Z-1043-2026 Class II Ongoing
FDA device recall Z-1043-2026 was initiated by Medtronic Neuromodulation on December 3, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 7123.
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2026
- Initiation Date
- December 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7123
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.
Distribution Pattern
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.