Home / Recalls / LivaNova USA, Inc. / Z-0532-2022

Z-0532-2022 Class II Terminated

Recalled by LivaNova USA, Inc. — Houston, TX

Recall Details

Product Type
Devices
Report Date
February 9, 2022
Initiation Date
December 2, 2021
Termination Date
January 25, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10

Product Description

Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)

Reason for Recall

A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.

Distribution Pattern

US: NE, MO, AR, WV, KS, MA, IN

Code Information

UDI: 05425025750115. Serial Numbers: 119441, 119442, 119443, 119452, 119453, 119454, 119455, 119456, 119457, 119458

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-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-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)