Device Recall Model 106 AspireSR Generators

Serial Number Expiration Date: 34898 6/16/2017 34916 6/16/2017 35981 4/16/2017 36098 4/27/2017 36101 4/16/2017 36103 4/16/2017 36309 3/31/2017 36310 3/31/2017 36312 3/31/2017 36395 3/31/2017 36397 3/31/2017 36399 3/31/2017 36406 5/20/2017 36411 5/20/2017 36415 5/20/2017 36416 5/20/2017 36418 5/20/2017 36427 5/20/2017 36428 5/20/2017 36444 3/31/2017 36445 3/31/2017 36461 5/20/2017 36465 5/20/2017 36466 5/20/2017 36467 5/20/2017 36468 5/20/2017 36475 5/20/2017 36491 5/20/2017 36498 5/20/2017 36501 5/26/2017 36502 5/26/2017 36504 5/26/2017 36508 5/26/2017 36512 5/26/2017 36513 5/26/2017 36536 3/31/2017 36538 3/31/2017 36540 3/31/2017 36541 5/20/2017 36542 5/26/2017 36543 5/26/2017 36544 5/26/2017 36545 3/31/2017 36547 3/31/2017 36548 3/31/2017 36549 3/31/2017 36553 3/31/2017 36557 3/31/2017 36559 5/26/2017 36560 3/31/2017 36561 3/31/2017 36562 3/31/2017 36566 3/31/2017 36569 5/26/2017 36570 3/31/2017 36571 3/31/2017 36572 3/31/2017 36573 3/31/2017 36579 3/31/2017 36581 3/31/2017 36583 3/31/2017 36584 3/31/2017 36585 3/31/2017 36589 5/26/2017 36591 5/20/2017 36592 3/31/2017 36594 5/20/2017 36599 5/20/2017 36601 5/20/2017 36602 3/31/2017 36604 5/20/2017 36605 3/31/2017 36606 3/31/2017 36608 3/31/2017 36609 3/31/2017 36610 5/20/2017 36612 3/31/2017 36614 5/20/2017 36616 5/20/2017 36618 5/20/2017 36619 5/20/2017 36625 3/31/2017 36628 5/20/2017 36639 3/31/2017 36760 8/14/2017 36763 8/18/2017 36787 8/11/2017 36790 8/11/2017 36801 8/14/2017 36804 8/20/2017 36839 7/29/2017 36853 8/14/2017 36924 8/14/2017 36926 8/14/2017 36939 8/14/2017 36955 8/18/2017 36958 8/18/2017 36991 8/18/2017 37001 8/18/2017 37017 8/18/2017 37018 8/18/2017 37019 7/29/2017 37021 8/18/2017 37031 8/18/2017 37032 8/18/2017 37082 7/29/2017 37099 7/29/2017 37101 7/29/2017 37102 7/29/2017 37103 7/29/2017 37104 7/29/2017 37107 8/9/2017 37109 8/11/2017 37113 7/29/2017 37137 8/11/2017 37150 8/11/2017 37159 8/9/2017 37166 8/11/2017 37191 8/18/2017 37193 8/18/2017 37194 7/29/2017 37195 7/29/2017 37199 8/9/2017 37215 8/11/2017 37228 7/29/2017 37229 7/29/2017 37233 7/29/2017 37238 8/20/2017 37254 8/14/2017 37262 8/18/2017 37293 8/14/2017 37298 7/29/2017 37308 7/29/2017 37309 7/29/2017 37315 8/11/2017 37318 8/18/2017 37347 8/11/2017 37356 8/18/2017 37386 8/11/2017 37388 7/29/2017 37394 8/20/2017 37407 7/29/2017 37428 8/9/2017 37433 8/9/2017 37440 8/11/2017 37441 8/11/2017 37444 8/11/2017 37447 7/29/2017 37448 8/11/2017 37453 7/29/2017 37460 8/20/2017 37467 7/29/2017 37469 8/11/2017 37470 8/11/2017 37474 7/29/2017 37477 7/29/2017 37478 8/14/2017 37479 7/29/2017 37481 8/14/2017 37492 8/14/2017 37494 7/29/2017 37495 8/14/2017 37496 7/29/2017 37503 7/29/2017 37509 8/20/2017 37514 8/14/2017 37516 7/29/2017 37518 7/29/2017 37519 8/18/2017 37522 8/11/2017 37525 7/29/2017 37527 7/29/2017 37528 7/29/2017 37529 7/29/2017 37531 7/29/2017 37532 7/29/2017 37533 7/29/2017 37534 