The Recall Desk

FDA (Devices) recall action 84029

LivaNova USA Inc recalled 2 products on 2020-02-05

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-02-05
Critical
0
Units
851

Why these products were recalled

This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-02-05

    LivaNova Recalls Cyberonics VNS Therapy AspireHC Model 105 Generators

    LivaNova USA Inc is recalling 106 Cyberonics VNS Therapy AspireHC Model 105 generators due to electrical leakage causing premature battery depletion.

    Product
    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2020-02-05

    LivaNova Recalls Cyberonics VNS Therapy AspireSR Generators for Battery Depletion

    LivaNova is recalling 745 Cyberonics VNS Therapy AspireSR Model 106 generators due to electrical leakage causing premature battery depletion.

    Product
    Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
    Category
    Distribution
    1 state