Class 2 Device Recall A810 CP app

• Date Initiated by Firm: November 21, 2024
• Date Posted: December 27, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0774-2025
• Recall Event ID: 95845
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• Product: SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
• Code Information: GTIN: 00763000447090 00763000729141 00763000737290 00763000447090; Serial Numbers: NPL3020725 NPL3021958 NPL3021963 NPL3021966 NPL3021969 NPL3021970 NPL3021971 NPL3021974 NPL3021983 NPL3021984 NPL3021990 NPL3021997 NPL3022002 NPL3022005 NPL3022014 NPL3022022 NPL3022031 NPL3022032 NPL3022038 NPL3022044 NPL3022052 NPL3022062 NPL3022069 NPL3022070 NPL3022071 NPL3022072 NPL3022073 NPL3022074 NPL3022109 NPL3022114 NPL3022118 NPL3022124 NPL3022125 NPL3022131 NPL3022139 NPL3022187 NPL3022190 NPL3022193 NPL3022194 NPL3022195 NPL3022212 NPL3022213 NPL3022216 NPL3022218 NPL3022245 NPL3022257 NPL3022278 NPL3022280 NPL3022289 NPL3022291 NPL3022304 NPL3022311 NPL3022313 NPL3022314 NPL3022328 NPL3022352 NPL3022357 NPL3022364 NPL3022365 NPL3022711 NPL3022713 NPL3022714 NPL3022715 NPL3022717 NPL3022735 NPL3022761 NPL3022762 NPL3022765 NPL3022767 NPL3022768 NPL3022769 NPL3022776 NPL3022791 NPL3022793 NPL3022795 NPL3022810 NPL3022811 NPL3022815 NPL3022817 NPL3022818 NPL3022831 NPL3022836 NPL3022838 NPL3022841 NPL3022844 NPL3022856 NPL3022858 NPL3022869 NPL3022870 NPL3022873 NPL3022874 NPL3022876 NPL3022877 NPL3022879 NPL3022893 NPL3022899 NPL3022900 NPL3022912 NPL3022918 NPL3022922 NPL3022926 NPL3022939 NPL3022940 NPL3022942 NPL3022954 NPL3022957 NPL3022958 NPL3022959 NPL3022968 NPL3022969 NPL3022973 NPL3022974 NPL3022981 NPL3022999 NPL3023030 NPL3023032 NPL3023035 NPL3023038 NPL3023042 NPL3023043 NPL3023048 NPL3023050 NPL3023054 NPL3023059 NPL3023061 NPL3023065 NPL3023067 NPL3023076 NPL3023078 NPL3023086 NPL3023093 NPL3023097 NPL3023123 NPL3023131 NPL3023132 NPL3023133 NPL3023136 NPL3023146 NPL3023148 NPL3023149 NPL3023150 NPL3023153 NPL3023156 NPL3023167 NPL3023175 NPL3023180 NPL3023192 NPL3023194 NPL3023197 NPL3023205 NPL3023218 NPL3023229 NPL3023237 NPL3023239 NPL3023241 NPL3023242 NPL3023245 NPL3023254 NPL3023256 NPL3023257 NPL3023260 NPL3023262 NPL3023268 NPL3023272 NPL3023278 NPL3023288 NPL3023292 NPL3023315 NPL3023317 NPL3023319 NPL3023322 NPL3023323 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NPL3031180 NPL3031183 NPL3031187 NPL3031188 NPL3031190 NPL3031191 NPL3031193 NPL3031194 NPL3031197 NPL3031198 NPL3031200 NPL3031201 NPL3031209 NPL3031212 NPL3031215 NPL3031220 NPL3031222 NPL3031225 NPL3031227 NPL3031228 NPL3031231 NPL3031232 NPL3031233 NPL3031239 NPL3031240 NPL3031241 NPL3031242 NPL3031244 NPL3031245 