LivaNova USA, Inc.: Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for

Hazard

Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

Details from the source

Reason for recall: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR,PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT and the countries of AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN,IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA, Arge Quantity: 8223 units Lot/code info: Lot Code: Model No 1000 UDI-DI: 05425025750405 Lot Numbers/Serial Numbers: 21517 21518 215190 215200 215210 215220 21530 21531 21532 21533 21534 21535 21536 215380 215400 21541 21542 21543 21544 21545 21546 21547 21548 21550 21551 21553 21554 21555 21556 21558 21559 21560 21562 21563 215640 215670 215680 21569 21570 21571 21573 21575 215770 21580 215810 215820 21583 215840 21585 21586 21589 215900 21591 21593 215940 215950 21597 21598 215990 216000 216020 216030 216040 216050 21606 21608 21609 216110 21616 21617 216180 216200 21621 216220 216250 216270 216280 216290 216300 216310 21632 216330 216340 21635 21636 21637 21638 21639 21640 216410 21642 216430 216440 216450 216460 216470 21648 216500 21651 21653 21654 21655 21659 21660 216620 21663 21664 216650 216670 21669 21670 21672 21673 21676 21677 21678 216790 216800 21681 216830 21684 21685 21686 21687 21688 21689 21690 21691 21692 21693 21694 21695 21696 21697 21699 21700 21701 21702 21704 21705 21706 21708 21710 21711 21713 21714 21715 21718 21719 21720 21721 21722 21723 21724 21725 21726 21728 21729 21731 21733 217350 21736 217380 21749 21750 21752 21754 21757 21758 21760 21762 21763 21766 21768 21769 21771 21772 21774 21775 21776 21777 21778 21779 21782 21783 21784 21786 21787 21788 217890 21790 21791 21792 21794 21800 21801 21802 21803 21804 21825 21826 21827 21829 21830 21832 21833 21834 21835 21836 21837 21841 21844 218460 21849 21851 21852 21853 21854 21855 21856 21857 21860 21861 21862 21863 21864 21865 21866 21867

UPC codes

05425025750405

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.