Medtronic Neuromodulation - DBS Lead Depth Stop - Class 2 Recall
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2017 Category: Medical Devices Source Type: alerts
Medtronic Neuromodulation - DBS Pocket Adaptor - Class 2 Recall
DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2016 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - Medtronic DBS Extension Kit for - Class 2 Recall
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2015 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - Medtronic, External neurostimulator - Class 2 Recall
Medtronic, External neurostimulator, ENS (37021) & ENS (37022). All Restore, PrimeAdvanced¿ and Itrel 4 devices are used for Spinal Cord Stimulation. All Activa devices are used for Deep Brain Stimulation. Restore¿ (Model 37711), the first released affected product was released to the market in April, 2005. There are a total of 19 affected device models, including the external neurostimulators which are associated with software application run on the NVision¿ Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - Activa PC, Activa RC, Active SC - Class 2 Recall
Medtronic, Activa¿¿ RC (37612), Activa¿¿ PC (37601), Activa¿¿ SC (37602), Activa¿¿ SC (37603),Activa¿¿ PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for mouvement disorders. All Restore, PrimeAdvanced¿ and Itrel 4 devices are used for Spinal Cord Stimulation. All Activa devices are used for Deep Brain Stimulation. Restore¿ (Model 37711), the first released affected product was released to the market in April, 2005. There are a total of 19 affected device models, including the external neurostimulators which are associa...
Source: Medical Device Recalls - April 30, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - RestoreUltra and RestoreSensor - Class 2 Recall
Medtronic, Restore¿ (37711), RestoreADVANCED¿ (37713), RestoreADVANCED¿ SureScan¿ MRI (97713), RestoreSENSOR¿ (37714), RestoreSENSOR¿ SureScan¿ MRI (97714),PrimeAdvanced¿ SureScan MRI, (97702),RestoreULTRA¿ (37712),RestoreULTRA¿ SureScan¿ MRI (97712) Itrel¿4 (37703),Itrel¿4 (37704),RestorePrime¿ (37701),PrimeAdvanced¿ (37702), Spinal cord Stimulation for chronic pain. All Restore, PrimeAdvanced¿ and Itrel 4 devices are used for Spinal Cord Stimulation. All Activa devices are used for Deep Brain Stimulation. Restore¿ (Model 37711),...
Source: Medical Device Recalls - April 30, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - Activa PC, Activa RC, Activa SC - Class 2 Recall
Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - Activa PC, Activa RC, Active SC - Class 2 Recall
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 15, 2013 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - Activa PC and Activa RC - Class 2 Recall
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation o...
Source: Medical Device Recalls - November 1, 2013 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - Deep Brain Stimulation Lead Kit - Class 1 Recall
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia, Essential Tremor (ET), Obsessive-Compulsive Disorder (OCD), Parkinson s Disease (PD), and epilepsy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 2, 2013 Category: Medical Equipment Source Type: alerts