NPL3031247 NPL3031248 NPL3031250 NPL3031251 NPL3031252 NPL3031257 NPL3031258 NPL3031259 NPL3031261 NPL3031265 NPL3031266 NPL3031267 NPL3031273 NPL3031277 NPL3031278 NPL3031279 NPL3031281 NPL3031282 NPL3031283 NPL3031284 NPL3031290 NPL3031292 NPL3031294 NPL3031296 NPL3031300 NPL3031305 NPL3031306 NPL3031307 NPL3031308 NPL3031309 NPL3031310 NPL3031311 NPL3031312 NPL3031313 NPL3031314 NPL3031315 NPL3031317 NPL3031320 NPL3031321 NPL3031323 NPL3031331 NPL3031334 NPL3031336 NPL3031339 NPL3031349 NPL3031352 NPL3031354 NPL3031357 NPL3031358 NPL3031359 NPL3031361 NPL3031362 NPL3031363 NPL3031366 NPL3031367 NPL3031368 NPL3031369 NPL3031371 NPL3031373 NPL3031374 NPL3031375 NPL3031377 NPL3031378 NPL3031379 NPL3031380 NPL3031383 NPL3031387 NPL3031388 NPL3031393 NPL3031395 NPL3031396 NPL3031397 NPL3031402 NPL3031403 NPL3031404 NPL3031405 NPL3031407 NPL3031408 NPL3031413 NPL3031416 NPL3031419 NPL3031420 NPL3031421 NPL3031423 NPL3031428 NPL3031429 NPL3031430 NPL3031431 NPL3031432 NPL3031433 NPL3031437 NPL3031444 NPL3031447 NPL3031448 NPL3031451 NPL3031452 NPL3031453 NPL3031456 NPL3031459 NPL3031461 NPL3031463 NPL3031466 NPL3031467 NPL3031471 NPL3031472 NPL3031473 NPL3031475 NPL3031477 NPL3031478 NPL3031482 NPL3031483 NPL3031487 NPL3031488 NPL3031491 NPL3031495 NPL3031496 NPL3031500 NPL3031501 NPL3031504 NPL3031508 NPL3031509 NPL3031511 NPL3031514 NPL3031515 NPL3031518 NPL3031521 NPL3031522 NPL3031525 NPL3031529 NPL3031531 NPL3031534 NPL3031537 NPL3031538 NPL3031540 NPL3031544 NPL3031546 NPL3031547 NPL3031548 NPL3031550 NPL3031551 NPL3031555 NPL3031558 NPL3031562 NPL3031563 NPL3031566 NPL3031569 NPL3031570 NPL3031575 NPL3031577 NPL3031582 NPL3031585 NPL3031587 NPL3031591 NPL3031592 NPL3031593 NPL3031594 NPL3031595 NPL3031596 NPL3031597 NPL3031600 NPL3031602 NPL3031603 NPL3031604 NPL3031606 NPL3031608 NPL3031609 NPL3031612 NPL3031614 NPL3031620 NPL3031624 NPL3031627 NPL3031632 NPL3031635 NPL3031638 NPL3031640 NPL3031641 NPL3031644 NPL3031646 NPL3031648 NPL3031649 NPL3031650 NPL3031651 NPL3031653 NPL3031654 NPL3031657 NPL3031658 NPL3031659 NPL3031661 NPL3031665 NPL3031670 NPL3031671 NPL3031672 NPL3031674 NPL3031676 NPL3031679 NPL3031680 NPL3031687 NPL3031690 NPL3031693 NPL3031694 NPL3031695 NPL3031696 NPL3031698 NPL3031700 NPL3031701 NPL3031702 NPL3031705 NPL3031708 NPL3031709 NPL3031710 NPL3031713 NPL3031718 NPL3031725 NPL3031727 NPL3031735 NPL3031737 NPL3031740 NPL3031742 NPL3031743 NPL3031744 NPL3031746 NPL3031750 NPL3031758 NPL3031759 NPL3031760 NPL3031765 NPL3031767 NPL3031773 NPL3031775 NPL3031777 NPL3031782 NPL3031786 NPL3031790 NPL3031792 NPL3031795 NPL3031796 NPL3031805 NPL3031807 NPL3031809 NPL3031815 NPL3031816 NPL3031817 NPL3031819 NPL3031823 NPL3031824 