Events

Recall of Device Recall Model 105 Aspire HC and Generators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cyberonics, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77698
  • Event Risk Class
    Class 2
  • Event Number
    Z-3019-2017
  • Event Initiated Date
    2017-06-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157560
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
  • Reason
    Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
  • 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.

Device

Device Recall Model 105 Aspire HC and Generators
  • Model / Serial
    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 Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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.
  • Product Description
    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.
  • Manufacturer
    Cyberonics, Inc

Manufacturer

Cyberonics, Inc
  • Manufacturer Address
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA