19744 VAD-19752 VAD-19753 VAD-19811 VAD-19819 VAD-19835 VAD-20033 VAD-20082 VAD-20307 VAD-20402 VAD-20530 VAD-20550 VAD-20591 VAD-20677 VAD-20678 VAD-20711 VAD-20824 VAD-20919 VAD-20993 VAD-21008 VAD-21009 VAD-21010 VAD-21012 VAD-21059 VAD-21063 VAD-21066 VAD-21069 VAD-21072 VAD-21098 VAD-21104 VAD-21105 VAD-21110 VAD-21118 VAD-21119 VAD-21120 VAD-21136 VAD-21138 VAD-21140 VAD-21157 VAD-21159 VAD-21175 VAD-21185 VAD-21186 VAD-21187 VAD-21195 VAD-21237 VAD-21242 VAD-21297 VAD-21298 VAD-21317 VAD-21354 VAD-21357 VAD-21379 VAD-21405 VAD-21452 VAD-21469 VAD-21470 VAD-21483 VAD-2313 VAD-3606 VAD-50265 VAD-50418 VAD-50924 VAD-51184 VAD-51275 VAD-51288 VAD-51327 VAD-51515 VAD-51516 VAD-52214 VAD-52260 VAD-52264 VAD-52444 VAD-52501 VAD-52508 VAD-52852 VAD-52908 VAD-53018 VAD-53025 VAD-53468 VAD-53542 VAD-53627 VAD-53924 VAD-54047 VAD-54162 VAD-54241 VAD-54664 VAD-54827 VAD-54887 VAD-55069 VAD-55075 VAD-55079 VAD-55225 VAD-55236 VAD-55251 VAD-55289 VAD-55330 VAD-55664 VAD-55721 VAD-55729 VAD-55840 VAD-55872 VAD-56259 VAD-56267 VAD-56276 VAD-56395 VAD-56402 VAD-56447 VAD-56632 VAD-56690 VAD-56707 VAD-56736 VAD-56785 VAD-56857 VAD-56931 VAD-56943 VAD-56956 VAD-57067 VAD-57082 VAD-57189 VAD-57192 VAD-57199 VAD-57241 VAD-57317 VAD-57343 VAD-57380 VAD-57392 VAD-57396 VAD-57414 VAD-57420 VAD-57496 VAD-57519 VAD-57551 VAD-57627 VAD-57629 VAD-57693 VAD-57777 VAD-57804 VAD-57882 VAD-57888 VAD-57946 VAD-57996 VAD-58030 VAD-58040 VAD-58135 VAD-58153 VAD-58245 VAD-58424 VAD-58433 VAD-58462 VAD-58571 VAD-58700 VAD-58737 VAD-58834 VAD-58840 VAD-58845 VAD-58848 VAD-58851 VAD-58857 VAD-58873 VAD-58956 VAD-59024 VAD-59045 VAD-59071 VAD-59104 VAD-59114 VAD-59124 VAD-59127 VAD-59151 VAD-59222 VAD-59243 VAD-59277 VAD-59322 VAD-59451 VAD-59473 VAD-59498 VAD-59517 VAD-59598 VAD-59716 VAD-59717 VAD-59808 VAD-59870 VAD-59940 VAD-60019 VAD-60048 VAD-60354 VAD-60401 VAD-60433 VAD-60477 VAD-60482 VAD-60540 VAD-60566 VAD-60609 VAD-60689 VAD-60694 VAD-60760 VAD-61036 VAD-61047 VAD-61075 VAD-61254 VAD-61289 VAD-61535 VAD-61585 VAD-61729 VAD-61867 VAD-61896 VAD-62011 VAD-62068 VAD-62159 VAD-62224 VAD-62227 VAD-62267 VAD-62272 VAD-62274 VAD-62283 VAD-62290 VAD-62297 VAD-62301 VAD-62303 VAD-62314 VAD-62326 VAD-62337 VAD-62345 VAD-62347 VAD-62349 VAD-62353 VAD-62355 VAD-62362 VAD-62375 VAD-62380 VAD-62381 VAD-62385 VAD-62386 VAD-62388 VAD-62389 VAD-62391 VAD-62392 VAD-62393 VAD-62425 VAD-62428 VAD-62433 VAD-62434 VAD-62437 VAD-62438 VAD-62439 VAD-62455 VAD-62457 VAD-62460 VAD-62462 VAD-62463 VAD-62465 VAD-62466 VAD-62468 VAD-62469 VAD-62485 VAD-62487 VAD-62490 VAD-62491 VAD-62494 VAD-62495 VAD-62517 VAD-62520 VAD-62523 VAD-62527 VAD-62529 VAD-62548 