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U.S. Department of Health and Human Services

Class 2 Device Recall Stimulation RC Clinician Programmer Application

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 Class 2 Device Recall Stimulation RC Clinician Programmer Applicationsee related information
Date Initiated by FirmMarch 04, 2025
Date PostedApril 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1543-2025
Recall Event ID 96445
PMA NumberP840001S512 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
ProductStimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Code Information UDI-DI: 00763000371463; Serial Numbers: NPL1000037 NPL1000042 NPL1000053 NPL1000055 NPL1000056 NPL1000062 NPL1000067 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000076 NPL1000098 NPL1000135 NPL1000137 NPL1000138 NPL1000151 NPL1000160 NPL1000161 NPL1000165 NPL1000173 NPL1000174 NPL1000175 NPL1000179 NPL1000180 NPL1000185 NPL1000186 NPL1000188 NPL1000189 NPL1000191 NPL1000195 NPL1000230 NPL1000238 NPL1000242 NPL1000244 NPL1000245 NPL1000246 NPL1000248 NPL1000249 NPL1000252 NPL1000281 NPL1000292 NPL1000295 NPL1000297 NPL1000301 NPL1000303 NPL1000304 NPL1000305 NPL1000323 NPL1000325 NPL1000331 NPL1000344 NPL1000361 NPL1000363 NPL1000364 NPL1000365 NPL1000370 NPL1000429 NPL1000435 NPL1000443 NPL1000446 NPL1000447 NPL1000453 NPL1000486 NPL1000502 NPL1000504 NPL1000505 NPL1000506 NPL1000507 NPL1000509 NPL1000510 NPL1000514 NPL1000516 NPL1000518 NPL1000519 NPL1000528 NPL1000533 NPL1000555 NPL1000558 NPL1000561 NPL1000562 NPL1000575 NPL1000584 NPL1000585 NPL1000592 NPL1000603 NPL1000606 NPL1000612 NPL1000631 NPL1000634 NPL1000638 NPL1000639 NPL1000652 NPL1000653 NPL1000657 NPL1000776 NPL1000794 NPL1000814 NPL1000815 NPL1000817 NPL1000819 NPL1000834 NPL1000835 NPL1001212 NPL1001236 NPL1001241 NPL1001245 NPL1001246 NPL1001265 NPL1001273 NPL1001282 NPL1001301 NPL1001332 NPL1001339 NPL1001353 NPL1001354 NPL1001364 NPL1001369 NPL1001371 NPL1001389 NPL1001429 NPL1001434 NPL1001435 NPL1001436 NPL1001449 NPL1001464 NPL1001506 NPL1001507 NPL1001512 NPL1001520 NPL1001542 NPL1001549 NPL1001558 NPL1001588 NPL1001591 NPL1001592 NPL1001608 NPL1001647 NPL1001650 NPL1001670 NPL1001678 NPL1001694 NPL1001695 NPL1001697 NPL1001700 NPL1001702 NPL1001705 NPL1001707 NPL1001708 NPL1001709 NPL1001710 NPL1001711 NPL1001716 NPL1001717 NPL1001727 NPL1001728 NPL1001756 NPL1001759 NPL1001763 NPL1001764 NPL1001765 NPL1001769 NPL1001773 NPL1001789 NPL1001797 NPL1001798 NPL1001800 NPL1001801 NPL1001804 NPL1001811 NPL1001812 NPL1001815 NPL1001816 NPL1001817 NPL1001823 NPL1001824 NPL1001825 NPL1001841 NPL1001847 NPL1001881 NPL1001882 NPL1001884 NPL1001889 NPL1001896 NPL1001933 NPL1001947 NPL1001963 NPL1002004 NPL1002007 NPL1002018 NPL1002064 NPL1002088 NPL1002089 NPL1002091 NPL1002092 NPL1002200 NPL1002214 NPL1002226 NPL1002227 NPL1002232 NPL1002250 NPL1002284 NPL1002288 NPL1002295 NPL1002307 NPL1002309 NPL1002310 NPL1002327 