HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigatio... — FDA record Z-1301-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 19, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
Reason
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Classification
Class I
Recalling firm
Thoratec Corp.
Quantity
22,663 kits
Agency-reported status
Ongoing
Source record identifier
Z-1301-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityHeartMate 3 LVAS Model Numbers: 1. 105581 (IDE, cannot be implanted without a Left Ventricular Assist Device (LVAD)) 2. 105581US (cannot be implanted without a LVAD) 3. 105581INT (cannot be implanted without a LVAD) 4. 106524 (IDE) 5. 106524US 6. 106524INT UDI-DI codes: HeartMate 3 LVAS: 1. N/A (IDE) 2. 00813024013266 3. 00813024011675 4. N/A (IDE) 5. 00813024013297 6. 00813024011712 Serial Numbers: For Model 106524 US MLP-000991 MLP-002058 MLP-002066 MLP-002069 MLP-002070 MLP-002076 MLP-002117 MLP-002126 MLP-002128 MLP-002133 MLP-002136 MLP-002152 MLP-002158 MLP-002159 MLP-002160 MLP-002164 MLP-002165 MLP-002191 MLP-002192 MLP-002197 MLP-002206 MLP-002208 MLP-002216 MLP-002217 MLP-002239 MLP-002241 MLP-002246 MLP-002251 MLP-002254 MLP-002259 MLP-002263 MLP-002268 MLP-002269 MLP-002278 MLP-002288 MLP-002289 MLP-002291 MLP-002294 MLP-002300 MLP-002304 MLP-002309 MLP-002310 MLP-002316 MLP-002318 MLP-002321 MLP-002324 MLP-002337 MLP-002342 MLP-002347 MLP-002355 MLP-002356 MLP-002361 MLP-002365 MLP-002450 MLP-002455 MLP-002456 MLP-002472 MLP-002475 MLP-002510 MLP-002514 MLP-002518 MLP-002519 MLP-002520 MLP-002530 MLP-002536 MLP-002538 MLP-002539 MLP-002543 MLP-002589 MLP-002597 MLP-002603 MLP-002633 MLP-002643 MLP-002646 MLP-002650 MLP-002654 MLP-002660 MLP-002663 MLP-002666 MLP-002805 MLP-002807 MLP-002808 MLP-002809 MLP-002827 MLP-002828 MLP-002838 MLP-002840 MLP-002842 MLP-002844 MLP-002850 MLP-002858 MLP-002957 MLP-003028 MLP-003033 MLP-003057 MLP-003058 MLP-003068 MLP-003070 MLP-003072 MLP-003074 MLP-003077 MLP-003085 MLP-003086 MLP-003089 MLP-003097 MLP-003110 MLP-003114 MLP-003125 MLP-003130 MLP-003131 MLP-003140 MLP-003148 MLP-003186 MLP-003237 MLP-003255 MLP-003257 MLP-003259 MLP-003277 MLP-003291 MLP-003299 MLP-003300 MLP-003302 MLP-003307 MLP-003308 MLP-003314 MLP-003317 MLP-003340 MLP-003347 MLP-003348 MLP-003351 MLP-003352 MLP-003384 MLP-003385 MLP-003388 MLP-003389 MLP-003390 MLP-003441 MLP-003442 MLP-003461 MLP-003466 MLP-003469 MLP-003471 MLP-003571 MLP-003572 MLP-003574 MLP-003577 MLP-003578 MLP-003582 MLP-003588 MLP-003615 MLP-003616 MLP-003617 