Cyberonics VNS Therapy AspireSR Generator Recall for Sensing Delays
Cyberonics is recalling 29 Model 106 VNS Therapy AspireSR Generators due to delays in heartbeat sensing and potential decreased battery longevity.
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 (sensing delays) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cyberonics, Inc. is recalling 29 units of the Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106. The recall involves specific serial numbers: 36602, 37019, 39097, 40311, and 40465.
The recall is being conducted because certain Model 106 Pulse Generators demonstrate delays in sensing during the use of the 'Verify Heartbeat Detection' feature. Additionally, these devices exhibit the potential for decreased battery longevity.
The affected units were distributed in the United States to the states of Illinois, North Carolina, Kansas, and Texas, as well as internationally to the United Kingdom. The source text does not specify further instructions for consumers or patients regarding immediate actions to take.
The recalled product
- Product
- Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
- Manufacturer
- Cyberonics, Inc
- Affected units
- 29
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 (5)
- Serial numbers 36602
- 37019
- 39097
- 40311
- 40465
Distribution
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Same hazard · sensing delay
See all →- HighCyberonics Vagus Nerve Stimulator Recall for Sensing Delays
FDA (Devices) · 2015-11-25
Similar recalls
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FDA (Devices) · 2015-11-25
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