NPL1002330 NPL1002340 NPL1002341 NPL1002347 NPL1002362 NPL1002363 NPL1002369 NPL1002380 NPL1002382 NPL1002410 NPL1002428 NPL1002433 NPL1002438 NPL1002440 NPL1002443 NPL1002445 NPL1002467 NPL1002470 NPL1002503 NPL1002505 NPL1002508 NPL1002540 NPL1002544 NPL1002545 NPL1002548 NPL1002555 NPL1002556 NPL1002568 NPL1002572 NPL1002592 NPL1002618 NPL1002637 NPL1002639 NPL1002640 NPL1002648 NPL1002649 NPL1002656 NPL1002665 NPL1002666 NPL1002672 NPL1002673 NPL1002674 NPL1002690 NPL1002707 NPL1002730 NPL1002756 NPL1002760 NPL1002780 NPL3000005 NPL3000006 NPL3000007 NPL3000009 NPL3000010 NPL3000011 NPL3000016 NPL3000017 NPL3000018 NPL3000023 NPL3000024 NPL3000025 NPL3000026 NPL3000030 NPL3000031 NPL3000035 NPL3000038 NPL3000042 NPL3000043 NPL3000048 NPL3000050 NPL3000055 NPL3000056 NPL3000058 NPL3000059 NPL3000066 NPL3000070 NPL3000075 NPL3000083 NPL3000090 NPL3000094 NPL3000097 NPL3000098 NPL3000109 NPL3000110 NPL3000120 NPL3000125 NPL3000129 NPL3000134 NPL3000135 NPL3000183 NPL3000185 NPL3000186 NPL3000187 NPL3000188 NPL3000191 NPL3000192 NPL3000203 NPL3000208 NPL3000209 NPL3000212 NPL3000215 NPL3000217 NPL3000220 NPL3000221 NPL3000222 NPL3000223 NPL3000231 NPL3000241 NPL3000252 NPL3000253 NPL3000254 NPL3002258 NPL3002260 NPL3002264 NPL3002270 NPL3002272 NPL3002273 NPL3002275 NPL3002278 NPL3002279 NPL3002282 NPL3002283 NPL3002290 NPL3002293 NPL3002297 NPL3002301 NPL3002306 NPL3002307 NPL3002655 NPL3002657 NPL3002660 NPL3002682 NPL3002683 NPL3002710 NPL3002726 NPL3002735 NPL3002744 NPL3002873 NPL3002875 NPL3002877 NPL3002891 NPL3002895 NPL3002897 NPL3002899 NPL3002908 NPL3002910 NPL3002911 NPL3002912 NPL3002919 NPL3002922 NPL3002923 NPL3002925 NPL3002927 NPL3002928 NPL3002932 NPL3002937 NPL3002945 NPL3002954 NPL3002960 NPL3003300 NPL3003307 NPL3003315 NPL3003320 NPL3003338 NPL3003339 NPL3003344 NPL3003353 NPL3003357 NPL3003358 NPL3003549 NPL3003551 NPL3003553 NPL3003557 NPL3003569 NPL3003570 NPL3003700 NPL3003710 NPL3003716 NPL3003717 NPL3003726 NPL3003735 NPL3003741 NPL3003742 NPL3003987 NPL3005006 NPL3005009 NPL3005025 NPL3005843 NPL3006029 NPL3006068 NPL3006072 NPL3006084 NPL3006132 NPL3006238 NPL3006310 NPL3006357 NPL3006367 NPL3006374 NPL3006375 NPL3006377 NPL3006407 NPL3006414 NPL3006452 NPL3006458 NPL3006465 NPL3006469 NPL3006470 NPL3006476 NPL3006482 NPL3006483 NPL3006484 NPL3006485 NPL3006489 NPL3006490 NPL3006494 NPL3006495 NPL3006498 NPL3006518 NPL3006519 NPL3006522 NPL3006525 NPL3006536 NPL3006634 NPL3006911 NPL3006934 NPL3006944 NPL3006951 NPL3006953 NPL3006966 NPL3006967 NPL3006983 NPL3007387 NPL3007392 NPL3007591 NPL3007877 NPL3007892 NPL3007895 NPL3007896 NPL3007897 NPL3007908 NPL3007921 NPL3010632 NPL3010654 NPL3010683 NPL3010764 NPL3010878 NPL3010902 NPL3010904 NPL3010905 NPL3010906 NPL3011113 NPL3011225 NPL3011235 NPL3011236 NPL3011240 NPL3011245 NPL3011246 NPL3011247 NPL3011269 NPL3011297 NPL3011300 NPL3011311 NPL3011314 NPL3011349 NPL3011350 NPL3011362 NPL3011363 NPL3011449 