Cyberonics Recalls VNS Therapy Generators Due to Reduced Longevity
Cyberonics is recalling 1,909 VNS Therapy AspireHC and AspireSR generators because a manufacturing defect may cause them to lose battery life 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 risk of harm (loss of therapy) for an implanted medical device, even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cyberonics, Inc. is recalling 1,909 units of the VNS Therapy AspireHC and AspireSR Generators (Model No. 106). These implanted medical devices are indicated for the adjunctive treatment of epilepsy in adults and adolescents over 12, and for the treatment of chronic or recurrent depression in adults.
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. This defect could lead to the device losing its ability to provide therapy sooner than anticipated.
The affected units were distributed nationwide in the United States, including Puerto Rico, and internationally to 21 countries. Patients with these specific serial numbers should contact their healthcare provider or Cyberonics to discuss the recall and necessary follow-up actions.
The recalled product
- Product
- VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. 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
- Affected units
- 1,909
Distribution
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
See all →- HighCyberonics VNS Therapy Programmer Model 3000 Recalled for Parameter Miscalculation
FDA (Devices) · 2018-06-27
- ModerateCyberonics Recalls Two VNS Therapy Programmer Units Distributed Before Approval
FDA (Devices) · 2018-02-14
- HighCyberonics Recalls VNS Therapy Generators Due to Reduced Longevity
FDA (Devices) · 2017-08-23
- HighCyberonics Recalls VNS Therapy AspireSR Generators Due to Stimulation Failure
FDA (Devices) · 2016-01-27
- HighCyberonics VNS Therapy AspireSR Generator Recall for Sensing Delays
FDA (Devices) · 2016-01-27