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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77698

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 13, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cyberonics, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-3019-2017
Recall number
Z-3019-2017
Initiated
June 13, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cyberonics, Inc
Quantity
396 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Manufacturing material removal

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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 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Distribution pattern

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.

device · product 2 of 2

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

Z-3020-2017
Recall number
Z-3020-2017
Initiated
June 13, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cyberonics, Inc
Quantity
1,909 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Manufacturing material removal

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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 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40775 7/15/2017 40779 7/20/2017 40810 7/20/2017 40811 7/20/2017 40815 7/20/2017 40816 7/20/2017 40820 7/20/2017 40821 7/20/2017 40826 7/17/2017 40858 7/20/2017 40859 7/21/2017 40864 7/20/2017 40865 7/15/2017 40867 7/15/2017 40885 7/20/2017 40901 7/20/2017 40903 7/20/2017 40907 7/20/2017 40909 7/21/2017 40916 7/20/2017 40918 7/20/2017 40924 7/17/2017 40925 7/20/2017 40928 7/21/2017 40929 7/21/2017 40938 8/7/2017 40939 7/21/2017 40945 7/16/2017 40946 7/16/2017 40947 7/15/2017 40948 8/7/2017 40954 7/21/2017 40955 7/20/2017 40957 7/20/2017 40958 7/20/2017 40960 7/21/2017 40961 7/21/2017 40962 8/7/2017 40963 7/20/2017 40965 7/21/2017 40967 7/20/2017 40968 7/20/2017 40976 7/21/2017 40978 7/21/2017 40980 7/21/2017 40981 7/21/2017 40992 7/21/2017 40994 7/21/2017 40995 7/21/2017 41000 7/21/2017 41001 8/7/2017 41005 7/21/2017 41007 7/30/2017 41008 8/7/2017 41012 7/21/2017 41013 7/21/2017 41014 7/21/2017 41017 7/21/2017 41018 7/21/2017 41019 7/21/2017 41023 7/20/2017 41024 7/21/2017 41025 7/21/2017 41026 8/7/2017 41034 7/21/2017 41037 7/20/2017 41038 7/20/2017 41040 7/21/2017 41046 7/21/2017 41047 7/20/2017 41050 7/20/2017 41053 7/21/2017 41056 8/7/2017 41058 7/20/2017 41063 7/21/2017 41069 7/21/2017 41091 8/18/2017 41092 7/20/2017 41100 7/20/2017 41101 7/20/2017 41110 7/20/2017 41115 7/20/2017 41117 7/20/2017 41122 8/7/2017 41134 7/30/2017 41135 8/5/2017 41138 7/20/2017 41141 8/5/2017 41142 8/5/2017 41147 8/5/2017 41158 7/20/2017 41161 8/7/2017 41168 7/30/2017 41183 8/5/2017 41187 7/20/2017 41188 7/20/2017 41222 8/7/2017 41226 7/30/2017 41227 8/7/2017 41233 