Boston Scientific Neuromodulation Corporation - PrecisionTM - Class 2 Recall
Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Neuromodulation - Vectris Trial Screening Lead Kit for Spinal Cord Stimulation - Class 2 Recall
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or fa...
Source: Medical Device Recalls - July 13, 2018 Category: Medical Devices Source Type: alerts

Medtronic Neuromodulation - Vectris Trial Screening Lead Kit for Spinal Cord Stimulation - Class 2 Recall
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Faile...
Source: Medical Device Recalls - July 13, 2018 Category: Medical Devices 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 - RestoreUltra and RestoreSensor - Class 2 Recall
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsu...
Source: Medical Device Recalls - November 1, 2013 Category: Medical Equipment Source Type: alerts