NPL3031826 NPL3031830 NPL3031832 NPL3031840 NPL3031848 NPL3031849 NPL3031852 NPL3031859 NPL3031863 NPL3031864 NPL3031865 NPL3031868 NPL3031870 NPL3031872 NPL3031873 NPL3031877 NPL3031880 NPL3031881 NPL3031883 NPL3031884 NPL3031895 NPL3031900 NPL3031902 NPL3031905 NPL3031907 NPL3031911 NPL3031912 NPL3031913 NPL3031914 NPL3031920 NPL3031923 NPL3031927 NPL3031930 NPL3031931 NPL3031932 NPL3031938 NPL3031947 NPL3031950 NPL3031951 NPL3031952 NPL3031953 NPL3031954 NPL3031957 NPL3031964 NPL3031968 NPL3031971 NPL3031975 NPL3031979 NPL3031986 NPL3031987 NPL3031988 NPL3031993 NPL3031994 NPL3031995 NPL3032001 NPL3032005 NPL3032007 NPL3032009 NPL3032015 NPL3032017 NPL3032018 NPL3032019 NPL3032021 NPL3032023 NPL3032024 NPL3032025 NPL3032028 NPL3032031 NPL3032033 NPL3032035 NPL3032036 NPL3032037 NPL3032038 NPL3032041 NPL3032046 NPL3032049 NPL3032051 NPL3032054 NPL3032056 NPL3032058 NPL3032061 NPL3032062 NPL3032067 NPL3032068 NPL3032069 NPL3032072 NPL3032074 NPL3032076 NPL3032077 NPL3032078 NPL3032079 NPL3032081 NPL3032085 NPL3032087 NPL3032088 NPL3032089 NPL3032094 NPL3032095 NPL3032104 NPL3032106 NPL3032107 NPL3032109 NPL3032110 NPL3032111 NPL3032112 NPL3032117 NPL3032118 NPL3032120 NPL3032122 NPL3032123 NPL3032124 NPL3032135 NPL3032136 NPL3032143 NPL3032144 NPL3032145 NPL3032146 NPL3032150 NPL3032151 NPL3032153 NPL3032154 NPL3032163 NPL3032165 NPL3032167 NPL3032168 NPL3032173 NPL3032180 NPL3032183 NPL3032187 NPL3032190 NPL3032192 NPL3032193 NPL3032195 NPL3032200 NPL3032201 NPL3032202 NPL3032206 NPL3032207 NPL3032210 NPL3032212 NPL3032214 NPL3032215 NPL3032217 NPL3032218 NPL3032219 NPL3032223 NPL3032227 NPL3032229 NPL3032231 NPL3032232 NPL3032236 NPL3032237 NPL3032238 NPL3032239 NPL3032241 NPL3032243 NPL3032244 NPL3032246 NPL3032250 NPL3032251 NPL3032256 NPL3032261 NPL3032262 NPL3032263 NPL3032266 NPL3032268 NPL3032273 NPL3032277 NPL3032281 NPL3032283 NPL3032286 NPL3032291 NPL3032296 NPL3032308 NPL3032310 NPL3032311 NPL3032320 NPL3032328 NPL3032330 NPL3032344 NPL3032346 NPL3032347 NPL3032348 NPL3032356 NPL3032360 NPL3032361 NPL3032366 NPL3032373 NPL3032375 NPL3032377 NPL3032378 NPL3032380 NPL3032382 NPL3032383 NPL3032384 NPL3032385 NPL3032387 NPL3032390 NPL3032399 NPL3032401 NPL3032403 NPL3032407 NPL3032408 NPL3032410 NPL3032416 NPL3032418 NPL3032420 NPL3032421 NPL3032424 NPL3032426 NPL3032428 NPL3032435 NPL3032436 NPL3032437 NPL3032440 NPL3032441 NPL3032442 NPL3032450 NPL3032451 NPL3032453 NPL3032454 NPL3032455 NPL3032456 NPL3032457 NPL3032458 NPL3032462 NPL3032463 NPL3032465 NPL3032467 NPL3032470 NPL3032471 NPL3032474 NPL3032482 NPL3032483 NPL3032485 NPL3032486 NPL3032488 NPL3032489 NPL3032491 NPL3032492 NPL3032493 NPL3032495 NPL3032496 NPL3032497 