The Recall Desk
HighFDA (Devices)·Z-3019-2017·Announced 2017-08-23

Cyberonics Recalls VNS Therapy Generators Due to Reduced Longevity

Cyberonics is recalling 396 VNS Therapy AspireHC and AspireSR generators because a manufacturing defect may cause the devices to lose power faster than expected.

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 medical device that may fail to provide the intended therapeutic benefit (reduced longevity), which fits the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Cyberonics, Inc. is recalling 396 units of the VNS Therapy AspireHC and AspireSR Generators (Model No. 105). The recall was initiated because the manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.

The affected devices were distributed worldwide, including nationwide in the United States, Puerto Rico, and various international locations. The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. It is also indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who have not had an adequate response to four or more adequate antidepressant treatments.

Patients with these specific serial numbers should contact their healthcare provider or Cyberonics for further instructions regarding the recall and potential replacement of the device.

The recalled product

Product
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults an
Manufacturer
Cyberonics, Inc
Category
Medical Device — Implantable Neurostimulator
Hazard
Affected units
396

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 No. (Exp Date): 35283 (01/22/2017)
  • 35339 (01/22/2017)
  • 35354 (01/22/2017)
  • 35355 (01/22/2017)
  • 35458 (01/22/2017)
  • 35474 (01/22/2017)
  • 35487 (01/22/2017)
  • 35492 (01/22/2017)
  • 35561 (01/22/2017)
  • 35565 (01/22/2017)
  • 35568 (01/22/2017)
  • 35603 (01/22/2017)
  • 35614 (02/05/2017)
  • 35615 (02/05/2017)
  • 35617 (02/05/2017)
  • 35618 (02/05/2017)
  • 35624 (02/05/2017)
  • 35625 (02/05/2017)
  • 35634 (02/05/2017)
  • 35705 (02/05/2017)

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Cyberonics, 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 · Cyberonics, Inc

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Same hazard · device failure

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