VAD-62554 VAD-62555 VAD-62602 VAD-62603 VAD-62609 VAD-63115 VAD-63119 VAD-63120 VAD-63136 VAD-63145 VAD-63153 VAD-63160 VAD-63228 VAD-63230 VAD-63263 VAD-63266 VAD-63270 VAD-63271 VAD-63274 VAD-63276 VAD-63279 VAD-63280 VAD-63284 VAD-63302 VAD-63304 VAD-63313 VAD-63321 VAD-63324 VAD-63328 VAD-63349 VAD-63350 VAD-63351 VAD-63353 VAD-63354 VAD-63356 VAD-63357 VAD-63359 VAD-63360 VAD-63363 VAD-63364 VAD-63375 VAD-63376 VAD-63428 VAD-63430 VAD-63431 VAD-63432 VAD-63433 VAD-63434 VAD-63438 VAD-6387 VAD-6516 VAD-6955 VAD-7443 VAD-7725 VAD-7786 VAD-8689 VAD-9130 VAD-9330 VAD-9846 VAD-9940 Updated 02/14/2024: U.S. VAD-0357 VAD-0638 VAD-10113 VAD-10162 VAD-10198 VAD-10418 VAD-10543 VAD-10634 VAD-10708 VAD-10734 VAD-10749 VAD-10808 VAD-10840 VAD-10995 VAD-11099 VAD-11104 VAD-11131 VAD-11134 VAD-11241 VAD-11250 VAD-11343 VAD-11369 VAD-11488 VAD-11545 VAD-11602 VAD-11866 VAD-11937 VAD-12055 VAD-12075 VAD-12169 VAD-12174 VAD-12280 VAD-12333 VAD-12344 VAD-12440 VAD-12449 VAD-12454 VAD-12516 VAD-12622 VAD-12641 VAD-12644 VAD-12690 VAD-12756 VAD-12806 VAD-12909 VAD-12943 VAD-13002 VAD-13011 VAD-13094 VAD-13096 VAD-13148 VAD-13161 VAD-13171 VAD-13232 VAD-13263 VAD-13304 VAD-13385 VAD-13388 VAD-13416 VAD-13464 VAD-13488 VAD-13568 VAD-13586 VAD-13797 VAD-14383 VAD-15432 VAD-16854 VAD-17185 VAD-17239 VAD-17542 VAD-1773 VAD-18024 VAD-18583 VAD-18800 VAD-19106 VAD-19497 VAD-1953 VAD-19611 VAD-19749 VAD-19822 VAD-20034 VAD-20323 VAD-20384 VAD-20385 VAD-20464 VAD-20480 VAD-20484 VAD-20562 VAD-20742 VAD-20747 VAD-20752 VAD-20753 VAD-20754 VAD-20759 VAD-20765 VAD-20769 VAD-20785 VAD-20831 VAD-20837 VAD-20871 VAD-20928 VAD-20937 VAD-20941 VAD-20942 VAD-20944 VAD-20953 VAD-21006 VAD-21007 VAD-21045 VAD-21084 VAD-21093 VAD-21135 VAD-21166 VAD-2118 VAD-21181 VAD-21183 VAD-21190 VAD-21191 VAD-21192 VAD-21321 VAD-21322 VAD-21367 VAD-21369 VAD-21373 VAD-21376 VAD-21382 VAD-21431 VAD-21432 VAD-21437 VAD-21445 VAD-21454 VAD-21456 VAD-21472 VAD-21487 VAD-2418 VAD-2495 VAD-2593 VAD-2661 VAD-2806 VAD-2949 VAD-3178 VAD-3195 VAD-3304 VAD-3351 VAD-3456 VAD-3478 VAD-3498 VAD-3577 VAD-3623 VAD-3627 VAD-4176 VAD-4276 VAD-4584 VAD-4619 VAD-4813 VAD-4837 VAD-50132 VAD-50146 VAD-50206 VAD-50326 VAD-50336 VAD-50353 VAD-5037 VAD-50371 VAD-50391 VAD-50439 VAD-50485 VAD-50487 VAD-50745 VAD-50821 VAD-50998 VAD-51037 VAD-51054 VAD-51085 VAD-51140 VAD-51201 VAD-51329 VAD-51355 VAD-51438 VAD-51467 VAD-51575 VAD-51658 VAD-5168 VAD-51708 VAD-51747 VAD-51814 VAD-51855 VAD-51927 VAD-51983 VAD-52024 VAD-52062 VAD-52215 VAD-52291 VAD-52350 VAD-52571 VAD-52627 VAD-52687 VAD-52695 VAD-52806 VAD-52952 VAD-52970 VAD-53000 VAD-53007 VAD-53230 VAD-53303 VAD-53351 