52 results
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28ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·May 15, 2019
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code MHY·September 24, 2024
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code MHY·March 30, 2022
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·December 3, 2022
Model A710 Intellis Clinician Programmer Application, version 2.0.97
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·December 19, 2023
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LKK·May 10, 2024
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code MHY·May 15, 2024
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006).
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LKK·August 9, 2017
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·June 17, 2024
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code MHY·May 13, 2026
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LKK·April 8, 2026
Vanta Implantable Neurostimulator (INS), Model 977006
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·August 21, 2024
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·November 4, 2021
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LKK·November 21, 2024
A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code MHY·March 9, 2021
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·June 21, 2023
Medtronic SynchroMed II, Model 8637-40, Programmable pump
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LKK·November 13, 2023
Clinician Programmer Application (CPA) model A610 Clinician Software Application
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code MHY·September 23, 2021
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code MRU·March 30, 2022
SenSight Connector Plug, Model Number B31061.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code MHY·January 20, 2023