NPL3032500 NPL3032501 NPL3032505 NPL3032507 NPL3032510 NPL3032512 NPL3032516 NPL3032522 NPL3032523 NPL3032530 NPL3032531 NPL3032532 NPL3032536 NPL3032547 NPL3032548 NPL3032549 NPL3032550 NPL3032551 NPL3032556 NPL3032557 NPL3032560 NPL3032562 NPL3032566 NPL3032568 NPL3032572 NPL3032573 NPL3032574 NPL3032577 NPL3032579 NPL3032583 NPL3032587 NPL3032588 NPL3032591 NPL3032592 NPL3032594 NPL3032595 NPL3032597 NPL3032598 NPL3032599 NPL3032601 NPL3032602 NPL3032603 NPL3032609 NPL3032610 NPL3032611 NPL3032612 NPL3032613 NPL3032614 NPL3032616 NPL3032620 NPL3032621 NPL3032622 NPL3032623 NPL3032624 NPL3032626 NPL3032627 NPL3032628 NPL3032629 NPL3032630 NPL3032632 NPL3032633 NPL3032640 NPL3032641 NPL3032642 NPL3032648 NPL3032650 NPL3032651 NPL3032652 NPL3032656 NPL3032660 NPL3032664 NPL3032665 NPL3032666 NPL3032668 NPL3032672 NPL3032681 NPL3032683 NPL3032687 NPL3032688 NPL3032689 NPL3032690 NPL3032692 NPL3032693 NPL3032696 NPL3032697 NPL3032701 NPL3032702 NPL3032703 NPL3032706 NPL3032709 NPL3032714 NPL3032715 NPL3032717 NPL3032718 NPL3032719 NPL3032722 NPL3032724 NPL3032727 NPL3032728 NPL3032729 NPL3032735 NPL3032736 NPL3032739 NPL3032740 NPL3032741 NPL3032742 NPL3032745 NPL3032746 NPL3032747 NPL3032748 NPL3032750 NPL3032756 NPL3032759 NPL3032761 NPL3032762 NPL3032763 NPL3032764 NPL3032770 NPL3032772 NPL3032773 NPL3032774 NPL3032776 NPL3032777 NPL3032778 NPL3032779 NPL3032781 NPL3032782 NPL3032783 NPL3032784 NPL3032790 NPL3032791 NPL3032797 NPL3032798 NPL3032799 NPL3032803 NPL3032806 NPL3032807 NPL3032810 NPL3032814 NPL3032816 NPL3032818 NPL3032819 NPL3032821 NPL3032823 NPL3032824 NPL3032826 NPL3032828 NPL3032833 NPL3032835 NPL3032837 NPL3032838 NPL3032839 NPL3032848 NPL3032850 NPL3032856 NPL3032858 NPL3032860 NPL3032862 NPL3032863 NPL3032867 NPL3032869 NPL3032871 NPL3032872 NPL3032876 NPL3032877 NPL3032878 NPL3032879 NPL3032880 NPL3032882 NPL3032883 NPL3032885 NPL3032888 NPL3032891 NPL3032892 NPL3032893 NPL3032895 NPL3032896 NPL3032900 NPL3032904 NPL3032906 NPL3032907 NPL3032909 NPL3032911 NPL3032915 NPL3032916 NPL3032918 NPL3032920 NPL3032921 NPL3032922 NPL3032926 NPL3032927 NPL3032929 NPL3032931 NPL3032932 NPL3032934 NPL3032938 NPL3032939 NPL3032942 NPL3032944 NPL3032945 NPL3032949 NPL3032952 NPL3032953 NPL3032954 NPL3032959 NPL3032965 NPL3032968 NPL3032970 NPL3032973 NPL3032975 NPL3032978 NPL3032980 NPL3032982 NPL3032983 NPL3032985 NPL3032986 NPL3032989 NPL3032991 NPL3032995 NPL3032996 NPL3032997 NPL3032998 NPL3033001 NPL3033003 NPL3033007 NPL3033008 NPL3033011 NPL3033015 NPL3033017 NPL3033019 NPL3033020 NPL3033022 NPL3033023 NPL3033025 NPL3033026 NPL3033027 NPL3033029 NPL3033030 NPL3033032 NPL3033035 NPL3033036 NPL3033037 NPL3033038 NPL3033039 