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U.S. Department of Health and Human Services

Class 2 Device Recall Model 105 Aspire HC and Generators

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  Class 2 Device Recall Model 105 Aspire HC and Generators see related information
Date Initiated by Firm June 13, 2017
Create Date August 11, 2017
Recall Status1 Open3, Classified
Recall Number Z-3019-2017
Recall Event ID 77698
PMA Number P970003S117 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
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.
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 (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), 38
Recalling Firm/
Manufacturer
Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact
866-882-8804
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.
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