VAD-53375 VAD-53404 VAD-53426 VAD-53451 VAD-5349 VAD-53546 VAD-53584 VAD-53729 VAD-53780 VAD-53882 VAD-54018 VAD-54019 VAD-54060 VAD-54070 VAD-54095 VAD-54105 VAD-54193 VAD-54309 VAD-54318 VAD-54348 VAD-54423 VAD-54458 VAD-54525 VAD-54546 VAD-54592 VAD-54641 VAD-54646 VAD-5546 VAD-55908 VAD-5742 VAD-57834 VAD-59144 VAD-59168 VAD-60369 VAD-60370 VAD-60454 VAD-60456 VAD-6054 VAD-60588 VAD-60622 VAD-60730 VAD-60855 VAD-60881 VAD-60882 VAD-61040 VAD-6116 VAD-61521 VAD-61543 VAD-61545 VAD-6160 VAD-61663 VAD-62087 VAD-62218 VAD-62221 VAD-62223 VAD-62238 VAD-62240 VAD-62241 VAD-62246 VAD-62505 VAD-62591 VAD-62649 VAD-62650 VAD-62810 VAD-62814 VAD-62889 VAD-63070 VAD-63138 VAD-63172 VAD-63205 VAD-63210 VAD-63242 VAD-63307 VAD-63312 VAD-63315 VAD-63326 VAD-63327 VAD-63378 VAD-63394 VAD-63412 VAD-6406 VAD-6505 VAD-6532 VAD-6572 VAD-6617 VAD-6673 VAD-6698 VAD-6794 VAD-7061 VAD-7157 VAD-7490 VAD-7843 VAD-7975 VAD-8015 VAD-8154 VAD-8273 VAD-8490 VAD-8517 VAD-8591 VAD-9069 VAD-9082 VAD-9107 VAD-9187 VAD-9235 VAD-9370 VAD-9395 VAD-9474 VAD-9671 VAD-9738 VAD-9786 VAD-9829 VAD-9850 VAD-9925 VAD-9937 O.U.S. VAD-10474 VAD-10953 VAD-11081 VAD-11251 VAD-12042 VAD-12648 VAD-12912 VAD-13618 VAD-13785 VAD-13954 VAD-14379 VAD-14529 VAD-14645 VAD-14708 VAD-14950 VAD-16560 VAD-16630 VAD-1690 VAD-1795 VAD-18277 VAD-18895 VAD-19291 VAD-19302 VAD-19316 VAD-19319 VAD-19387 VAD-19449 VAD-19450 VAD-19579 VAD-19674 VAD-19677 VAD-19699 VAD-19709 VAD-19714 VAD-19725 VAD-2313 VAD-3606 VAD-50265 VAD-50418 VAD-50924 VAD-51184 VAD-51275 VAD-51288 VAD-51327 VAD-51515 VAD-51516 VAD-52214 VAD-52260 VAD-52264 VAD-52444 VAD-52501 VAD-52508 VAD-52908 VAD-53018 VAD-53025 VAD-53468 VAD-53542 VAD-53627 VAD-53924 VAD-54047 VAD-54162 VAD-54241 VAD-54887 VAD-55069 VAD-55079 VAD-55225 VAD-55236 VAD-55251 VAD-55289 VAD-56707 VAD-57317 VAD-57496 VAD-57627 VAD-57629 VAD-58245 VAD-58424 VAD-58834 VAD-58851 VAD-58873 VAD-59808 VAD-60048 VAD-60354 VAD-60477 VAD-60540 VAD-61036 VAD-61047 VAD-61254 VAD-61585 VAD-62011 VAD-62068 VAD-62267 VAD-62283 VAD-62290 VAD-62297 VAD-62301 VAD-62303 VAD-62326 VAD-62337 VAD-62345 VAD-62347 VAD-62349 VAD-62353 VAD-62355 VAD-62362 VAD-62375 VAD-62380 VAD-62381 VAD-62385 VAD-62386 VAD-62388 VAD-62389 VAD-62391 VAD-62392 VAD-62393 VAD-62425 VAD-62428 VAD-62433 VAD-62434 VAD-62437 VAD-62438 VAD-62439 VAD-62455 VAD-62457 VAD-62460 VAD-62462 VAD-62463 VAD-62465 VAD-62466 VAD-62468 VAD-62469 VAD-62485 VAD-62487 VAD-62490 VAD-62491 VAD-62494 VAD-62495 VAD-62517 VAD-62520 VAD-62523 VAD-62527 VAD-62529 VAD-62548 VAD-62554 VAD-62555 VAD-62602 VAD-62603 VAD-62609 VAD-6387 VAD-6516 VAD-6955 VAD-7443 VAD-7725 VAD-7786 VAD-8689 VAD-9130 VAD-9330 VAD-9846 VAD-9940
• Recalling Firm/ Manufacturer: Thoratec Corp.; 6035 Stoneridge Dr; Pleasanton CA 94588-3270
• For Additional Information Contact: Abbott Technical Support; 800-456-1477
• Manufacturer Reason for Recall: Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
• FDA Determined Cause: Material/Component Contamination
• Action: On 02/19/2024, the firm will hand deliver an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers that informs them of Abbott's planned update to Instructions for Use associated with observations of outflow graft deformation known as "Extrinsic Outflow Graft Obstruction" (EOGO) associated with the HeartMate 3 and HeartMate II Left Ventricular Assist Systems (LVAS) which may manifest clinically as a persistent low flow alarm under certain circumstances in some patients and may impair the ability of the LVAS to provide adequate hemodynamic support. Guidance and Recommendations: Continue to pay attention to low flow alarms, the first symptom of significant outflow obstruction. -The following information provides guidance on how to diagnose unresolved low flow associated with outflow graft obstruction and recommended actions. A clinical article published in 2018 (Mehra et al. J Heart Lung Transplant. 2018 Nov;37(11):1281-1284.) includes a suggested diagnostic algorithm to recognize outflow graft obstruction for HeartMate 3 LVAD in the context of outflow graft twist. This published approach is appropriate to determine if significant EOGO is present and contributing to observed low flow alarms that are not able to be resolved." If the patient presents with symptoms such as a trend to reduced flow with no improvement back to baseline or persistent low flow alarms (with or without symptoms), the first step is to rule out other clinical conditions that could cause low flow. " If the patient signs or symptoms persist, it is important to rule out compression of the outflow graft through imaging such as a CT Angiogram. Abbott will update the Instructions for Use to include additional diagnostic recommendations and is in the process of developing and qualifying a design solution. for questions, contact Abbott Technical Support at 1-800-456-1477.
• Quantity in Commerce: 2,240 kits
• Distribution: Worldwide distribution: U.S.(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, VT, WA, WI, and WV; and O.U.S.(foreign) to countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Island, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Liechtenstein, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and South Korea.
• 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