NPL3033040 NPL3033042 NPL3033043 NPL3033046 NPL3033047 NPL3033048 NPL3033049 NPL3033051 NPL3033052 NPL3033054 NPL3033057 NPL3033059 NPL3033062 NPL3033064 NPL3033066 NPL3033067 NPL3033068 NPL3033069 NPL3033070 NPL3033071 NPL3033072 NPL3033073 NPL3033077 NPL3033079 NPL3033080 NPL3033081 NPL3033087 NPL3033088 NPL3033089 NPL3033094 NPL3033095 NPL3033096 NPL3033100 NPL3033102 NPL3033105 NPL3033106 NPL3033107 NPL3033109 NPL3033111 NPL3033113 NPL3033114 NPL3033115 NPL3033116 NPL3033122 NPL3033123 NPL3033124 NPL3033127 NPL3033130 NPL3033132 NPL3033133 NPL3033136 NPL3033137 NPL3033138 NPL3033139 NPL3033140 NPL3033142 NPL3033144 NPL3033145 NPL3033148 NPL3033150 NPL3033151 NPL3033155 NPL3033157 NPL3033158 NPL3033164 NPL3033165 NPL3033166 NPL3033167 NPL3033169 NPL3033172 NPL3033173 NPL3033174 NPL3033182 NPL3033185 NPL3033186 NPL3033187 NPL3033190 NPL3033191 NPL3033192 NPL3033194 NPL3033196 NPL3033199 NPL3033200 NPL3033201 NPL3033203 NPL3033205 NPL3033206 NPL3033207 NPL3033208 NPL3033210 NPL3033211 NPL3033216 NPL3033217 NPL3033219 NPL3033220 NPL3033221 NPL3033222 NPL3033225 NPL3033227 NPL3033228 NPL3033230 NPL3033233 NPL3033235 NPL3033237 NPL3033238 NPL3033239 NPL3033241 NPL3033242 NPL3033243 NPL3033244 NPL3033245 NPL3033247 NPL3033248 NPL3033249 NPL3033250 NPL3033253 NPL3033254 NPL3033256 NPL3033258 NPL3033259 NPL3033260 NPL3033262 NPL3033265 NPL3033266 NPL3033268 NPL3033270 NPL3033275 NPL3033278 NPL3033279 NPL3033282 NPL3033283 NPL3033284 NPL3033285 NPL3033286 NPL3033289 NPL3033290 NPL3033292 NPL3033293 NPL3033295 NPL3033298 NPL3033300 NPL3033302 NPL3033305 NPL3033306 NPL3033307 NPL3033308 NPL3033311 NPL3033318 NPL3033322 NPL3033323 NPL3033327 NPL3033330 NPL3033334 NPL3033338 NPL3033342 NPL3033345 NPL3033347 NPL3033348 NPL3033349 NPL3033351 NPL3033354 NPL3033357 NPL3033358 NPL3033362 NPL3033363 NPL3033364 NPL3033365 NPL3033368 NPL3033370 NPL3033371 NPL3033372 NPL3033373 NPL3033375 NPL3033376 NPL3033382 NPL3033383 NPL3033384 NPL3033386 NPL3033388 NPL3033390 NPL3033391 NPL3033396 NPL3033401 NPL3033407 NPL3033411 NPL3033415 NPL3033418 NPL3033426 NPL3033428 NPL3033429 NPL3033430 NPL3033432 NPL3033434 NPL3033439 NPL3033440 NPL3033442 NPL3033451 NPL3033463 NPL3033465 NPL3033467 NPL3033469 NPL3033471 NPL3033484 NPL3033488 NPL3033490 NPL3033492 NPL3033493 NPL3033498 NPL3033499 NPL3033500 NPL3033502 NPL3033504 NPL3033506 NPL3033508 NPL3033512 NPL3033513 NPL3033514 NPL3033519 NPL3033521 NPL3033523 NPL3033526 NPL3033528 NPL3033529 NPL3033530 NPL3033531 NPL3033532 NPL3033533 NPL3033535 NPL3033536 NPL3033537 NPL3033542 NPL3033547 NPL3033554 NPL3033557 NPL3033559 NPL3033560 NPL3033566 NPL3033567 NPL3033568 NPL3033573 NPL3033581 NPL3033583 NPL3033585 NPL3033588 