MLP-003621 MLP-003629 MLP-003654 MLP-003659 MLP-003661 MLP-003689 MLP-003692 MLP-003738 MLP-003741 MLP-003828 MLP-003829 MLP-003858 MLP-003861 MLP-003862 MLP-003863 MLP-003867 MLP-004093 MLP-004110 MLP-004118 MLP-004119 MLP-004125 MLP-004129 MLP-004131 MLP-004137 MLP-004148 MLP-004151 MLP-004153 MLP-004156 MLP-004157 MLP-004165 MLP-004166 MLP-004171 MLP-004212 MLP-004242 MLP-004247 MLP-004267 MLP-004279 MLP-004281 MLP-004293 MLP-004298 MLP-004310 MLP-004384 MLP-004469 MLP-004486 MLP-004490 MLP-004525 MLP-004584 MLP-004591 MLP-004667 MLP-004675 MLP-004686 MLP-004697 MLP-004802 MLP-004805 MLP-004806 MLP-004866 MLP-004867 MLP-004869 MLP-004870 MLP-004874 MLP-004876 MLP-004877 MLP-004878 MLP-004884 MLP-004885 MLP-004887 MLP-004893 MLP-004954 MLP-004962 MLP-004963 MLP-004968 MLP-004969 MLP-004971 MLP-004983 MLP-004996 MLP-004998 MLP-005006 MLP-005032 MLP-005033 MLP-005036 MLP-005050 MLP-005052 MLP-005054 MLP-005083 MLP-005117 MLP-005122 MLP-005144 MLP-005145 MLP-005183 MLP-005186 MLP-005187 MLP-005193 MLP-005208 MLP-005212 MLP-005215 MLP-005219 MLP-005228 MLP-005258 MLP-005260 MLP-005261 MLP-005291 MLP-005292 MLP-005293 MLP-005298 MLP-005299 MLP-005320 MLP-005322 MLP-005323 MLP-005324 MLP-005328 MLP-005337 MLP-005391 MLP-005393 MLP-005396 MLP-005398 MLP-005402 MLP-005410 MLP-005411 MLP-005414 MLP-005416 MLP-005438 MLP-005440 MLP-005444 MLP-005460 MLP-005468 MLP-005483 MLP-005484 MLP-005485 MLP-005492 MLP-005494 MLP-005497 MLP-005498 MLP-005512 MLP-005531 MLP-005532 MLP-005539 MLP-005540 MLP-005541 MLP-005544 MLP-005552 MLP-005555 MLP-005559 MLP-005576 MLP-005594 MLP-005597 MLP-005600 MLP-005602 MLP-005613 MLP-005620 MLP-005636 MLP-005638 MLP-005641 MLP-005650 MLP-005653 MLP-005655 MLP-005663 MLP-005668 MLP-005680 MLP-005684 MLP-005703 MLP-005704 MLP-005706 MLP-005708 MLP-005729 MLP-005730 MLP-005746 MLP-005747 MLP-005752 MLP-005754 MLP-005769 MLP-005791 MLP-005793 MLP-005794 MLP-005795 MLP-005798 MLP-005812 MLP-005820 MLP-005821 MLP-005822 MLP-005825 MLP-005828 MLP-005831 MLP-005835 MLP-005836 MLP-005838 MLP-005853 MLP-005871 MLP-005879 MLP-005901 MLP-005902 MLP-005924 MLP-005934 MLP-005967 MLP-006005 MLP-006040 MLP-006041 MLP-006053 MLP-006067 MLP-006127 MLP-006128 MLP-006192 MLP-006193 MLP-006203 MLP-006204 MLP-006207 MLP-006216 MLP-006240 MLP-006245 MLP-006246 MLP-006249 MLP-006294 MLP-006303 MLP-006304 MLP-006390 MLP-006412 MLP-006413 MLP-006423 MLP-006431 MLP-006435 MLP-006437 MLP-006450 MLP-006452 MLP-006463 MLP-006470 MLP-006471 MLP-006477 MLP-006489 MLP-006490 MLP-006534 MLP-006535 