Cyberonics Vagus Nerve Stimulator Recall for Sensing Delays
Cyberonics is recalling 27 Model 106 Vagus Nerve Stimulator generators due to delays in heartbeat detection 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 high-risk medical device with a functional defect (sensing delay) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cyberonics, Inc. is recalling 27 units of the Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106. The recall was initiated because certain units demonstrate delays in sensing during the use of the 'Verify Heartbeat Detection' feature and exhibit a potential for decreased battery longevity.
The affected devices were distributed in the United States to the states of Oregon, New York, Georgia, Pennsylvania, California, North Carolina, Kansas, Florida, Kentucky, Michigan, Texas, Illinois, Ohio, Indiana, Utah, Colorado, and West Virginia. The specific serial numbers for the recalled units are: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, and 42780.
Consumers and healthcare providers should check the serial number of their device against the list provided. If the device is affected, they should contact Cyberonics, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
- Manufacturer
- Cyberonics, Inc
- Affected units
- 27
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: 37719
- 37899
- 38123
- 38414
- 38428
- 39385
- 39531
- 39607
- 39801
- 39821
- 40037
- 40048
- 40249
- 40251
- 40271
- 40354
- 40428
- 40488
- 40526
- 40603
Distribution
Related recalls
Same manufacturer · Cyberonics, Inc
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- HighCyberonics Recalls VNS Therapy AspireSR Generators Due to Stimulation Failure
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Same hazard · sensing delay
See all →- HighCyberonics VNS Therapy AspireSR Generator Recall for Sensing Delays
FDA (Devices) · 2016-01-27
Similar recalls
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- HighCyberonics Recalls VNS Therapy AspireSR Generators Due to Stimulation Failure
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- HighLivaNova Recalls Cyberonics VNS Therapy AspireSR Generators for Battery Depletion
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- HighLivaNova Recalls Cyberonics VNS Therapy AspireHC Model 105 Generators
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- HighCyberonics Recalls VNS Therapy Generators Due to Reduced Longevity
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- LowCyberonics VNS Therapy Generator Recalled for Incorrect Serial Number Labeling
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