Home / Recalls / LivaNova USA, Inc. / Z-1068-2025

Z-1068-2025 Class II Ongoing

Recalled by LivaNova USA, Inc. — Houston, TX

FDA device recall Z-1068-2025 was initiated by LivaNova USA, Inc. on January 3, 2025 and is designated Class II. Reason for recall: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. The recall status is ongoing. Affected quantity: 84 units.

Recall Details

Product Type
Devices
Report Date
February 5, 2025
Initiation Date
January 3, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
84 units

Product Description

Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D 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-D Generator was commercially approved for distribution in the U.S. on May 13, 2020 via PMA P970003/S231. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

Reason for Recall

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

Distribution Pattern

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.

Code Information

Lot Code: Model No 1000-D UDI-DI: 05425025750528 Lot Numbers/Serial Numbers: 324841 324842 324843 324844 324845 324846 324847 324848 324849 324850 324851 332681 332682 332684 332685 332686 332687 332688 332689 332692 332693 332695 332696 332697 332699 332700 332701 332702 332704 332705 332706 332707 332708 332709 332710 332811 332812 332813 332814 332815 332820 332823 332826 332827 332829 332830 332831 332833 339950 340073 340106 340108 340110 340111 340112 340113 340114 340115 340116 340117 340118 340119 340120 340121 340122 340569 340570 340571 340572 340573 340574 340575 340576 340578 340579 340580 340581 340583 340584 340585 340586 340587 340588 340589

Other recalls by LivaNova USA, Inc.

  • Z-1067-2025 Class II — Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Cat (January 3, 2025)
  • Z-1072-2025 Class II — SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy (December 12, 2024)
  • Z-1073-2025 Class II — SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst S (December 12, 2024)
  • Z-0532-2022 Class II — Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 3 (December 2, 2021)
  • Z-0535-2021 Class II — VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of (November 12, 2020)
  • Z-0462-2021 Class II — VNS Therapy¿ AspireSR¿ Generator (September 28, 2020)
  • Z-2450-2020 Class II — Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Labe (April 24, 2020)
  • Z-2463-2020 Class II — Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Ins (April 24, 2020)
  • Z-2444-2020 Class II — Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Inse (April 24, 2020)
  • Z-2454-2020 Class II — Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert (April 24, 2020)

FDA data resources