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Medtronic Neuromodulation Recalls

63 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Medtronic Neuromodulation.

63Total Recalls
10Critical
2.6MUnits Affected
Dec 3, 2025Most Recent
All Recalls

Every Medtronic Neuromodulation Recall

Sorted by most recent. Click any recall for full details.

63 recalls
High RiskFDA
Medtronic Neuromodulation
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usa...
Medical Implants·13,784 affected·Apr 4, 2014
High RiskFDA
Medtronic Neuromodulation
Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Ne...
Medical Devices·170,286 affected·Feb 27, 2014
High RiskFDA
Medtronic Neuromodulation
Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), Restor...
Medical Devices·170,286 affected·Feb 27, 2014
High RiskFDA
Medtronic Neuromodulation
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulati...
Medical Implants·64,163 affected·Sep 30, 2013
High RiskFDA
Medtronic Neuromodulation
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
Medical Devices·64,163 affected·Sep 30, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment,...
Medical Implants·115,722 affected·Jun 3, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, cat...
Medical Implants·115,722 affected·Jun 3, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxi...
Medical Implants·261,109 affected·Jun 3, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump conn...
Medical Implants·115,722 affected·Jun 3, 2013
High RiskFDA
Medtronic Neuromodulation
Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obst...
Medical Devices·848 affected·Feb 27, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia The...
Medical Devices·30,000 affected·Feb 8, 2013
CriticalFDA
Medtronic Neuromodulation
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product U...
Medical Devices·30,000 affected·Feb 8, 2013
High RiskFDA
Medtronic Neuromodulation
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba...
Medical Devices·140 affected·Dec 3, 2012
CriticalFDA
Medtronic Neuromodulation
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump i...
Medical Implants·174,700 affected·Nov 9, 2012
CriticalFDA
Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene ox...
Medical Implants·174,700 affected·Nov 9, 2012