Medtronic Neuromodulation

FDA Regulatory Profile

Summary

Total Recalls
95 (14 Class I)
510(k) Clearances
1
Inspections
15
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1043-2026Class IIA71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product numbDecember 3, 2025
Z-0996-2026Class IIRestore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:November 20, 2025
Z-1704-2025Class IIEnhanced Verify Evaluation Handset (CFN HH90130FA)April 3, 2025
Z-1543-2025Class IIStimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 97March 4, 2025
Z-1506-2025Class IIA820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.January 9, 2025
Z-0772-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLININovember 21, 2024
Z-0774-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLININovember 21, 2024
Z-0773-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLININovember 21, 2024
Z-0771-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLININovember 21, 2024
Z-0206-2025Class IIMedtronic Percept RC Implantable Neurostimulators (INS), Model B35300.September 24, 2024
Z-0372-2025Class IIMedtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A RecSeptember 18, 2024
Z-0137-2025Class IISynchroMed II Infusion Pump. Product Number: 8637-20September 11, 2024
Z-0132-2025Class IIVanta Implantable Neurostimulator (INS), Model 977006August 21, 2024
Z-3073-2024Class IIMedtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator KitJune 17, 2024
Z-2427-2024Class IIA610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.xMay 15, 2024
Z-2352-2024Class IIMedtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (May 10, 2024
Z-1691-2024Class IIIntellis AdaptiveStim Product Number 97715, Spinal Cord StimulatorMarch 28, 2024
Z-0780-2024Class IIModel A710 Intellis Clinician Programmer Application, version 2.0.97December 19, 2023
Z-0615-2024Class IIMedtronic SynchroMed II, Model 8637-40, Programmable pumpNovember 13, 2023
Z-0614-2024Class IIMedtronic SynchroMed II, Model 8637-20, Programmable pumpNovember 13, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
DEN210003SureTune4 SoftwareAugust 23, 2021