—#217610

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).

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P840001S594
Affected lot / code info: version 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

On December 3, 2025 the firm distributed Urgent Medical Device Safety Notification letters to affected consignees. Customers were instructed to download and install A81200 CP App v2.0.2684 or any later version.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: Worldwide - US Nationwide distribution.

Timeline

Recall initiated: 2025-12-03
Posted by FDA: 2026-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217610. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.