NPL3033594 NPL3033598 NPL3033602 NPL3033604 NPL3033606 NPL3033609 NPL3033610 NPL3033611 NPL3033614 NPL3033616 NPL3033619 NPL3033620 NPL3033622 NPL3033623 NPL3033624 NPL3033625 NPL3033628 NPL3033629 NPL3033635 NPL3033638 NPL3033640 NPL3033641 NPL3033644 NPL3033645 NPL3033651 NPL3033653 NPL3033656 NPL3033659 NPL3033661 NPL3033663 NPL3033667 NPL3033673 NPL3033678 NPL3033680 NPL3033681 NPL3033685 NPL3033687 NPL3033696 NPL3033698 NPL3033699 NPL3033700 NPL3033706 NPL3033708 NPL3033716 NPL3033717 NPL3033718 NPL3033719 NPL3033721 NPL3033725 NPL3033726 NPL3033729 NPL3033731 NPL3033732 NPL3033733 NPL3033734 NPL3033735 NPL3033736 NPL3033739 NPL3033741 NPL3033742 NPL3033743 NPL3033746 NPL3033749 NPL3033750 NPL3033751 NPL3033753 NPL3033755 NPL3033756 NPL3033758 NPL3033760 NPL3033761 NPL3033762 NPL3033764 NPL3033765 NPL3033767 NPL3033768 NPL3033772 NPL3033775 NPL3033776 NPL3033777 NPL3033778 NPL3033779 NPL3033785 NPL3033786 NPL3033787 NPL3033790 NPL3033791 NPL3033796 NPL3033800 NPL3033802 NPL3033803 NPL3033805 NPL3033809 NPL3033811 NPL3033812 NPL3033813 NPL3033815 NPL3033816 NPL3033818 NPL3033822 NPL3033823 NPL3033824 NPL3033825 NPL3033828 NPL3033829 NPL3033830 NPL3033834 NPL3033836 NPL3033838 NPL3033839 NPL3033840 NPL3033841 NPL3033843 NPL3033844 NPL3033846 NPL3033849 NPL3033854 NPL3033857 NPL3033858 NPL3033859 NPL3033861 NPL3033862 NPL3033865 NPL3033868 NPL3033869 NPL3033872 NPL3033873 NPL3033874 NPL3033878 NPL3033879 NPL3033882 NPL3033883 NPL3033887 NPL3033888 NPL3033891 NPL3033893 NPL3033899 NPL3033900 NPL3033901 NPL3033902 NPL3033903 NPL3033908 NPL3033909 NPL3033911 NPL3033912 NPL3033913 NPL3033914 NPL3033916 NPL3033917 NPL3033918 NPL3033919 NPL3033922 NPL3033923 NPL3033925 NPL3033926 NPL3033927 NPL3033928 NPL3033930 NPL3033934 NPL3033935 NPL3033937 NPL3033940 NPL3033943 NPL3033944 NPL3033945 NPL3033948 NPL3033949 NPL3033954 NPL3033955 NPL3033956 NPL3033958 NPL3033959 NPL3033960 NPL3033962 NPL3033964 NPL3033966 NPL3033968 NPL3033975 NPL3033977 NPL3033978 NPL3033979 NPL3033980 NPL3033981 NPL3033983 NPL3033984 NPL3033987 NPL3033990 NPL3033991 NPL3033992 NPL3033993 NPL3033994 NPL3033995 NPL3033996 NPL3034000 NPL3034002 NPL3034004 NPL3034005 NPL3034007 NPL3034008 NPL3034009 NPL3034011 NPL3034013 NPL3034017 NPL3034018 NPL3034021 NPL3034022 NPL3034024 NPL3034026 NPL3034030 NPL3034032 NPL3034034 NPL3034035 NPL3034036 NPL3034039 NPL3034040 NPL3034042 NPL3034043 NPL3034044 NPL3034045 NPL3034046 NPL3034047 NPL3034048 NPL3034049 NPL3034050 NPL3034052 NPL3034054 NPL3034055 NPL3034056 NPL3034057 NPL3034058 NPL3034060 NPL3034062 NPL3034064 NPL3034065 NPL3034066 NPL3034067 NPL3034068 NPL3034072 NPL3034074 NPL3034075 NPL3034076 NPL3034078 NPL3034079 NPL3034080 