The Recall Desk
HighFDA (Devices)·Z-0869-2020·Announced 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.

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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (premature battery depletion in an implanted medical device) where no specific injuries or illnesses are reported in the source text.

Plain-English summary

LivaNova USA Inc is recalling 745 units of the Cyberonics VNS Therapy AspireSR, Model 106 Generator. The devices are identified by serial numbers ranging from 36519 to 43201 and have expiration dates between September 30, 2016, and February 28, 2017. The firm name on the label is CYBERONICS, INC., Houston, TX.

The recall is an expansion of previous recalls Z-3019-2017 and Z-3020-2017. The action is being taken to address premature battery depletion caused by electrical leakage on the circuit board assemblies of the Model 106 generators. This specific recall action occurred in November 2018.

The affected devices were distributed nationwide in the United States, including Puerto Rico. There were no foreign, military, or government consignees. Patients with these devices should contact their healthcare provider or LivaNova for instructions on replacement or repair.

The recalled product

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.
Manufacturer
LivaNova USA Inc
Category
Medical Device — Implantable Neurostimulator
Hazard
Affected units
745

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 36519
  • 36766
  • 36770
  • 36776
  • 36791
  • 36794
  • 36800
  • 36802
  • 36821
  • 36824
  • 36833
  • 36835
  • 36845
  • 36847
  • 36849
  • 36869
  • 36873
  • 36932
  • 36935
  • 36940

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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