7/30/2017 41235 8/7/2017 41236 7/30/2017 41237 7/30/2017 41238 8/7/2017 41241 7/30/2017 41242 7/30/2017 41243 7/30/2017 41244 7/30/2017 41245 8/7/2017 41252 7/30/2017 41268 7/30/2017 41276 7/30/2017 41278 7/30/2017 41279 7/30/2017 41280 8/7/2017 41281 8/5/2017 41284 7/30/2017 41285 7/30/2017 41287 7/30/2017 41289 7/30/2017 41291 8/5/2017 41293 7/30/2017 41296 7/30/2017 41297 7/30/2017 41298 8/7/2017 41302 7/30/2017 41304 8/5/2017 41306 8/7/2017 41307 8/7/2017 41308 8/5/2017 41309 7/30/2017 41313 8/7/2017 41314 8/7/2017 41316 8/7/2017 41317 8/7/2017 41318 8/7/2017 41325 8/7/2017 41333 8/7/2017 41334 8/7/2017 41336 8/7/2017 41362 8/7/2017 41369 7/30/2017 41371 7/30/2017 41372 8/7/2017 41375 8/7/2017 41377 7/30/2017 41378 8/5/2017 41379 7/30/2017 41383 8/7/2017 41384 8/7/2017 41393 8/7/2017 41395 8/7/2017 41397 8/7/2017 41399 8/7/2017 41402 8/7/2017 41404 7/30/2017 41405 7/30/2017 41406 8/7/2017 41407 8/7/2017 41409 8/7/2017 41410 8/7/2017 41411 8/7/2017 41412 8/7/2017 41414 7/30/2017 41415 8/7/2017 41416 8/5/2017 41417 8/5/2017 41419 8/5/2017 41423 8/7/2017 41424 8/7/2017 41426 7/30/2017 41430 8/7/2017 41436 8/7/2017 41443 8/7/2017 41473 8/7/2017 41474 8/7/2017 41481 8/7/2017 41482 8/7/2017 41489 8/7/2017 41490 8/7/2017 41491 8/7/2017 41492 8/7/2017 41497 8/7/2017 41498 8/7/2017 41500 8/5/2017 41502 8/7/2017 41507 8/7/2017 41509 8/7/2017 41510 8/7/2017 41511 8/7/2017 41512 8/7/2017 41515 8/7/2017 41516 8/7/2017 41530 8/5/2017 41533 8/5/2017 41543 8/5/2017 41545 8/7/2017 41549 7/30/2017 41550 8/5/2017 41553 8/7/2017 41554 7/30/2017 41575 8/31/2017 41619 8/7/2017 41621 8/7/2017 41622 8/7/2017 41625 8/7/2017 41628 8/7/2017 41634 8/5/2017 41643 8/5/2017 41648 8/7/2017 41649 8/5/2017 41650 8/7/2017 41652 8/7/2017 41653 8/11/2017 41655 8/7/2017 41657 8/7/2017 41659 8/7/2017 41660 8/5/2017 41674 8/5/2017 41675 8/5/2017 41676 8/7/2017 41678 8/5/2017 41679 8/7/2017 41682 8/5/2017 41684 8/7/2017 41685 8/5/2017 41686 8/5/2017 41687 8/5/2017 41689 8/7/2017 41693 8/5/2017 41695 8/5/2017 41698 8/5/2017 41701 7/30/2017 41705 8/7/2017 41709 8/5/2017 41710 8/5/2017 41711 8/5/2017 41712 8/5/2017 41713 8/7/2017 41714 8/5/2017 41720 8/7/2017 41722 8/7/2017 41731 8/7/2017 41733 8/7/2017 41734 8/7/2017 41736 8/5/2017 41739 7/30/2017 41742 8/7/2017 41744 8/7/2017 41745 7/30/2017 41746 7/30/2017 41750 7/30/2017 41752 8/7/2017 41754 7/30/2017 41755 8/7/2017 41757 8/7/2017 41761 8/7/2017 41766 7/30/2017 41770 7/30/2017 41771 8/7/2017 41774 8/5/2017 41777 8/7/2017 41780 7/30/2017 41782 7/30/2017 41783 7/30/2017 41784 7/30/2017 41785 7/30/2017 41787 7/30/2017 41788 7/30/2017 41789 7/30/2017 41790 7/30/2017 41793 7/30/2017 41794 7/30/2017 41795 7/30/2017 41796 7/30/2017 41797 7/30/2017 41799 7/30/2017 41800 7/30/2017 41801 7/30/2017 41805 7/30/2017 41806 7/30/2017 