NPL3011452 NPL3011572 NPL3011573 NPL3011600 NPL3011606 NPL3011709 NPL3013655 NPL3013656 NPL3013665 NPL3013669 NPL3013676 NPL3013679 NPL3013683 NPL3013708 NPL3013715 NPL3013721 NPL3013740 NPL3013743 NPL3013746 NPL3013755 NPL3013759 NPL3013782 NPL3013786 NPL3013904 NPL3013913 NPL3013916 NPL3013920 NPL3013967 NPL3013970 NPL3014043 NPL3014064 NPL3014070 NPL3014071 NPL3014073 NPL3014076 NPL3014097 NPL3014098 NPL3014298 NPL3014335 NPL3014345 NPL3014346 NPL3014455 NPL3014456 NPL3014457 NPL3014459 NPL3014500 NPL3014528 NPL3014573 NPL3015558 NPL3016440 NPL3016447 NPL3016476 NPL3016478 NPL3016488 NPL3016506 NPL3016513 NPL3016517 NPL3016606 NPL3016607 NPL3016608 NPL3016610 NPL3016617 NPL3016709 NPL3016710 NPL3016738 NPL3016761 NPL3016776 NPL3016780 NPL3016790 NPL3016793 NPL3016795 NPL3016796 NPL3016800 NPL3017043 NPL3017197 NPL3017200 NPL3017247 NPL3017248 NPL3017252 NPL3017254 NPL3017262 NPL3017266 NPL3017269 NPL3017270 NPL3017274 NPL3017279 NPL3017281 NPL3017285 NPL3017291 NPL3017312 NPL3017313 NPL3017314 NPL3017320 NPL3017413 NPL3017425 NPL3017427 NPL3017431 NPL3017611 NPL3017614 NPL3017689 NPL3017692 NPL3017706 NPL3017727 NPL3017774 NPL3017895 NPL3017897 NPL3017933 NPL3017943 NPL3017992 NPL3018534 NPL3018579 NPL3018709 NPL3018711 NPL3018713 NPL3018715 NPL3018747 NPL3018756 NPL3018763 NPL3018766 NPL3018792 NPL3018809 NPL3018888 NPL3018889 NPL3018892 NPL3018894 NPL3018895 NPL3019548 NPL3019552 NPL3019585 NPL3019586 NPL3019609 NPL3019629 NPL3019630 NPL3019632 NPL3019705 NPL3019731 NPL3020104 NPL3020107 NPL3020108 NPL3020121 NPL3020143 NPL3020168 NPL3020170 NPL3020986 NPL3021015 NPL3021030 NPL3021031 NPL3021272 NPL3021464 NPL3021466 NPL3021565 NPL3021567 NPL3021963 NPL3021970 NPL3021974 NPL3021990 NPL3021993 NPL3021997 NPL3022022 NPL3022044 NPL3022062 NPL3022125 NPL3022279 NPL3022280 NPL3022289 NPL3022325 NPL3022359 NPL3022365 NPL3022717 NPL3022720 NPL3022721 NPL3022725 NPL3022734 NPL3022762 NPL3022791 NPL3022810 NPL3022815 NPL3022831 NPL3022856 NPL3022869 NPL3022873 NPL3022876 NPL3022900 NPL3022903 NPL3022942 NPL3022954 NPL3022972 NPL3022973 NPL3023032 NPL3023043 NPL3023150 NPL3023193 NPL3023205 NPL3023210 NPL3023241 NPL3023250 NPL3023251 NPL3023253 NPL3023256 NPL3023258 NPL3023286 NPL3023287 NPL3023319 NPL3023323 NPL3023330 NPL3023331 NPL3023394 NPL3023422 NPL3023461 NPL3023465 NPL3023469 NPL3023470 NPL3023471 NPL3023473 NPL3023474 NPL3023475 NPL3023498 NPL3023504 NPL3023563 NPL3023593 NPL3023609 NPL3023615 NPL3023649 NPL3023690 NPL3023718 NPL3023722 NPL3023729 NPL3023734 NPL3023748 NPL3023751 NPL3023776 NPL3023784 NPL3023785 NPL3023792 NPL3023936 NPL3023948 NPL3023955 NPL3023964 NPL3023977 NPL3023998 NPL3024031 NPL3024057 NPL3024059 NPL3024099 NPL3024150 NPL3024151 NPL3024195 NPL3024210 NPL3024213 NPL3024214 NPL3024224 NPL3024239 NPL3024254 NPL3024266 NPL3024284 NPL3024290 NPL3024327 NPL3024329 NPL3024344 NPL3024367 NPL3024384 NPL3024393 NPL3024396 NPL3024408 NPL3024409 NPL3024410 NPL3024424 NPL3024428 NPL3024430 NPL3024445 NPL3024452 NPL3024484 NPL3024487 NPL3024504 NPL3024523 NPL3024527 NPL3024531 NPL3024540 NPL3024606 NPL3024615 NPL3024649 NPL3024662 NPL3024664 NPL3024680 NPL3024717 NPL3024729 NPL3024731 NPL3024737 NPL3024766 NPL3024775 NPL3024778 NPL3024782 NPL3024784 NPL3024794 NPL3024797 NPL3024843 NPL3024872 NPL3024889 NPL3024890 NPL3024902 NPL3024903 NPL3024919 NPL3024936 NPL3024948 NPL3024956 NPL3024964 NPL3025021 NPL3025038 NPL3025047 NPL3025050 NPL3025057 NPL3025070 NPL3025097 NPL3025153 NPL3025224 NPL3025240 NPL3025257 NPL3025263 NPL3025268 NPL3025281 NPL3025284 NPL3025339 NPL3025494 NPL3025533 NPL3025588 NPL3025607 NPL3025704 NPL3025725 NPL3025727 NPL3025745 NPL3025795 NPL3025904 NPL3025953 NPL3025975 NPL3026046 NPL3026092 NPL3026099 NPL3026108 NPL3026111 NPL3026127 NPL3026144 NPL3026150 NPL3026152 NPL3026155 NPL3026165 NPL3026171 NPL3026173 NPL3026184 NPL3026199 NPL3026216 NPL3026220 NPL3026244 NPL3026300 NPL3026301 NPL3026315 NPL3026334 NPL3026335 NPL3026355 NPL3026367 NPL3026374 NPL3026412 NPL3026415 NPL3026421 NPL3026423 NPL3026425 NPL3026430 NPL3026435 NPL3026438 NPL3026441 NPL3026442 NPL3026444 NPL3026451 NPL3027482 NPL3027601 NPL3027620 NPL3027635 NPL3027636 NPL3027652 NPL3027658 NPL3027664 NPL3027674 NPL3027684 NPL3027686 NPL3027687 NPL3027726 NPL3027752 NPL3027767 NPL3027770 NPL3027771 NPL3027777 NPL3027790 NPL3027792 NPL3027800 NPL3027826 NPL3027830 NPL3030794 NPL3030837 NPL3030900 NPL3030913 NPL3030950 NPL3030978 NPL3030985 NPL3031013 NPL3031014 NPL3031041 NPL3031056 NPL3031079 NPL3031084 NPL3031096 NPL3031107 NPL3031111 NPL3031113 NPL3031156 NPL3031158 NPL3031225 NPL3031231 NPL3031255 NPL3031265 NPL3031273 NPL3031278 NPL3031290 NPL3031301 NPL3031377 NPL3031383 NPL3031402 NPL3031438 NPL3031471 NPL3031475 NPL3031477 NPL3031599 NPL3031602 NPL3031608 NPL3031609 NPL3031655 NPL3031674 NPL3031680 NPL3031690 NPL3031738 NPL3031748 NPL3031758 NPL3031759 NPL3031760 NPL3031763 NPL3031773 NPL3031790 NPL3031793 NPL3031806 NPL3031809 NPL3031816 NPL3031865 NPL3031874 NPL3031880 NPL3031907 NPL3031914 NPL3031920 NPL3031968 NPL3031979 NPL3031989 NPL3032036 NPL3032048 NPL3032049 NPL3032054 NPL3032077 NPL3032087 NPL3032094 NPL3032106 NPL3032144 NPL3032192 NPL3032193 NPL3032214 NPL3032215 NPL3032223 NPL3032236 NPL3032238 NPL3032240 NPL3032241 NPL3032242 NPL3032243 NPL3032252 NPL3032262 NPL3032273 NPL3032277 NPL3032320 NPL3032326 NPL3032330 NPL3032334 NPL3032344 NPL3032356 NPL3032373 NPL3032382 NPL3032403 NPL3032416 NPL3032476 NPL3032523 NPL3032590 NPL3032600 NPL3032610 NPL3032642 NPL3032648 NPL3032658 NPL3032665 NPL3032668 NPL3032691 NPL3032904 NPL3032954 NPL3032957 NPL3032985 NPL3032991 NPL3033009 NPL3033026 NPL3033105 NPL3033109 NPL3033111 NPL3033136 NPL3033139 NPL3033140 NPL3033217 NPL3033225 NPL3033238 NPL3033247 NPL3033250 NPL3033275 NPL3033276 NPL3033277 NPL3033363 NPL3033371 NPL3033375 NPL3033386 NPL3033463 NPL3033469 NPL3033476 NPL3033484 NPL3033488 NPL3033500 NPL3033504 