MLP-006538 MLP-006539 MLP-006553 MLP-006571 MLP-006577 MLP-006578 MLP-006585 MLP-006587 MLP-006588 MLP-006595 MLP-006629 MLP-006631 MLP-006632 MLP-006633 MLP-006661 MLP-006663 MLP-006675 MLP-006677 MLP-006678 MLP-006688 MLP-006690 MLP-006710 MLP-006711 MLP-006715 MLP-006773 MLP-006801 MLP-006811 MLP-006827 MLP-006829 MLP-006831 MLP-006832 MLP-006846 MLP-006847 MLP-006848 MLP-006849 MLP-006851 MLP-006852 MLP-007250 MLP-007381 MLP-007388 MLP-007391 MLP-007396 MLP-007399 MLP-007400 MLP-007405 MLP-007408 MLP-007417 MLP-007420 MLP-007422 MLP-007428 MLP-007433 MLP-007444 MLP-007446 MLP-007447 MLP-007451 MLP-007459 MLP-007870 MLP-007871 MLP-007897 MLP-007905 MLP-007908 MLP-007921 MLP-007923 MLP-007926 MLP-007928 MLP-007929 MLP-007983 MLP-007985 MLP-007987 MLP-007988 MLP-007996 MLP-007997 MLP-007999 MLP-008005 MLP-008084 MLP-008085 MLP-008118 MLP-008119 MLP-008120 MLP-008161 MLP-008162 MLP-008165 MLP-008191 MLP-008194 MLP-008197 MLP-008199 MLP-008200 MLP-008250 MLP-008251 MLP-008252 MLP-008254 MLP-008255 MLP-008258 MLP-008266 MLP-008295 MLP-008296 MLP-008298 MLP-008302 MLP-008306 MLP-008308 MLP-008328 MLP-008329 MLP-008330 MLP-008385 MLP-008387 MLP-008388 MLP-008391 MLP-008392 MLP-008400 MLP-008401 MLP-008402 MLP-008403 MLP-008416 MLP-008417 MLP-008419 MLP-008425 MLP-008430 MLP-008445 MLP-008446 MLP-008524 MLP-008526 MLP-008528 MLP-008529 MLP-008550 MLP-008554 MLP-008556 MLP-008563 MLP-008565 MLP-008566 MLP-008576 MLP-008593 MLP-008606 MLP-008609 MLP-008651 MLP-008654 MLP-008656 MLP-008658 MLP-008659 MLP-008660 MLP-008661 MLP-008679 MLP-008681 MLP-008683 MLP-008809 MLP-008810 MLP-008811 MLP-008817 MLP-008819 MLP-008908 MLP-008911 MLP-008919 MLP-008928 MLP-008932 MLP-008933 MLP-008937 MLP-008939 MLP-009011 MLP-009012 MLP-009123 MLP-009124 MLP-009125 MLP-009126 MLP-009132 MLP-009153 MLP-009228 MLP-009259 MLP-009265 MLP-009273 MLP-009274 MLP-009275 MLP-009278 MLP-009280 MLP-009284 MLP-009285 MLP-009286 MLP-009287 MLP-009297 MLP-009308 MLP-009310 MLP-009311 MLP-009313 MLP-009315 MLP-009329 MLP-009330 MLP-009334 MLP-009335 MLP-009336 MLP-009341 MLP-009342 MLP-009357 MLP-009360 MLP-009364 MLP-009365 MLP-009368 MLP-009399 MLP-009413 MLP-009414 MLP-009416 MLP-009418 MLP-009423 MLP-009427 MLP-009429 MLP-009438 MLP-009442 MLP-009443 MLP-009448 MLP-009451 MLP-009453 MLP-009455 MLP-009456 MLP-009483 MLP-009491 MLP-009503 MLP-009504 MLP-009505 MLP-009506 MLP-009510 MLP-009521 MLP-009522 MLP-009528 MLP-009543 MLP-009647 MLP-009648 MLP-009649 MLP-009651 MLP-009652 MLP-009654 MLP-009655 MLP-009675 MLP-009677 MLP-009678 