VNS Therapy¿ AspireHC¿ Generator recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial No. (Exp Date): 35283 (01/22/2017), 35339 (01/22/2017), 35354 (01/22/2017), 35355 (01/22/2017), 35458 (01/22/2017), 35474 (01/22/2017), 35487 (01/22/2017), 35492 (01/22/2017), 35561 (01/22/2017), 35565 (01/22/2017), 35568 (01/22/2017), 35603 (01/22/2017), 35614 (02/05/2017), 35615 (02/05/2017), 35617 (02/05/2017), 35618 (02/05/2017), 35624 (02/05/2017), 35625 (02/05/2017), 35634 (02/05/2017), 35705 (02/05/2017), 35706 (02/05/2017), 35767 (02/05/2017), 35771 (02/05/2017), 35774 (02/05/2017), 35795 (02/05/2017), 35797 (02/05/2017), 35801 (02/05/2017), 35807 (02/05/2017), 35826 (02/05/2017), 35856 (02/05/2017), 35857 (02/05/2017), 35862 (02/05/2017), 35864 (02/05/2017), 35887 (02/05/2017), 35888 (02/05/2017), 35890 (02/05/2017), 35891 (02/05/2017), 35900 (02/05/2017), 35904 (02/05/2017), 35905 (02/05/2017), 35906 (02/05/2017), 35908 (02/05/2017), 35909 (02/05/2017), 35910 (02/05/2017), 35911 (02/05/2017), 35913 (02/05/2017), 35914 (02/05/2017), 35915 (02/05/2017), 35926 (02/05/2017), 36060 (05/01/2017), 36067 (02/05/2017), 36068 (02/05/2017), 36073 (02/05/2017), 36082 (02/05/2017), 36084 (02/05/2017), 36085 (02/05/2017), 36090 (02/05/2017), 36132 (02/05/2017), 36140 (02/05/2017), 36141 (02/05/2017), 36143 (02/05/2017), 36151 (02/05/2017), 36983 (05/01/2017), 37596 (04/23/2017), 37873 (04/02/2017), 37882 (04/02/2017), 37883 (04/02/2017), 37917 (04/02/2017), 37929 (04/02/2017), 37973 (04/02/2017), 37978 (04/02/2017), 37979 (04/02/2017), 37980 (04/02/2017), 37982 (04/02/2017), 37983 (04/02/2017), 37986 (04/02/2017), 37991 (04/02/2017), 38048 (04/02/2017), 38052 (04/02/2017), 38061 (04/02/2017), 38102 (04/02/2017), 38130 (04/02/2017), 38139 (04/02/2017), (04/02/2017), 38141 (04/02/2017), 38150 (04/02/2017), 38156 (04/02/2017), 38160 (04/02/2017), 38187 (04/02/2017), 38220 (04/02/2017), 38227 (04/02/2017), 38232 (04/02/2017), 38242 (04/02/2017), 38247 (04/02/2017), 38250 (04/02/2017), 38257 (04/02/2017), 38262 (04/02/2017), 38267 (04/02/2017), 38269 (04/02/2017), 38271 (04/02/2017), 38281 (04/02/2017), 38286 (04/02/2017), 38287 (04/02/2017), 38291 (04/02/2017), 38294 (04/02/2017), 38300 (04/02/2017), 38305 (04/02/2017), 38309 (04/02/2017), 38311 (04/02/2017), 38316 (04/23/2017), 38328 (04/02/2017), 38331 (04/02/2017), 38333 (04/23/2017), 38413 (04/23/2017), 38423 (04/23/2017), 38433 (04/23/2017), 38442 (04/02/2017), 38454 (04/23/2017), 38455 (04/23/2017), 38460 (04/23/2017), 38461 (04/23/2017), 38467 (04/23/2017), 38468 (04/23/2017), 38469 (04/23/2017), 38470 (04/23/2017), 38472 (04/23/2017), 38474 (04/23/2017), 38480 (04/23/2017), 38488 (04/23/2017), 38492 (04/23/2017), 38495 (04/23/2017), 38496 (04/23/2017), 38500 (04/23/2017), 38502 (04/23/2017), 38503 (04/23/2017), 38504 (04/23/2017), 38509 (04/02/2017), 38518 (04/02/2017), 38519 (04/02/2017), 38527 (04/02/2017), 38528 (04/02/2017), 38531 (04/02/2017), 38533 (04/02/2017), 38555 (04/23/2017), 38562 (04/23/2017), 38571 (04/23/2017), 38601 (04/23/2017), 38619 (04/23/2017), 38634 (04/23/2017), 38636 (04/23/2017), 38649 (04/23/2017), 38653 (04/23/2017), 38654 (04/23/2017), 38656 (04/23/2017), 38658 (04/23/2017), 38659 (04/23/2017), 38660 (04/23/2017), 38663 (04/23/2017), 38666 (04/23/2017), 38673 (04/23/2017), 38677 (04/23/2017), 38678 (04/23/2017), 38680 (04/23/2017), 38681 (04/23/2017), 38682 (04/23/2017), 38683 (04/23/2017), 38684 (04/23/2017), 38686 (04/23/2017), 38690 (04/23/2017), 38694 (04/23/2017), 38695 (04/02/2017), 38696 (04/23/2017), 38697 (04/02/2017), 38699 (04/02/2017), 38701 (04/02/2017), 38704 (04/02/2017), 38705 (04/02/2017), 38706 (04/02/2017), 38707 (04/02/2017), 38708 (04/02/2017), 38709 (04/02/2017), 38710 (04/02/2017), 38711 (04/02/2017), 38715 (04/02/2017), 38721 (04/23/2017), 38723 (04/23/2017), (04/23/2017), 38724 (04/23/2017), 38726 (04/23/2017), 38727 (04/23/2017), 38728 (04/23/2017), 38729 (04/23/2017), 38731 (04/23/2017), 38733 (04/02/2017), 38734 (04/23/2017), 38736 (04/23/2017), 38737 (04/23/2017), 38738 (04/02/2017), 38739 (04/02/2017), 38740 (04/02/2017), 38741 (04/02/2017), 38743 (04/02/2017), 38748 (04/23/2017), 38749 (04/23/2017), 38750 (04/23/2017), 38757 (04/23/2017), 38763 (04/02/2017), 38764 (04/02/2017), 38765 (04/02/2017), 38767 (04/02/2017), 38776 (04/02/2017), 38778 (04/02/2017), 38780 (04/02/2017), 38781 (04/02/2017), 38788 (04/02/2017), 38790 (04/02/2017), 38796 (04/02/2017), 38798 (04/02/2017), 38799 (04/02/2017), 38806 (04/02/2017), 38807 (04/02/2017), 38810 (04/02/2017), 38835 (05/01/2017), 38841 (05/01/2017), 38844 (05/01/2017), 38847 (05/01/2017), 38848 (05/01/2017), 38856 (05/01/2017), 38858 (05/01/2017), 38859 (05/01/2017), 38862 (05/01/2017), 38863 (05/01/2017), 38864 (05/01/2017), 38867 (05/01/2017), 38868 (05/01/2017), 38869 (05/01/2017), 38877 (05/01/2017), 38880 (05/01/2017), 38881 (05/01/2017), 38882 (05/01/2017), 38883 (05/01/2017), 38884 (05/01/2017), 38886 (05/01/2017), 38887 (05/01/2017), 38888 (05/01/2017), 38891 (05/01/2017), 38892 (05/01/2017), 38894 (05/01/2017), 38896 (05/01/2017), 38897 (05/01/2017), 38901 (05/01/2017), 38902 (05/01/2017), 38904 (05/01/2017), 38905 (05/01/2017), 38909 (05/01/2017), 38912 (05/01/2017), 38915 (05/01/2017), 38918 (05/01/2017), 38920 (05/01/2017), 38924 (05/01/2017), 38925 (05/01/2017), 38928 (05/01/2017), 38930 (05/01/2017), 38931 (05/01/2017), 38934 (05/01/2017), 38936 (05/01/2017), 38941 (05/01/2017), 38942 (05/01/2017), 38943 (05/01/2017), 38944 (05/01/2017), 38946 (05/01/2017), 38947 (05/01/2017), 38948 (05/01/2017), 38954 (05/01/2017), 38957 (05/01/2017), 38958 (05/01/2017), 38959 (05/01/2017), 38961 (05/01/2017), 38965 (05/01/2017), 38966 (05/01/2017), 38968 (05/01/2017), 38970 (05/01/2017), 38971 (05/01/2017), 38973 (05/01/2017), 38974 (05/01/2017), 38976 (05/01/2017), 38982 (05/01/2017), 38983 (05/01/2017), 38984 (05/01/2017), 38989 (05/01/2017), 38994 (05/01/2017), 38999 (05/01/2017), 39000 (05/01/2017), 39003 (05/01/2017), 39004 (05/01/2017), 39008 (05/01/2017), 39009 (05/01/2017), 39010 (05/01/2017), 39014 (05/01/2017), 39015 (05/01/2017), 39016 (05/01/2017), 39017 (05/01/2017), 39019 (05/01/2017), 39022 (05/01/2017), 39027 (05/01/2017), 39028 (05/01/2017), 39030 (05/01/2017), 39038 (05/01/2017), 39039 (05/01/2017), 39041 (05/01/2017), 39045 (05/01/2017), 39048 (05/01/2017), 39055 (05/01/2017), 39071 (05/01/2017), 39073 (05/01/2017), 39093 (05/01/2017), 39095 (05/01/2017), 39096 (05/01/2017), 39098 (05/01/2017), 39099 (05/01/2017), 39100 (05/01/2017), 39102 (05/01/2017), 39103 (05/01/2017), 39109 (05/01/2017), 39110 (05/01/2017), 39118 (05/01/2017), (05/01/2017), 39154 (05/01/2017), 39157 (05/01/2017), (05/01/2017), 39169 (05/01/2017), 39192 (05/01/2017), 39197 (05/01/2017), 39198 (05/01/2017), 39199 (05/01/2017), 39200 (05/01/2017), 39202 (05/01/2017), 39209 (05/01/2017), 39211 (05/01/2017), 39216 (05/01/2017), 39217 (05/01/2017), 39218 (05/01/2017), 39220 (05/01/2017), 39230 (05/01/2017), 39231 (05/01/2017), 39234 (05/01/2017), 39243 (05/01/2017), 39269 (05/01/2017), 39270 (05/01/2017), 39289 (05/01/2017), 39292 (05/01/2017), 39300 (05/01/2017), 39315 (05/01/2017), 39318 (05/01/2017), 39326 (05/01/2017), 39329 (05/01/2017), 39330 (05/01/2017), 39331 (05/01/2017), 39332 (05/01/2017), 39333 (05/01/2017), 39337 (05/01/2017), 39338 (05/01/2017), 39343 (05/01/2017), 39345 (05/01/2017), 39346 (05/01/2017), 39348 (05/01/2017), 39350 (05/01/2017), 39352 (05/01/2017), 39355 (05/01/2017), 39357 (05/01/2017), 39359 (05/01/2017), 39360 (05/01/2017), 39361 (05/01/2017), 39363 (05/01/2017), 39365 (05/01/2017), 39366 (05/01/2017), 39367 (05/01/2017), 39369 (05/01/2017), 39373 (05/01/2017), 39374 (05/01/2017), 39377 (05/01/2017), 39409 (05/01/2017), 39438 (05/01/2017), 39441 (05/01/2017), 39442 (05/01/2017), 39445 (05/01/2017), 39446 (05/01/2017), 39449 (05/01/2017), 39452 (05/01/2017), 39453 (05/01/2017), 39454 (05/01/2017), 39507 (05/01/2017), 39509 (05/01/2017), 39679 (05/01/2017), 39684 (05/01/2017), 39686 (05/01/2017), 39691 (05/01/2017), 39715 (05/01/2017), 39732 (05/01/2017), 39734 (05/01/2017)

Product

VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA…

Recalling firm

Cyberonics, Inc

Quantity

396 units

Distribution

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.

Recall date

August 23, 2017

Classification

Class II

Status

Terminated

Agency

FDA (device)