Cyberonics, Inc: VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. 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.

Recall number

Z-3019-2017

Recalling firm

Cyberonics, Inc

Product

VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. 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.

Status

Terminated

Initiated

2017-06-13

Posted

not on file

Terminated

2023-04-27

Reason

Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.

Root cause

Manufacturing material removal

Action

Affected hospitals were notified beginning on 06/13/2017 and prescribing physicians were notified beginning on 06/28/2017. Instructions for affected hospitals included examine inventory, quarantine any affected devices, return the devices, complete and return the response form. Instructions for prescribing physicians included to monitory patients frequently and perform diagnostic testing at each visit, ensure patients are using the device regularly to verify stimulation is felt, ensure patients notify their physician if stimulation changes, and complete and return the response form.

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.

Lot, serial or model codes

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)

510(k) numbers

not on file

PMA numbers

["P970003S117"]

Product code

LYJ

Firm FEI

1000117004

Firm city

Houston

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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