41809 7/30/2017 41810 7/30/2017 41816 7/30/2017 41817 7/30/2017 41818 7/30/2017 41824 8/7/2017 41825 7/30/2017 41826 8/5/2017 41827 7/30/2017 41828 7/30/2017 41829 7/30/2017 41830 7/30/2017 41835 8/7/2017 41837 7/30/2017 41838 7/30/2017 41843 8/7/2017 41845 8/5/2017 41851 7/30/2017 41853 7/30/2017 41854 7/30/2017 41855 7/30/2017 41861 8/7/2017 41868 8/5/2017 41877 8/7/2017 41883 8/7/2017 41886 8/5/2017 41888 8/5/2017 41891 8/5/2017 41898 8/7/2017 41909 8/5/2017 41914 8/5/2017 41919 8/5/2017 41935 8/5/2017 41941 8/5/2017 41945 8/7/2017 41949 8/5/2017 41950 8/7/2017 41954 8/5/2017 41955 8/5/2017 41958 8/5/2017 41963 8/5/2017 41968 8/5/2017 41969 8/5/2017 41970 8/5/2017 41971 8/5/2017 41972 8/5/2017 41977 8/5/2017 41980 8/5/2017 41982 8/5/2017 41984 8/5/2017 41985 8/5/2017 41986 8/5/2017 41987 8/5/2017 41989 8/5/2017 41990 8/7/2017 41991 8/7/2017 41992 8/5/2017 41993 8/5/2017 41994 8/5/2017 41997 8/7/2017 42000 8/5/2017 42003 8/7/2017 42006 8/5/2017 42008 8/5/2017 42010 8/5/2017 42011 8/5/2017 42013 8/5/2017 42014 8/5/2017 42017 8/7/2017 42019 8/7/2017 42022 8/5/2017 42023 8/5/2017 42034 8/7/2017 42041 8/11/2017 42044 8/11/2017 42045 8/11/2017 42047 8/7/2017 42048 8/7/2017 42061 8/7/2017 42064 8/5/2017 42074 8/7/2017 42077 8/7/2017 42087 8/5/2017 42091 8/7/2017 42102 8/7/2017 42103 8/7/2017 42109 8/7/2017 42110 8/5/2017 42113 8/7/2017 42117 8/11/2017 42118 8/11/2017 42122 8/11/2017 42123 8/11/2017 42125 8/11/2017 42128 8/11/2017 42131 8/11/2017 42136 8/11/2017 42137 8/11/2017 42138 8/11/2017 42142 8/11/2017 42153 8/31/2017 42161 8/31/2017 42163 8/31/2017 42264 8/5/2017 42265 8/5/2017 42266 8/7/2017 42270 8/5/2017 42272 8/5/2017 42273 8/7/2017 42276 8/5/2017 42277 8/5/2017 42280 8/7/2017 42285 8/5/2017 42286 8/5/2017 42287 8/7/2017 42289 8/7/2017 42290 8/5/2017 42291 8/5/2017 42294 8/14/2017 42295 8/7/2017 42300 8/5/2017 42301 8/5/2017 42302 8/7/2017 42312 8/14/2017 42313 8/18/2017 42324 8/14/2017 42327 8/14/2017 42333 8/14/2017 42334 8/14/2017 42335 8/14/2017 42346 8/14/2017 42349 8/18/2017 42350 8/14/2017 42351 8/14/2017 42352 8/18/2017 42395 8/18/2017 42403 8/18/2017 42412 8/18/2017 42420 8/7/2017 42443 8/5/2017 42533 8/14/2017 42623 8/26/2017 42626 8/18/2017 42650 8/18/2017 42651 8/18/2017 42665 8/18/2017 42668 8/18/2017 42670 8/14/2017 42677 8/20/2017 42678 8/18/2017 42687 8/18/2017 42693 8/31/2017 42695 8/31/2017 42701 8/18/2017 42705 8/18/2017 42797 8/20/2017 42806 8/20/2017 42874 8/31/2017 42907 8/31/2017 42913 8/31/2017 42922 8/31/2017 42984 8/31/2017 42990 8/31/2017 43052 8/31/2017 43105 8/31/2017 43112 8/31/2017 43128 8/31/2017 43149 8/31/2017 43150 8/31/2017 43154 8/31/2017 43168 8/31/2017

Distribution pattern

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.

Field note

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