Vanta Clinician Programmer Application error prevents programming of implanted neurostimulators
The Vanta Clinician Programmer Application v2.0.2455 may display Error Code 1502, preventing users from programming Vanta implantable neurostimulators. The issue affects 2,920 downloaded software applications distributed worldwide.
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: This is an FDA Class II medical device software recall. While no illnesses or injuries have been reported, the error prevents clinicians from programming pain therapy devices, constituting a risk of harm to patients who depend on these devices for pain management.
Plain-English summary
Medtronic Neuromodulation has issued a recall for the Vanta Clinician Programmer Application, Model A71200, Software Version 2.0.2455. The application is used by clinicians to program Medtronic Model 977006 Vanta implantable neurostimulators, which are medical devices designed for pain therapy treatment.
The recall addresses a potential software error in this version of the application. The error causes an unexpected Error Code 1502 message to display, preventing users from performing programming operations on the Vanta implantable neurostimulator.
Approximately 2,920 copies of the affected software version have been downloaded. The product has been distributed worldwide, including throughout the United States and to multiple countries including Canada, the United Kingdom, and several European nations.
This is a Class II recall issued by the U.S. Food and Drug Administration.
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
- Affected units
- 2,920
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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