NPL3034081 NPL3034083 NPL3034084 NPL3034085 NPL3034086 NPL3034088 NPL3034089 NPL3034090 NPL3034091 NPL3034092 NPL3034093 NPL3034095 NPL3034096 NPL3034097 NPL3034098 NPL3034100 NPL3034102 NPL3034103 NPL3034104 NPL3034105 NPL3034107 NPL3034108 NPL3034109 NPL3034111 NPL3034112 NPL3034115 NPL3034116 NPL3034119 NPL3034120 NPL3034121 NPL3034123 NPL3034124 NPL3034125 NPL3034126 NPL3034127 NPL3034128 NPL3034130 NPL3034131 NPL3034133 NPL3034134 NPL3034135 NPL3034137 NPL3034138 NPL3034141 NPL3034142 NPL3034143 NPL3034145 NPL3034148 NPL3034151 NPL3034152 NPL3034157 NPL3034158 NPL3034159 NPL3034161 NPL3034163 NPL3034165 NPL3034168 NPL3034169 NPL3034171 NPL3034172 NPL3034173 NPL3034178 NPL3034179 NPL3034181 NPL3034182 NPL3034183 NPL3034185 NPL3034186 NPL3034187 NPL3034188 NPL3034189 NPL3034192 NPL3034194 NPL3034198 NPL3034199 NPL3034200 NPL3034201 NPL3034203 NPL3034205 NPL3034206 NPL3034209 NPL3034210 NPL3034211 NPL3034215 NPL3034216 NPL3034226 NPL3034227 NPL3034229 NPL3034231 NPL3034232 NPL3034233 NPL3034234 NPL3034236 NPL3034237 NPL3034238 NPL3034239 NPL3034240 NPL3034243 NPL3034244 NPL3034247 NPL3034250 NPL3034252 NPL3034253 NPL3034256 NPL3034259 NPL3034260 NPL3034262 NPL3034264 NPL3034266 NPL3034267 NPL3034269 NPL3034270 NPL3034271 NPL3034275 NPL3034276 NPL3034277 NPL3034278 NPL3034279 NPL3034280 NPL3034285 NPL3034286 NPL3034290 NPL3034291 NPL3034292 NPL3034294 NPL3034295 NPL3034296 NPL3034299 NPL3034301 NPL3034303 NPL3034306 NPL3034307 NPL3034308 NPL3034310 NPL3034316 NPL3034317 NPL3034319 NPL3034323 NPL3034324 NPL3034325 NPL3034326 NPL3034330 NPL3034331 NPL3034332 NPL3034334 NPL3034335 NPL3034339 NPL3034341 NPL3034342 NPL3034343 NPL3034345 NPL3034347 NPL3034348 NPL3034351 NPL3034352 NPL3034353 NPL3034354 NPL3034355 NPL3034357 NPL3034359 NPL3034360 NPL3034361 NPL3034363 NPL3034366 NPL3034367 NPL3034368 NPL3034370 NPL3034371 NPL3034372 NPL3034373 NPL3034374 NPL3034378 NPL3034380 NPL3034381 NPL3034382 NPL3034383 NPL3034384 NPL3034385 NPL3034388 NPL3034390 NPL3034391 NPL3034392 NPL3034397 NPL3034400 NPL3034402 NPL3034404 NPL3034405 NPL3034406 NPL3034407 NPL3034418 NPL3034421 NPL3034425 NPL3034427 NPL3034431 NPL3034437 NPL3034440 NPL3034441 NPL3034444 NPL3034449 NPL3034450 NPL3034459 NPL3034460 NPL3034461 NPL3034464 NPL3034465 NPL3034466 NPL3034467 NPL3034468 NPL3034470 NPL3034472 NPL3034474 NPL3034475 NPL3034477 NPL3034478 NPL3034479 NPL3034480 NPL3034483 NPL3034484 NPL3034490 NPL3034492 NPL3034493 NPL3034494 NPL3034495 NPL3034496 NPL3034498 NPL3034500 NPL3034502 NPL3034505 NPL3034506 NPL3034507 NPL3034513 NPL3034519 NPL3034520 NPL3034529 NPL3034534 NPL3034536 NPL3034539 NPL3034543 NPL3034544 NPL3034547 NPL3034548 NPL3034549 NPL3034550 NPL3034552 