Z-1043-2026Class II

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

Name: Z-1043-2026 A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200...
Creator: Medtronic Neuromodulation
Published: 2025-12-03
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2025-12-03 / Open, Classified / root cause: software

FDA source

Medtronic Neuromodulation began a recall of 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... on 2025-12-03. FDA classified it as Class II and gives the reason as "Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1043-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-03
Posted: 2026-01-09
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).
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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.
Root cause tag: software
FDA 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 in commerce: 7123
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: version 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1043-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1043-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-09

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)