FDA Medical devices recall · February 5, 2025

SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model recall

Read the official FDA notice ↗

Product

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 Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

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, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Luxembourg, New Zealand, Norway, Panama, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands, Turkey, UAE, United Kingdom.

States: Alaska Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1067-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.