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.

Recall details

Manufacturer

Thoratec Corp.

Distributor

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.

Lot

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

Risk classification

Class I

Area (FDA)

device

Country

United States