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

Recall details

Manufacturer

Cyberonics, Inc

Distributor

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 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 37215 8/11/2017 37228 7/29/2017 37229 7/29/2017 37233 7/29/2017 37238 8/20/2017 37254 8/14/2017 37262 8/18/2017 37293 8/14/2017 37298 7/29/2017 37308 7/29/2017 37309 7/29/2017 37315 8/11/2017 37318 8/18/2017 37347 8/11/2017 37356 8/18/2017 37386 8/11/2017 37388 7/29/2017 37394 8/20/2017 37407 7/29/2017 37428 8/9/2017 37433 8/9/2017 37440 8/11/2017 37441 8/11/2017 37444 8/11/2017 37447 7/29/2017 37448 8/11/2017 37453 7/29/2017 37460 8/20/2017 37467 7/29/2017 37469 8/11/2017 37470 8/11/2017 37474 7/29/2017 37477 7/29/2017 37478 8/14/2017 37479 7/29/2017 37481 8/14/2017 37492 8/14/2017 37494 7/29/2017 37495 8/14/2017 37496 7/29/2017 37503 7/29/2017 37509 8/20/2017 37514 8/14/2017 37516 7/29/2017 37518 7/29/2017 37519 8/18/2017 37522 8/11/2017 37525 7/29/2017 37527 7/29/2017 37528 7/29/2017 37529 7/29/2017 37531 7/29/2017 37532 7/29/2017 37533 7/29/2017 37534 8/11/2017 37536 8/14/2017 37537 8/14/2017 37547 7/29/2017 37555 8/14/2017 37557 7/29/2017 37580 8/11/2017 37586 8/14/2017 37590 8/20/2017 37593 8/14/2017 37594 7/29/2017 37595 7/29/2017 37599 8/11/2017 37604 8/14/2017 37606 8/14/2017 37613 7/29/2017 37614 8/14/2017 37620 8/14/2017 37623 8/14/2017 37630 7/29/2017 37638 7/29/2017 37641 7/29/2017 37642 8/11/2017 37643 8/14/2017 37646 8/9/2017 37647 7/29/2017 37648 7/29/2017 37651 8/14/2017 37652 7/29/2017 37655 8/11/2017 37658 7/29/2017 37670 7/29/2017 37675 8/18/2017 37684 7/29/2017 37685 7/29/2017 37687 7/29/2017 37688 7/29/2017 37690 8/11/2017 37698 7/29/2017 37699 7/29/2017 37700 7/29/2017 37701 7/29/2017 37702 7/29/2017 37704 7/29/2017 37705 7/29/2017 37711 7/29/2017 37714 7/29/2017 37715 7/29/2017 37716 7/29/2017 37717 7/29/2017 37718 7/29/2017 37721 8/18/2017 37728 8/18/2017 37729 8/18/2017 37861 3/31/2017 37869 3/31/2017 37875 3/31/20

Risk classification

Class II

Area (FDA)

device

Country

United States