A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product n...

FDA Recall #Z-1043-2026 — Class II — December 3, 2025

Recall #Z-1043-2026 Date: December 3, 2025 Classification: Class II Status: Ongoing

Product Description

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).

Reason for Recall

Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

Recalling Firm

Medtronic Neuromodulation — Minneapolis, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7123

Distribution

Worldwide - US Nationwide distribution.

Code Information

version 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated