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RecallWatchMedical Device Safety
Class IIOngoingZ-1067-2025

LivaNova USA, Inc. recalls Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva"

LivaNova USA, Inc.Houston, TX, United StatesReported Feb 5, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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)
    UDI-DI 05425025750405
    400 affected lots
    1000054250257504052151721518215190215200215210215220
    +392 more2153021531215322153321534215352153621538021540021541215422154321544215452154621547215482155021551215532155421555215562155821559215602156221563215640215670215680215692157021571215732157521577021580215810215820215832158402158521586215892159002159121593215940215950215972159821599021600021602021603021604021605021606216082160921611021616216172161802162002162121622021625021627021628021629021630021631021632216330216340216352163621637216382163921640216410216422164302164402164502164602164702164821650021651216532165421655216592166021662021663216642166502166702166921670216722167321676216772167821679021680021681216830216842168521686216872168821689216902169121692216932169421695216962169721699217002170121702217042170521706217082171021711217132171421715217182171921720217212172221723217242172521726217282172921731217332173502173621738021749217502175221754217572175821760217622176321766217682176921771217722177421775217762177721778217792178221783217842178621787217882178902179021791217922179421800218012180221803218042182521826218272182921830218322183321834218352183621837218412184421846021849218512185221853218542185521856218572186021861218622186321864218652186621867218700218712187221873218752188021881218822188321884021887218882188921892218942189621898218992190021903219052190721908021909219100219112191221913219140219172191802191902192502192621927219282192921931219322193721940219412194321944219462194721949219500219510219520219540219552195621957219582196002196121963219642196521966219672196821969219702197121973219742197521976021977021978219792198021981219822198321984219862198721988219902199121992219932199421995219962199721998219992200122002220030220042200502200622007220082200922010220132201522016220202202122022220232202622027220282202922030220312203222033220342203722039022040022041022042220432204422045220462204722049220500220510220522205322054022055220570220580220590220600220610220630220640220650220680220690220700220710220720220730220750220760220780220790220800220840220850220860220870220880220890220900220920220950220960220970220980221000221030221050221060

What the firm is doing

On January 3, 2025, LivaNova issued a "Urgent Medical Device Removal" via Mail to affected consignees. LivaNova ask consignees to take the following actions: 1. Monitor the patient for changes in clinical symptoms or if the patient loses perception of stimulation (e.g., the typical cadence for patient visits range from every 3-12 months). 2. Perform system diagnostic testing at each patient office visit to monitor generator battery status. 3. Counsel patients to do the following: i. Notify you if there is a change in perceived clinical symptoms ii. Notify you if they no longer perceive any form of stimulation. iii. Patients with epilepsy who have Magnet Mode enabled should be reminded to use the patient magnet daily to check for the sensation of stimulation to confirm proper generator function, in alignment with recommendations in product labeling for all VNS generator models. Notification Acknowledgement Follow one of the options below to acknowledge receipt of this notification: Option 1 1. Using the QR Code or website address and access code on page 1 of this letter, access your customer page via our secure customer portal ( TRIEVR ) to provide the required information to LivaNova USA, Inc. via a secure, transmission-encrypted system. 2. Answer the question in the Response section indicating your receipt and acknowledgement of the notification. 3. Submit the response by selecting the Send Response button at the bottom of the page.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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