Cyberonics VNS Therapy Programmer Model 3000 Recalled for Parameter Miscalculation
Cyberonics is recalling 252 VNS Therapy Programmer Model 3000 units because certain programming events can miscalculate parameters for implanted generators, potentially causing painful stimulation or lack of therapy.
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. The hazard involves a risk of harm (painful stimulation or lack of therapy) where specific injury reports are not detailed in the source text, fitting the criteria for a High severity score.
Plain-English summary
Cyberonics, Inc. is recalling 252 units of the VNS Therapy Programmer, Model 3000, v1.0 System. The recall is due to a software issue where certain programming events can result in the miscalculation of parameters stored in Models 103, 104, 105, and 106 generators.
These miscalculations can lead to several outcomes depending on the specific generator model. For Model 106 generators, the issue may result in the delivery of more stimulation than intended, causing painful stimulation or other common side effects, or no stimulation at all in the case of device disablement, resulting in no therapy to the patient. For Models 103, 104, 105, and 106, the miscalculations may cause the delivery of less stimulation than intended, preventing therapeutic settings from being achieved within device specification. Additionally, the programming software may display delays or absence of the 75% and 50% battery life indicators for all affected models.
The affected units were distributed in Alabama, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Maine, Missouri, Mississippi, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin. Consumers and healthcare providers should contact Cyberonics for instructions on how to address the issue with the programming software.
The recalled product
- Product
- VNS Therapy Programmer, Model 3000, v1.0 System
- Manufacturer
- Cyberonics, Inc
- Affected units
- 252
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: FMT77F2
- FKR57F2
- FCR77F2
- CJR77F2
- BNT77F2
- BNS77F2
- 7XR77F2
- 7XP57F2
- 79R77F2
- 90S77F2
- 97Q57F2
- 6NT77F2
- 9GP57F2
- 6KQ57F2
- B7Q57F2
- 57P57F2
- 55T77F2
- J6R57F2
- HWR77F2
- 1G7G1F2
Distribution
Related recalls
Same manufacturer · Cyberonics, Inc
See all →- 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 VNS Therapy AspireSR Generator Recall for Sensing Delays
FDA (Devices) · 2016-01-27
- HighCyberonics Recalls VNS Therapy AspireSR Generators Due to Stimulation Failure
FDA (Devices) · 2016-01-27