8/11/2017 37536 8/14/2017 37537 8/14/2017 37547 7/29/2017 37555 8/14/2017 37557 7/29/2017 37580 8/11/2017 37586 8/14/2017 37590 8/20/2017 37593 8/14/2017 37594 7/29/2017 37595 7/29/2017 37599 8/11/2017 37604 8/14/2017 37606 8/14/2017 37613 7/29/2017 37614 8/14/2017 37620 8/14/2017 37623 8/14/2017 37630 7/29/2017 37638 7/29/2017 37641 7/29/2017 37642 8/11/2017 37643 8/14/2017 37646 8/9/2017 37647 7/29/2017 37648 7/29/2017 37651 8/14/2017 37652 7/29/2017 37655 8/11/2017 37658 7/29/2017 37670 7/29/2017 37675 8/18/2017 37684 7/29/2017 37685 7/29/2017 37687 7/29/2017 37688 7/29/2017 37690 8/11/2017 37698 7/29/2017 37699 7/29/2017 37700 7/29/2017 37701 7/29/2017 37702 7/29/2017 37704 7/29/2017 37705 7/29/2017 37711 7/29/2017 37714 7/29/2017 37715 7/29/2017 37716 7/29/2017 37717 7/29/2017 37718 7/29/2017 37721 8/18/2017 37728 8/18/2017 37729 8/18/2017 37861 3/31/2017 37869 3/31/2017 37875 3/31/2017 37878 3/31/2017 37888 4/16/2017 37896 4/16/2017 37897 4/16/2017 37898 4/16/2017 37899 4/16/2017 37900 4/27/2017 37902 3/31/2017 37903 3/31/2017 37904 3/31/2017 37906 3/31/2017 37907 3/31/2017 37910 4/27/2017 37911 4/27/2017 37912 3/31/2017 37919 4/27/2017 37922 3/31/2017 37924 3/31/2017 37927 4/27/2017 37928 4/16/2017 37930 4/16/2017 37931 4/16/2017 37932 3/31/2017 37933 4/16/2017 37934 4/16/2017 37935 4/16/2017 37936 3/31/2017 37938 4/16/2017 37939 4/16/2017 37940 3/31/2017 37942 4/16/2017 37944 4/16/2017 37945 4/16/2017 37946 4/16/2017 37947 4/16/2017 37949 4/16/2017 37950 4/16/2017 37951 3/31/2017 37952 4/16/2017 37953 3/31/2017 37954 4/16/2017 37955 4/16/2017 37957 3/31/2017 37958 4/16/2017 37959 4/16/2017 37960 3/31/2017 37961 3/31/2017 37962 4/16/2017 37963 3/31/2017 37964 4/27/2017 37966 3/31/2017 37968 3/31/2017 37969 4/16/2017 37970 3/31/2017 37971 4/16/2017 37972 3/31/2017 37976 4/16/2017 37981 4/27/2017 37989 4/16/2017 38006 4/16/2017 38007 4/16/2017 38009 4/27/2017 38018 3/31/2017 38019 4/16/2017 38020 4/16/2017 38028 4/16/2017 38029 4/16/2017 38030 4/16/2017 38032 4/16/2017 38038 4/16/2017 38039 4/16/2017 38040 3/31/2017 38050 4/16/2017 38053 4/16/2017 38055 4/16/2017 38057 4/16/2017 38058 4/16/2017 38059 4/16/2017 38062 4/16/2017 38067 4/16/2017 38070 4/16/2017 38071 4/16/2017 38072 4/16/2017 38073 4/16/2017 38075 4/16/2017 38076 4/16/2017 38077 4/16/2017 38078 3/31/2017 38080 4/16/2017 38081 4/16/2017 38082 4/16/2017 38085 4/16/2017 38090 4/16/2017 38092 4/16/2017 38093 4/16/2017 38095 4/16/2017 38096 3/31/2017 38097 4/27/2017 38098 4/16/2017 38099 4/27/2017 38101 4/27/2017 38106 4/27/2017 38107 4/16/2017 38112 4/16/2017 38113 3/31/2017 38114 4/16/2017 38115 3/31/2017 38116 4/16/2017 38117 4/27/2017 38118 4/16/2017 38119 4/27/2017 38120 3/31/2017 38121 3/31/2017 38123 4/16/2017 38124 4/16/2017 38125 3/31/2017 38127 3/31/2017 38131 4/16/2017 38133 4/27/2017 38134 4/27/2017 38136 3/31/2017 38137 4/16/2017 38140 4/16/2017 38144 3/31/2017 38145 3/31/2017 