NPL3033523 NPL3033531 NPL3033581 NPL3033590 NPL3033611 NPL3033622 NPL3033624 NPL3033625 NPL3033628 NPL3033634 NPL3033658 NPL3033773 NPL3033796 NPL3033809 NPL3033815 NPL3033822 NPL3033830 NPL3033839 NPL3033900 NPL3033902 NPL3033911 NPL3033923 NPL3033925 NPL3033964 NPL3033987 NPL3034032 NPL3034042 NPL3034044 NPL3034045 NPL3034119 NPL3034121 NPL3034123 NPL3034130 NPL3034137 NPL3034159 NPL3034171 NPL3034179 NPL3034186 NPL3034191 NPL3034210 NPL3034259 NPL3034272 NPL3034290 NPL3034303 NPL3034331 NPL3034351 NPL3034355 NPL3034368 NPL3034371 NPL3034398 NPL3034402 NPL3034404 NPL3034444 NPL3034452 NPL3034467 NPL3034494 NPL3034495 NPL3034512 NPL3034514 NPL3034515 NPL3034516 NPL3034520 NPL3034523 NPL3034535 NPL3034550 NPL3034556 NPL3034557 NPL3034566 NPL3034595 NPL3034621 NPL3034659 NPL3034685 NPL3034690 NPL3034714 NPL3034737 NPL3034753 NPL3034778 NPL3036810 NPL3036817 NPL3036841 NPL3036932 NPL3037038 NPL3037063 NPL3037066 NPL3037103 NPL3037107 NPL3037112 NPL3037117 NPL3037123 NPL3037124 NPL3037126 NPL3037163 NPL3037225 NPL3037229 NPL3037240 NPL3037241 NPL3037242 NPL3037248 NPL3037251 NPL3037292 NPL3037315 NPL3037321 NPL3037326 NPL3037366 NPL3037382 NPL3037384 NPL3037403 NPL3037405 NPL3037408 NPL3037419 NPL3037426 NPL3037456 NPL3037462 NPL3037465 NPL3037533 NPL3037567 NPL3037568 NPL3037569 NPL3037594 NPL3037611 NPL3037618 NPL3037628 NPL3037715 NPL3037720 NPL3037729 NPL3037764 NPL3037779 NPL3037826 NPL3037828 NPL3037852 NPL3037855 NPL3037858 NPL3037860 NPL3037864 NPL3037870 NPL3037872 NPL3037883 NPL3037902 NPL3037928 NPL3037939 NPL3037965 NPL3037979 NPL3037986 NPL3038012 NPL3038014 NPL3038019 NPL3038078 NPL3038125 NPL3038130 NPL3038175 NPL3038210 NPL3038214 NPL3038216 NPL3038218 NPL3038227 NPL3038228 NPL3038230 NPL3038254 NPL3038265 NPL3038337 NPL3038390 NPL3038432 NPL3038434 NPL3038452 NPL3038457 NPL3038478 NPL3038479 NPL3038510 NPL3038512 NPL3038514 NPL3038519 NPL3038526 NPL3038530 NPL3038531 NPL3038550 NPL3038576 NPL3038580 NPL3038585 NPL3038717 NPL3038719 NPL3038740 NPL3038743 NPL3038745 NPL3038783 NPL3038791 NPL3038827 NPL3038828 NPL3038830 NPL3038832 NPL3038847 NPL3038849 NPL3038851 NPL3038852 NPL3038854 NPL3038856 NPL3038876 NPL3038885 NPL3038888 NPL3038902 NPL3038903 NPL3038905 NPL3038909 NPL3038911 NPL3038919 NPL3038923 NPL3038927 NPL3038953 NPL3038956 NPL3038960 NPL3038964 NPL3038965 NPL3038966 NPL3038982 NPL3038987 NPL3038990 NPL3038992 NPL3039003 NPL3039045 NPL3039058 NPL3039072 NPL3039073 NPL3039074 NPL3039084 NPL3039085 NPL3039090 NPL3039091 NPL3039094 NPL3039097 NPL3039120 NPL3039123 NPL3039127 NPL3039131 NPL3039134 NPL3039137 NPL3039150 NPL3039154 NPL3039156 NPL3039173 NPL3039182 NPL3039183 NPL3039233 NPL3039260 NPL3039267 NPL3039268 NPL3039296 NPL3039305 NPL3039308 NPL3039309 NPL3039310 NPL3039327 NPL3039333 NPL3039334 NPL3039335 NPL3039340 NPL3039352 NPL3039382 NPL3039383 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NPL3040244 NPL3040248 NPL3040254 NPL3040256 NPL3040260 