Vanta Clinician Programmer Software Cannot Connect with Multiple Implants
The Vanta Clinician Programmer Application may fail to connect with Vanta neurostimulators when a patient has multiple devices implanted. This prevents programming of pain therapy settings in patients with multiple implants.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported patient injuries or illnesses. The hazard is a communication failure that prevents device programming in the specific case of multiple implants, requiring corrective action but not presenting immediate danger.
Plain-English summary
The Vanta Clinician Programmer Application (Model A71200, Software Version 2.0.2455) is used to program Medtronic Vanta implantable neurostimulators for pain therapy. Approximately 4,386 copies of this application have been downloaded worldwide.
A potential communication issue may prevent the application from connecting with a Vanta Implantable Neurostimulator Model 977006 when a patient has more than one neurostimulator implanted. Unable to establish connection, the application cannot perform its programming function in these cases.
The software has been distributed worldwide, including across all 50 U.S. states, the District of Columbia, Puerto Rico, and numerous countries.
The recalled product
- Product
- Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device
- Affected units
- 4,386
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 (2)
- Model A71200
- Software Version 2.0.2455
Distribution
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