38146 4/16/2017 38147 4/16/2017 38151 3/31/2017 38157 4/16/2017 38158 4/27/2017 38159 4/16/2017 38164 3/31/2017 38165 3/31/2017 38166 3/31/2017 38167 4/16/2017 38177 3/31/2017 38179 4/16/2017 38182 4/16/2017 38186 3/31/2017 38188 3/31/2017 38189 3/31/2017 38190 4/16/2017 38193 4/16/2017 38195 4/27/2017 38196 4/27/2017 38197 4/27/2017 38199 4/16/2017 38200 4/27/2017 38201 3/31/2017 38202 4/16/2017 38204 4/27/2017 38207 4/27/2017 38209 4/16/2017 38211 4/27/2017 38214 4/16/2017 38223 4/29/2017 38225 5/8/2017 38231 4/29/2017 38233 4/29/2017 38235 4/27/2017 38236 4/27/2017 38237 4/29/2017 38253 4/27/2017 38254 4/29/2017 38255 4/27/2017 38256 4/27/2017 38258 4/29/2017 38259 4/27/2017 38265 4/27/2017 38310 4/29/2017 38317 4/29/2017 38318 4/29/2017 38322 5/8/2017 38334 4/29/2017 38335 4/27/2017 38336 4/27/2017 38337 4/27/2017 38339 4/29/2017 38340 4/27/2017 38341 4/27/2017 38343 4/27/2017 38345 4/27/2017 38346 4/27/2017 38347 4/27/2017 38349 4/27/2017 38350 4/27/2017 38351 4/29/2017 38352 4/27/2017 38355 5/8/2017 38356 4/29/2017 38357 4/29/2017 38359 4/29/2017 38360 4/27/2017 38363 5/8/2017 38366 4/27/2017 38367 4/29/2017 38368 4/27/2017 38369 4/29/2017 38370 5/8/2017 38371 4/27/2017 38372 4/29/2017 38373 4/29/2017 38374 4/29/2017 38375 4/27/2017 38376 4/29/2017 38377 4/27/2017 38378 4/27/2017 38379 4/27/2017 38380 4/27/2017 38381 4/27/2017 38382 4/29/2017 38383 4/29/2017 38384 4/27/2017 38385 4/27/2017 38387 4/16/2017 38388 4/29/2017 38390 5/20/2017 38391 5/20/2017 38392 4/27/2017 38393 4/27/2017 38396 4/29/2017 38397 4/29/2017 38398 4/16/2017 38400 4/29/2017 38401 4/27/2017 38402 4/29/2017 38403 4/27/2017 38404 4/27/2017 38406 4/27/2017 38407 4/27/2017 38408 4/29/2017 38411 4/29/2017 38414 4/27/2017 38415 4/27/2017 38416 4/29/2017 38417 4/27/2017 38418 4/27/2017 38419 4/27/2017 38420 4/29/2017 38425 4/27/2017 38426 4/27/2017 38427 4/27/2017 38428 4/27/2017 38429 4/27/2017 38430 4/27/2017 38431 5/8/2017 38432 4/27/2017 38434 4/27/2017 38435 4/27/2017 38436 4/27/2017 38438 4/27/2017 38440 4/29/2017 38441 4/27/2017 38447 4/27/2017 38448 4/27/2017 38449 4/29/2017 38450 4/29/2017 38452 4/27/2017 38456 4/29/2017 38458 5/8/2017 38462 5/8/2017 38465 5/8/2017 38478 5/8/2017 38479 5/8/2017 38481 5/20/2017 38484 5/20/2017 38485 5/20/2017 38489 4/29/2017 38493 4/29/2017 38497 5/20/2017 38498 5/8/2017 38501 5/20/2017 38506 4/29/2017 38510 4/29/2017 38511 5/20/2017 38513 5/8/2017 38521 5/8/2017 38522 5/8/2017 38524 5/8/2017 38525 4/29/2017 38534 5/8/2017 38539 5/8/2017 38540 4/29/2017 38545 4/29/2017 38546 5/20/2017 38552 5/8/2017 38553 5/8/2017 38554 5/8/2017 38566 5/8/2017 38567 5/8/2017 38568 4/29/2017 38569 5/8/2017 38573 4/29/2017 38574 4/29/2017 38575 5/8/2017 38576 5/20/2017 38577 5/28/2017 38578 6/3/2017 38579 5/20/2017 38580 5/20/2017 38581 5/20/2017 38582 5/26/2017 38584 5/26/2017 38586 5/20/2017 38587 5/20/2017 38588 5/20/2017 38589 5/20/2017 38590 5/8/2017 38591 