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

Recall details

Manufacturer

Thoratec Corp.

Distributor

Worldwide 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.

Lot

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-0

Risk classification

Class I

Area (FDA)

device

Country

United States