The Recall Desk
HighFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · LivaNova USA Inc

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Same hazard · battery depletion

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