5/20/2017 38592 5/26/2017 38595 5/20/2017 38597 5/8/2017 38599 4/29/2017 38600 4/29/2017 38603 5/8/2017 38604 4/29/2017 38605 5/8/2017 38606 5/20/2017 38607 5/20/2017 38608 4/29/2017 38610 5/13/2017 38612 6/16/2017 38616 4/29/2017 38617 5/8/2017 38621 4/29/2017 38622 5/13/2017 38626 4/29/2017 38629 4/29/2017 38631 4/29/2017 38632 4/29/2017 38633 5/8/2017 38637 4/29/2017 38639 4/29/2017 38641 5/13/2017 38642 5/20/2017 38643 5/8/2017 38644 5/20/2017 38646 4/29/2017 38648 4/29/2017 38652 5/20/2017 38664 5/20/2017 38665 5/20/2017 38667 5/20/2017 38668 5/20/2017 38669 4/29/2017 38674 5/20/2017 38675 5/20/2017 38685 4/29/2017 38687 4/29/2017 38688 4/29/2017 38700 5/20/2017 38716 5/20/2017 38717 5/13/2017 38746 5/13/2017 38756 5/20/2017 38762 5/20/2017 38769 5/20/2017 38770 5/13/2017 38783 4/29/2017 38785 4/29/2017 38786 5/20/2017 38791 5/20/2017 38792 5/20/2017 38793 5/20/2017 38803 5/20/2017 38922 5/28/2017 38923 5/28/2017 38929 5/28/2017 38932 5/20/2017 38933 5/20/2017 38938 5/20/2017 38950 5/26/2017 38956 5/20/2017 38963 5/20/2017 38964 5/20/2017 38979 5/13/2017 38992 5/20/2017 38993 5/13/2017 38995 5/20/2017 38996 5/20/2017 38998 5/20/2017 39001 5/20/2017 39011 5/13/2017 39013 5/13/2017 39021 5/13/2017 39024 5/13/2017 39034 5/13/2017 39035 5/13/2017 39043 5/13/2017 39049 5/20/2017 39050 5/20/2017 39051 5/26/2017 39052 5/20/2017 39056 5/26/2017 39058 5/26/2017 39063 5/26/2017 39064 5/26/2017 39066 5/20/2017 39067 5/20/2017 39070 5/20/2017 39074 5/26/2017 39075 5/20/2017 39077 6/23/2017 39080 5/20/2017 39085 5/13/2017 39097 5/26/2017 39112 5/26/2017 39113 5/26/2017 39114 5/26/2017 39115 5/20/2017 39116 5/20/2017 39117 5/26/2017 39119 5/20/2017 39120 5/20/2017 39122 5/20/2017 39123 5/26/2017 39124 5/20/2017 39126 5/26/2017 39131 5/20/2017 39133 5/20/2017 39134 5/20/2017 39135 5/26/2017 39136 5/20/2017 39137 5/28/2017 39139 5/28/2017 39152 5/28/2017 39153 5/28/2017 39201 5/20/2017 39204 5/20/2017 39205 5/20/2017 39206 5/20/2017 39210 5/20/2017 39212 5/20/2017 39213 5/13/2017 39214 5/20/2017 39215 5/20/2017 39221 5/20/2017 39223 5/20/2017 39225 5/20/2017 39236 5/20/2017 39242 5/13/2017 39260 6/23/2017 39262 5/20/2017 39264 6/3/2017 39265 5/20/2017 39266 5/20/2017 39267 6/3/2017 39268 5/20/2017 39273 5/20/2017 39274 6/23/2017 39275 6/11/2017 39276 6/23/2017 39278 6/3/2017 39281 5/20/2017 39282 5/20/2017 39284 5/20/2017 39285 6/11/2017 39291 6/3/2017 39293 6/23/2017 39294 6/23/2017 39295 6/23/2017 39296 6/23/2017 39297 6/11/2017 39299 6/11/2017 39301 6/11/2017 39302 7/3/2017 39303 6/11/2017 39304 6/11/2017 39305 6/11/2017 39306 6/11/2017 39307 6/11/2017 39309 6/11/2017 39311 6/3/2017 39312 6/11/2017 39314 6/16/2017 39316 6/11/2017 39321 6/16/2017 39322 6/16/2017 39327 6/23/2017 39342 6/23/2017 39351 6/11/2017 39353 6/3/2017 39356 6/23/2017 39370 7/3/2017 39371 6/23/2017 39372 6/23/2017 39378 7/7/2017 39380 6/3/2017 39381 6/16/2017 39383 6/11/2017 39386 5/20/2017 39391 6/16/2017 39393 6/16/2017 39394 6/3/2017 39395 6/16/2017 39398 5/20/2017 39399 7/7/2017 39400 5/20/2017 39402 5/20/2017 39405 7/7/2017 39406 5/28/2017 39407 5/20/2017 39416 6/3/2017 39417 5/20/2017 39418 5/20/2017 39419 5/28/2017 39422 5/28/2017 39424 6/10/2017 39430 6/10/2017 39431 5/28/2017 39433 5/28/2017 39434 5/20/2017 39437 5/20/2017 39443 7/3/2017 39444 6/23/2017 39447 5/28/2017 39448 5/28/2017 39450 5/20/2017 39457 6/3/2017 39459 6/10/2017 39460 5/28/2017 39461 6/10/2017 39462 5/20/2017 39464 6/3/2017 39468 6/3/2017 39471 7/3/2017 39472 7/3/2017 39474 6/3/2017 39476 5/20/2017 39479 6/23/2017 39480 6/16/2017 39482 7/8/2017 39484 6/3/2017 39485 7/3/2017 39487 5/20/2017 39488 7/7/2017 39489 7/8/2017 39491 7/8/2017 39492 6/23/2017 39493 6/16/2017 39494 7/7/2017 39496 6/16/2017 39497 5/28/2017 39498 5/28/2017 39500 5/20/2017 39501 7/7/2017 39503 7/7/2017 39506 6/3/2017 39510 5/28/2017 39512 6/3/2017 39513 6/23/2017 39515 6/10/2017 39516 6/10/2017 39518 6/3/2017 39519 6/10/2017 39520 6/10/2017 39524 6/10/2017 39525 7/2/2017 39527 7/2/2017 39528 7/2/2017 39531 6/23/2017 39534 7/2/2017 39536 7/2/2017 39537 7/2/2017 39538 7/2/2017 39539 7/2/2017 39540 7/2/2017 39541 7/16/2017 39542 7/2/2017 39543 6/23/2017 39544 6/23/2017 39545 6/23/2017 39546 6/11/2017 39547 6/11/2017 39549 6/11/2017 39550 6/11/2017 39551 6/11/2017 39552 6/23/2017 39553 6/23/2017 39555 7/7/2017 39556 6/11/2017 39557 6/23/2017 39558 5/28/2017 39559 7/16/2017 39560 6/23/2017 39561 6/11/2017 39562 6/10/2017 39563 6/10/2017 39564 6/23/2017 39567 6/23/2017 39568 7/2/2017 39571 6/23/2017 39572 6/23/2017 39575 5/28/2017 39576 6/11/2017 39577 6/23/2017 39578 6/11/2017 39579 6/11/2017 39580 6/23/2017 39582 6/3/2017 39585 5/28/2017 39586 6/11/2017 39587 6/11/2017 39588 6/11/2017 39589 6/3/2017 39591 6/11/2017 39592 6/23/2017 39593 6/23/2017 39594 6/23/2017 39595 5/28/2017 39596 6/23/2017 39597 6/11/2017 39598 6/11/2017 39600 6/11/2017 39601 6/11/2017 39602 6/11/2017 39603 6/16/2017 39606 6/23/2017 39607 5/8/2017 39608 7/2/2017 39609 5/20/2017 39610 6/11/2017 39611 6/16/2017 39612 6/23/2017 39613 6/16/2017 39614 6/23/2017 39615 5/28/2017 39616 7/2/2017 39618 6/23/2017 39619 6/23/2017 39620 5/13/2017 39621 5/13/2017 39622 6/16/2017 39624 6/23/2017 39628 6/16/2017 39630 6/10/2017 39631 5/13/2017 39633 5/13/2017 39637 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Neurological Devices

3

Yes

Worldwide Distribution - US Nationwide and Puerto Rico and the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Puerto Rico. Distribution internationally to Argentina, Austria, Belgium, Canada, Croatia, Czech Republic, Finland, Germany, Ireland, Israel, Italy, Japan, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, United Arab Emirates, and United Kingdom.

VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. || Product Usage: || United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode