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U.S. Department of Health and Human Services

Class 2 Device Recall A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683

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 Class 2 Device Recall A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683see related information
Date Initiated by FirmDecember 03, 2025
Date PostedJanuary 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1043-2026
Recall Event ID 98097
PMA NumberP840001S594 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
ProductA71200 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).
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.
FEI Number 2182207
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information ContactNaomi Rodiles
763-514-2000
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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 Commerce7123
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LGW
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