LivaNova VNS Therapy Programmer Recall Due to False Positive Warning Risk
LivaNova is recalling 2,683 VNS Therapy Programmer Model 3000 units because a specific sequence of actions may trigger a false positive warning, potentially leading to unnecessary medical intervention.
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 (unnecessary medical/surgical intervention) due to a device malfunction perception, but no injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
LivaNova USA Inc is recalling 2,683 units of the VNS Therapy Programmer, Model 3000, which is used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. The recall involves software version 1.6 of the device.
The recall is issued because a false positive warning may occur if a VNS Generator is interrogated at 0mA normal output current, then programmed to a non-0mA output current, and subsequently re-interrogated during the session. This sequence can cause users to incorrectly conclude that the device is malfunctioning, which could lead to unnecessary medical or surgical intervention. Users are instructed to lower the output current and widen the pulse width, and to rely only on system diagnostic testing to evaluate output current.
The affected devices were distributed in the United States across numerous states, as well as in Canada and Israel. Healthcare providers and users should verify if they are using the affected model and software version and follow the manufacturer's instructions for corrective action.
The recalled product
- Product
- VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
- Manufacturer
- LivaNova USA Inc
- Affected units
- 2,683
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 (1)
- Model 3000 version 1.6
Distribution
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