A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software
Summary
The FDA issued a Class II for A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2. by Medtronic Neuromodulation. Reason: Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical proced.
Details
Source
Device Recall
External ID
Z-1043-2026
Action Date
2026-01-21
Status
Ongoing
Category
device
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).
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.
Quantity Affected: 7123
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
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-03
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neuromodulation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neuromodulation have FDA actions?
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1043-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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