Neurostimulator clinician programmer app recalled over faults during device use
Medtronic is recalling 7,123 units of the Vanta Clinician Programmer Application after complaints that it does not function as intended during use.
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: Scored 2 because the record's stated consequence is a prolonged or postponed procedure rather than patient harm, and no injuries are reported.
Plain-English summary
The A71200 Vanta Clinician Programmer Application (CP App), versions 2.0.2465 and 2.0.2683, product number A71200, is being recalled by Medtronic Neuromodulation. The record states the software is deployed and operated on Samsung tablets (CFN CT900).
The reason given in the enforcement record is complaints received that the Vanta A71200 CP App does not function as intended during use, and that there is a potential for a prolonged or postponed surgical procedure.
The record lists 7,123 units under UDI-DI (GTIN) 00763000520083 and states that the affected product is the software and that implanted Vanta neurostimulator devices are not affected. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is a prolonged or postponed procedure, and no injuries are reported. Clinicians should follow Medtronic's instructions.
The recalled product
- Product
- A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 7,123
Distribution
Distributed nationwide across the United States.
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