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.
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 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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- 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 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
Same hazard · sensing delay
See all →- HighCyberonics VNS Therapy AspireSR Generator Recall for Sensing Delays
FDA (Devices) · 2016-01-27