FDA Device Intelligence
HomeDevice types › MHY

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA product code MHY · Class 3 · Unknown

340
Registered devices
52,953
Adverse events
46
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-05-13Medtronic NeuromodulationA limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
2026-05-13Medtronic NeuromodulationA limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
2025-10-06Abbott MedicalThere is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation
2024-09-24Medtronic NeuromodulationA limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Applicati
2024-05-22Abbott MedicalTheir is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling po
2024-05-22Abbott MedicalTheir is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling po
2024-05-22Abbott MedicalTheir is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling po
2024-05-22Abbott MedicalTheir is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling po
2024-05-16Abbott MedicalDeep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approx
2024-05-15Medtronic NeuromodulationPatients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.