Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA product code MHY · Class III (high risk) · Neurology
0510(k) clearances
2PMA approvals
44recalls
Implantimplanted device
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2241-2026 Class II | Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator…A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. | Medtronic Neuromodulation | 05/13/2026Open, Classified |
| Z-2240-2026 Class II | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator…A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. | Medtronic Neuromodulation | 05/13/2026Open, Classified |
| Z-0459-2026 Class II | Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators… | Abbott Medical | 10/06/2025Open, Classified |
| Z-0206-2025 Class II | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to… | Medtronic Neuromodulation | 09/24/2024Open, Classified |
| Z-2432-2024 Class II | Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may… | Abbott Medical | 05/22/2024Open, Classified |
| Z-2431-2024 Class II | Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may… | Abbott Medical | 05/22/2024Open, Classified |
| Z-2430-2024 Class II | Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may… | Abbott Medical | 05/22/2024Open, Classified |
| Z-2429-2024 Class II | Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may… | Abbott Medical | 05/22/2024Open, Classified |
| Z-2265-2024 Class II | Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLYDeep brain stimulation system will first turn off after approximately 50 days after the system is activated… | Abbott Medical | 05/16/2024Open, Classified |
| Z-2427-2024 Class II | A610 Clinician Programmer (CP) Software Application (app) with the following versions:…Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. | Medtronic Neuromodulation | 05/15/2024Open, Classified |
| Z-1408-2023 Class II | Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is…Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been… | Medtronic Neuromodulation | 03/17/2023Open, Classified |
| Z-0121-2024 Class II | SenSight Connector Plug, Model Number B31061.Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due… | Medtronic Neuromodulation | 01/20/2023Open, Classified |
| Z-0217-2024 Class II | LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the… | Medtronic Neuromodulation | 05/27/2022Completed |
| Z-1128-2022 Class II | Percept BrainSense Implantable Neurostimulator (INS), Model B35200The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient… | Medtronic Neuromodulation | 03/30/2022Open, Classified |
| Z-0294-2022 Class II | Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by…The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the… | Medtronic Neuromodulation | 11/04/2021Open, Classified |
| Z-0418-2022 Class II | Model B35200 - Percept PC BrainSense Implantable NeurostimulatorDuring cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become… | Medtronic Neuromodulation | 10/19/2021Open, Classified |
| Z-0201-2022 Class II | Clinician Programmer Application (CPA) model A610 Clinician Software ApplicationA software anomaly may occur with the clinician programmer application. | Medtronic Neuromodulation | 09/23/2021Open, Classified |
| Z-1368-2021 Class II | A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming…There are two issues within this correction action: 1. Cycling Issue: When copying settings from a… | Medtronic Neuromodulation | 03/09/2021Open, Classified |
| Z-0612-2021 Class II | Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a…A software anomaly in the A620 Patient Programmer application was identified that results in failure to… | Medtronic Neuromodulation | 11/19/2020Terminated |
| Z-0593-2019 Class II | St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 -…The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N… | St. Jude Medical, Inc. | 10/11/2018Terminated |
| Z-0023-2018 Class II | Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models…Analysis of the difference between the actual device longevity and the battery indicator status provided by… | St. Jude Medical, Inc. | 09/12/2017Terminated |
| Z-2696-2017 Class II | Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage:…The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar… | St. Jude Medical, Inc. | 06/02/2017Terminated |
| Z-2695-2017 Class II | Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage:…The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar… | St. Jude Medical, Inc. | 06/02/2017Terminated |
| Z-2694-2017 Class II | Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage:…The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar… | St. Jude Medical, Inc. | 06/02/2017Terminated |
| Z-2693-2017 Class II | Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage:…The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar… | St. Jude Medical, Inc. | 06/02/2017Terminated |
| Z-3069-2017 Class II | DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits…Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result… | Medtronic Neuromodulation | 03/17/2017Terminated |
| Z-0700-2017 Class II | Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device…Medtronic has identified an increased number of complaints from customers involving reports of Rechargers… | Medtronic Neuromodulation | 10/03/2016Terminated |
| Z-2645-2016 Class II | DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and…Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001… | Medtronic Neuromodulation | 06/23/2016Terminated |
| Z-2602-2016 Class II | Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) &…Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three… | Medtronic Neuromodulation | 06/10/2016Terminated |
| Z-1617-2015 Class II | Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. SterileMedtronic is providing Important information regarding extension handling during implant procedure after… | Medtronic Neuromodulation | 04/16/2015Terminated |
| Z-2259-2014 Class II | Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use…Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a… | Medtronic Neuromodulation | 07/14/2014Terminated |
| Z-1525-2014 Class II | Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603)…Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that… | Medtronic Neuromodulation | 02/27/2014Terminated |
| Z-0279-2014 Class II | Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602…Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under… | Medtronic Neuromodulation | 09/30/2013Terminated |
| Z-1190-2013 Class I | Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S…There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits.… | Medtronic Neuromodulation | 02/08/2013Terminated |
| Z-0567-2013 Class II | Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086.…Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may… | Medtronic Neuromodulation | 12/03/2012Terminated |
| Z-0894-2013 Class II | Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or…Unintended Fluid ingress into the device header has been shown. | Advanced Neuromodulation Systems Inc. | 03/28/2012Terminated |
| Z-0187-2009 | Medtronic DBS" 3389 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm…Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when… | Medtronic Neuromodulation | 06/14/2008Terminated |
| Z-0186-2009 | Medtronic DBS" 3387 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm…Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when… | Medtronic Neuromodulation | 06/14/2008Terminated |
| Z-0185-2009 | Medtronic DBS" 3389S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of…Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when… | Medtronic Neuromodulation | 06/14/2008Terminated |
| Z-0184-2009 | Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of…Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when… | Medtronic Neuromodulation | 06/14/2008Terminated |
| Z-0694-2008 | Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain…Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit… | Medtronic Neuromodulation | 10/01/2007Terminated |
| Z-0693-2008 | Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx…Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit… | Medtronic Neuromodulation | 10/01/2007Terminated |
| Z-0934-2007 | Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc.…Mislabeling: The inner package labeling incorrectly specified the model number of the lead as 3387-40. The… | Medtronic Neuromodulation | 04/16/2007Terminated |
| Z-0290-2007 | Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428.…A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the… | Medtronic Neurological | 07/19/2006Terminated |