PlainRecalls

Medtronic Neuromodulation

64 recalls on record · Latest: Jan 21, 2026

FDA Devices Moderate May 7, 2014

Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulato…

FDA Devices Moderate May 7, 2014

Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR Sure…

FDA Devices Moderate Nov 20, 2013

Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.

FDA Devices Moderate Nov 6, 2013

Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Med…

FDA Devices Critical Jul 3, 2013

Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge …

FDA Devices Critical Jul 3, 2013

Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, conne…

FDA Devices Critical Jul 3, 2013

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump…

FDA Devices Critical Jul 3, 2013

Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spina…

FDA Devices Critical May 8, 2013

Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is …

FDA Devices Critical May 8, 2013

Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The…

FDA Devices Moderate Apr 10, 2013

Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction seco…

FDA Devices Moderate Dec 26, 2012

Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Ric…

FDA Devices Critical Dec 19, 2012

SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an…

FDA Devices Critical Dec 19, 2012

Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pum…