NPL3040327 NPL3040331 NPL3040338 NPL3040368 NPL3040372 NPL3040418 NPL3040456 NPL3040483 NPL3040491 NPL3040518 NPL3040519 NPL3040520 NPL3040521 NPL3040533 NPL3040536 NPL3040550 NPL3040552 NPL3040553 NPL3040555 NPL3040558 NPL3040575 NPL3040590 NPL3040591 NPL3040596 NPL3040608 NPL3040610 NPL3040614 NPL3040629 NPL3040630 NPL3040631 NPL3040637 NPL3040645 NPL3040651 NPL3040657 NPL3040668 NPL3040676 NPL3040677 NPL3040683 NPL3040686 NPL3040687 NPL3040691 NPL3040698 NPL3040699 NPL3040704 NPL3040705 NPL3040726 NPL3040728 NPL3040732 NPL3040738 NPL3040742 NPL3040744 NPL3040749 NPL3040752 NPL3040758 NPL3040760 NPL3040766 NPL3040780 NPL3040793 NPL3040794 NPL3040795 NPL3040800 NPL3040806 NPL3040811 NPL3040813 NPL3040814 NPL3040816 NPL3040817 NPL3040818 NPL3040819 NPL3040847 NPL3040848 NPL3040886 NPL3040910 NPL3040911 NPL3040917 NPL3040920 NPL3040932 NPL3040935 NPL3040936 NPL3040937 NPL3040938 NPL3040944 NPL3040961 NPL3040973 NPL3044942 NPL3044945 NPL3044946 NPL3044961 NPL3044969 NPL3044970 NPL3044972 NPL3044977 NPL3044979 NPL3044995 NPL3044998 NPL3045008 NPL3045010 NPL3045016 NPL3045017 NPL3045022 NPL3045023 NPL3045066 NPL3045070 NPL3045074 NPL3045107 NPL3045110 NPL3045111 NPL3045121 NPL3045127 NPL3045128 NPL3045131 NPL3045133 NPL3045145 NPL3045146 NPL3045147 NPL3045150 NPL3045152 NPL3045153 NPL3045162 NPL3045164 NPL3045178 NPL3045190 NPL3045200 NPL3045201 NPL3045202 NPL3045203 NPL3045222 NPL3045232 NPL3045234
FEI Number 2182207
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
Manufacturer Reason
for Recall		There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn "URGENT: MEDICAL DEVICE CORRECTION" notification letter dated March 2025 was sent to customers. The letter described the product, problem and actions to be taken. Required Actions: When utilizing any of the lead options mentioned above, avoid using the Switch Device feature to transfer data from the Model A71300 Stimulation Trialing CP App to the Model A71400 Stimulation RC CP App. As an alternative, manually enter the patient and lead information using the Model A71400 Stimulation RC CP App, ensuring not to utilize the Switch Device feature. Inform relevant medical staff about the potential of this issue and the steps to mitigate it. Ensure that backup INS devices are readily available for scheduled surgeries. During the implant procedure, check the system integrity before securing the neurostimulator in place as described in the Inceptiv/Intellis Pro Implant Manual. Please complete and return the customer confirmation form enclosed in this letter acknowledging that you have received this information. Please contact Medtronic Technical Services at 1-800-707-0933 if you have any questions regarding this communication.
Quantity in Commerce1493 devices
DistributionWorldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Puerto Rico, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LGW
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