NPL3034553 NPL3034555 NPL3034556 NPL3034557 NPL3034560 NPL3034563 NPL3034571 NPL3034572 NPL3034574 NPL3034575 NPL3034592 NPL3034595 NPL3034597 NPL3034605 NPL3034608 NPL3034610 NPL3034615 NPL3034616 NPL3034618 NPL3034619 NPL3034634 NPL3034635 NPL3034636 NPL3034638 NPL3034641 NPL3034644 NPL3034648 NPL3034649 NPL3034651 NPL3034652 NPL3034658 NPL3034659 NPL3034661 NPL3034662 NPL3034665 NPL3034669 NPL3034670 NPL3034671 NPL3034673 NPL3034674 NPL3034676 NPL3034678 NPL3034679 NPL3034680 NPL3034681 NPL3034683 NPL3034685 NPL3034686 NPL3034688 NPL3034692 NPL3034693 NPL3034697 NPL3034702 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• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave Ne; Minneapolis MN 55432-3568
• For Additional Information Contact: Naomi Rodiles; 763-514-2000
• Manufacturer Reason for Recall: Software issues were identified in application version 2.x.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT: MEDICAL DEVICE CORRECTION notification letter dated November 2024 was sent to customers. Actions Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records. Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. Additional Information Medtronic is actively working on a permanent solution and will inform you as soon as it becomes available. Medtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality problems experienced with this product should be reported to Medtronic and the FDA MedWatch Adverse Event Reporting program via: Medtronic email at RS.NeuAdverseEventReporting@Medtronic.com or Medtronic Technical Services at 1-800-707-0933 weekdays 7:00 AM 6:00 PM CT. ***Update January 2026*** An URGENT: MEDICAL DEVICE CORRECTION notification letter dated January 2026 was sent to customers. The purpose of this letter is to inform you that a new version of the Model A810 SynchroMed Clinician Programmer Application (CP App), v2.0.3320, is now available for installation. This update addresses previously communicated software issues associated with earlier versions used for the Model 8637 SynchroMed II and Model 8667 SynchroMed III infusion pumps. These issues were initially communicated to you in the letter enclosed from November 2024. The new version of the A810 CP App resolves these issues. Customer Actions: " Download and install A810 CP App v2.0.3320 at your earliest convenience and contact your local Medtronic representative if you have any questions related to the update. " Sign and return the Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. Retain a copy of this lette
• Quantity in Commerce: 3981 systems
• Distribution: Worldwide - US Nationwide distribution.
• 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.