MLP-009681 MLP-009682 MLP-009695 MLP-009698 MLP-009699 MLP-009712 MLP-009732 MLP-009736 MLP-009741 MLP-009742 MLP-009751 MLP-009752 MLP-009753 MLP-009754 MLP-009755 MLP-009757 MLP-009758 MLP-009760 MLP-009765 MLP-009774 MLP-009778 MLP-009779 MLP-009783 MLP-009785 MLP-009790 MLP-009792 MLP-009796 MLP-009800 MLP-009803 MLP-009804 MLP-009810 MLP-009815 MLP-009816 MLP-009820 MLP-009822 MLP-009825 MLP-009826 MLP-009832 MLP-009837 MLP-009839 MLP-009865 MLP-009867 MLP-009868 MLP-009870 MLP-009872 MLP-009873 MLP-009910 MLP-009911 MLP-009915 MLP-009916 MLP-009921 MLP-009922 MLP-009925 MLP-009926 MLP-009927 MLP-009929 MLP-009980 MLP-009981 MLP-009995 MLP-009996 MLP-010001 MLP-010003 MLP-010006 MLP-010032 MLP-010034 MLP-010046 MLP-010047 MLP-010048 MLP-010065 MLP-010068 MLP-010105 MLP-010120 MLP-010121 MLP-010166 MLP-010167 MLP-010179 MLP-010180 MLP-010182 MLP-010183 MLP-010199 MLP-010276 MLP-010280 MLP-010288 MLP-010306 MLP-010317 MLP-010385 MLP-010386 MLP-010392 MLP-010406 MLP-010412 MLP-010424 MLP-010435 MLP-010437 MLP-010452 MLP-010453 MLP-010465 MLP-010473 MLP-010474 MLP-010485 MLP-010504 MLP-010573 MLP-010574 MLP-010577 MLP-010578 MLP-010609 MLP-010776 MLP-010847 MLP-010848 MLP-010849 MLP-010852 MLP-010853 MLP-010860 MLP-010861 MLP-010906 MLP-010924 MLP-010938 MLP-010939 MLP-010940 MLP-010941 MLP-010942 MLP-010945 MLP-010946 MLP-010952 MLP-010953 MLP-010955 MLP-010957 MLP-010970 MLP-011066 MLP-011070 MLP-011088 MLP-011117 MLP-011118 MLP-011120 MLP-011123 MLP-011124 MLP-011125 MLP-011131 MLP-011136 MLP-011137 MLP-011138 MLP-011140 MLP-011190 MLP-011191 MLP-011193 MLP-011336 MLP-011370 MLP-011371 MLP-011372 MLP-011542 MLP-011545 MLP-011547 MLP-011550 MLP-011552 MLP-011647 MLP-011654 MLP-011656 MLP-011657 MLP-011658 MLP-011660 MLP-011661 MLP-011701 MLP-011702 MLP-011704 MLP-012115 MLP-012117 MLP-012121 MLP-012123 MLP-012145 MLP-012160 MLP-012180 MLP-012182 MLP-012183 MLP-012184 MLP-012185 MLP-012189 MLP-012190 MLP-012191 MLP-012193 MLP-012199 MLP-012266 MLP-012267 MLP-012268 MLP-012303 MLP-012334 MLP-012338 MLP-012349 MLP-012377 MLP-012405 MLP-012407 MLP-012408 MLP-012410 MLP-012420 MLP-012421 MLP-012612 MLP-012618 MLP-012619 MLP-012629 MLP-012631 MLP-012633 MLP-012636 MLP-012667 MLP-012745 OUS MLP-002000 MLP-002003 MLP-002005 MLP-002015 MLP-002019 MLP-002022 MLP-002023 MLP-002024 MLP-002026 MLP-002027 MLP-002028 MLP-002043 MLP-002050 MLP-002053 MLP-002055 MLP-002064 MLP-002095 MLP-002097 MLP-002098 MLP-002101 MLP-002103 MLP-002105 MLP-002106 MLP-002111 MLP-002113 MLP-002114 MLP-002115 MLP-002116 