46 results
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15ms
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Sources: EU EUDAMED, US FDA
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·December 3, 2022
Model A710 Intellis Clinician Programmer Application, version 2.0.97
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·December 19, 2023
Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·May 16, 2024
Vanta Implantable Neurostimulator (INS), Model 977006
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·August 21, 2024
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·June 21, 2023
Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·July 18, 2023
Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·July 18, 2023
Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·July 18, 2023
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·July 18, 2023
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·October 19, 2023
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·May 16, 2024
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·May 16, 2024
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·December 3, 2022
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
FDA Recall
Open, Classified
·Abbott Medical·Product code LGW·October 6, 2025
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·December 3, 2022
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·March 4, 2025
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·November 20, 2025
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
FDA Recall
Open, Classified
·Boston Scientific Neuromodulation Corporation·Product code LGW·April 29, 2026
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·November 12, 2020
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·July 26, 2022