FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: 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).
- Recall number
- Z-1043-2026
- Recalling firm
- Medtronic Neuromodulation
- 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).
- Status
- Open, Classified
- Initiated
- 2025-12-03
- Posted
- 2026-01-09
- Terminated
- not on file
- Reason
- 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
- Software design
- Action
- 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.
- Quantity
- 7123
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- version 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.
- 510(k) numbers
- not on file
- PMA numbers
- ["P840001S594"]
- Product code
- LGW
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28