MLP-002122 MLP-002143 MLP-002145 MLP-002147 MLP-002150 MLP-002153 MLP-002186 MLP-002190 MLP-002194 MLP-002230 MLP-002322 MLP-002323 MLP-002328 MLP-006360 MLP-006364 MLP-007409 MLP-007873 MLP-007917 MLP-007918 MLP-008122 MLP-008123 MLP-009290 MLP-009372 MLP-009420 For Model 106524US US MLP-006853 MLP-006869 MLP-007411 MLP-007412 MLP-007445 MLP-007465 MLP-007468 MLP-007474 MLP-007475 MLP-007504 MLP-007508 MLP-007510 MLP-007538 MLP-007584 MLP-007585 MLP-007590 MLP-007604 MLP-007611 MLP-007625 MLP-007628 MLP-007630 MLP-007631 MLP-007635 MLP-007637 MLP-007642 MLP-007643 MLP-007657 MLP-007658 MLP-007660 MLP-007662 MLP-007670 MLP-007672 MLP-007678 MLP-007679 MLP-007682 MLP-007685 MLP-007686 MLP-007687 MLP-007690 MLP-007702 MLP-007705 MLP-007711 MLP-007716 MLP-007717 MLP-007719 MLP-007765 MLP-007766 MLP-007767 MLP-007768 MLP-007773 MLP-007774 MLP-007775 MLP-007777 MLP-007780 MLP-007792 MLP-007801 MLP-007802 MLP-007803 MLP-007823 MLP-007826 MLP-007835 MLP-007837 MLP-007874 MLP-007876 MLP-007880 MLP-007883 MLP-007888 MLP-007889 MLP-007909 MLP-007912 MLP-007913 MLP-007915 MLP-007916 MLP-007936 MLP-007938 MLP-007943 MLP-008023 MLP-008024 MLP-008028 MLP-008046 MLP-008049 MLP-008052 MLP-008054 MLP-008068 MLP-008069 MLP-008079 MLP-008080 MLP-008081 MLP-008082 MLP-008089 MLP-008104 MLP-008110 MLP-008111 MLP-008113 MLP-008116 MLP-008117 MLP-008121 MLP-008129 MLP-008130 MLP-008131 MLP-008138 MLP-008140 MLP-008164 MLP-008167 MLP-008168 MLP-008201 MLP-008204 MLP-008205 MLP-008208 MLP-008210 MLP-008217 MLP-008220 MLP-008222 MLP-008247 MLP-008270 MLP-008277 MLP-008284 MLP-008303 MLP-008312 MLP-008314 MLP-008346 MLP-008350 MLP-008351 MLP-008353 MLP-008359 MLP-008363 MLP-008366 MLP-008380 MLP-008381 MLP-008426 MLP-008429 MLP-008442 MLP-008464 MLP-008469 MLP-008503 MLP-008506 MLP-008507 MLP-008510 MLP-008516 MLP-008517 MLP-008521 MLP-008535 MLP-008541 MLP-008542 MLP-008548 MLP-008552 MLP-008557 MLP-008559 MLP-008578 MLP-008582 MLP-008586 MLP-008588 MLP-008611 MLP-008615 MLP-008618 MLP-008619 MLP-008621 MLP-008623 MLP-008647 MLP-008650 MLP-008766 MLP-008773 MLP-008796 MLP-008799 MLP-008813 MLP-008815 MLP-008824 MLP-008827 MLP-008831 MLP-008832 MLP-008839 MLP-008842 MLP-008843 MLP-008846 MLP-008847 MLP-008879 MLP-008882 MLP-008885 MLP-008886 MLP-008888 MLP-008890 MLP-008898 MLP-00890...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Mar 27, 2024
Recall initiation date
Feb 19, 2024
Center classification date
Mar 21, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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