Home / Recalls / LivaNova USA Inc / Z-0535-2021

Z-0535-2021 Class II Terminated

Recalled by LivaNova USA Inc — Houston, TX

Recall Details

Product Type
Devices
Report Date
December 16, 2020
Initiation Date
November 12, 2020
Termination Date
January 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 generators

Product Description

VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.

Reason for Recall

During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.

Distribution Pattern

International distribution in the countries of Austria and United Kingdom.

Code Information

Model Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348

Other recalls by LivaNova USA Inc

  • Z-1068-2025 Class II — Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D (January 3, 2025)
  • 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-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-2452-2020 Class II — Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert (April 24, 2020)
  • Z-2457-2020 Class II — Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert La (April 24, 2020)