Home / Recalls / LivaNova USA Inc / Z-1118-2020

Z-1118-2020 Class II Terminated

Recalled by LivaNova USA Inc — Houston, TX

Recall Details

Product Type
Devices
Report Date
February 19, 2020
Initiation Date
August 13, 2019
Termination Date
May 18, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 generators

Product Description

VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)

Reason for Recall

Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.

Distribution Pattern

US: FL, GA, KS, MO, and UT. No OUS distribution

Code Information

Model Serial No. UDI Model 1000 204460 01054250257504051119080317201205212044609910-0011-6102 Model 1000 183960 01054250257504051119080217200912211839609910-0011-6102 Model 1000 194980 01054250257504051119080217201030211949809910-0011-6102 Model 1000 204700 01054250257504051119080217201205212047009910-0011-6102 Model 1000 206720 01054250257504051119080317201219212067209910-0011-6102 Model 1000 213290 01054250257504051119080517210108212132909910-0011-6102

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-1068-2025 Class II — Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D (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-2443-2020 Class II — Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Inser (April 24, 2020)
  • Z-2449-2020 Class II — Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert (April 24, 2020)
  • Z-2446-2020 Class II — Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert L (April 24, 2020)