Agency classClass IIOur severity:High FDA (Devices)·Z-0868-2020·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (premature battery depletion) that poses a risk of harm, but the source text does not report any injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

LivaNova USA Inc is recalling 106 Cyberonics VNS Therapy AspireHC Model 105 Generators, serial numbers 35794 through 39731, with expiration dates ranging from February 25, 2017, to May 1, 2017. The devices are vagus nerve stimulators manufactured by Cyberonics, Inc., Houston, TX.

The recall is an expansion of previous actions Z-3019-2017 and Z-3020-2017, initiated to address premature battery depletion caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. The affected devices were distributed nationwide in the United States, including Puerto Rico.

Consumers should contact LivaNova USA Inc for instructions on how to address the defect. The source text does not specify the number of reported injuries or illnesses associated with this recall.

The recalled product

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.
Manufacturer: LivaNova USA Inc
Category: Medical Device — Vagus Nerve Stimulator
Hazard: battery-depletion
electrical-leakage
Affected units: 106

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial numbers 35794
37762
37792
37872
37874
37881
37885
37889
37890
37893
37913
37915
37916
37965
37975
37977
37984
37987
37988
37990

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by LivaNova USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · LivaNova USA Inc

See all →

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VNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
High
VNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure
FDA (Devices) · 2025-02-12
High
Implantable VNS Therapy Generators May Stop Delivering Treatment
FDA (Devices) · 2025-02-05
High
Implantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
FDA (Devices) · 2025-02-05
High
Vagus Nerve Stimulation Therapy Leads Recalled for Tubing Wall Defect
FDA (Devices) · 2022-02-09

Same hazard · battery depletion