Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts
Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts
Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts
Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts
Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-RCV-A0 US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts
Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-RCV-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts
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
Boston Scientific Neuromodulation Corporation - None - Class 2 Recall
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact extension kits are part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. They are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts
Boston Scientific Neuromodulation Corporation - LinearTM 34 - Class 2 Recall
The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curved Stylet (1) Stylet Ring with a Curved and a Straight Stylet (4) Suture Sleeves (1) Insertion Needle with Stylet (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labelsleft and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts
Molnlycke Health Care, Inc - EZ Derm Porcine Xenograft - Class 2 Recall
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 ...
Source: Medical Device Recalls - May 1, 2019 Category: Medical Devices Source Type: alerts
Back 2 Basics Direct LLC - Dymaxeon Spine System - Class 2 Recall
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scolios...
Source: Medical Device Recalls - August 22, 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 - 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 - SynchroMed II Implantable Drug Infusion System - Class 2 Recall
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free zi...
Source: Medical Device Recalls - December 20, 2016 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - RestoreSensor and RestoreSensor SureScan - Class 2 Recall
Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 8, 2016 Category: Medical Equipment Source Type: alerts
