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    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PNJ·November 21, 2024

    Merlin.net model MN5000 Software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022

    Merlin 2 PCS MER37000 programmer Model MER3400 software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022

    Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PNJ·May 12, 2026

    Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile

    FDA Recall
    Open, Classified ·Abbott Medical·Product code NPT·October 17, 2024

    Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile

    FDA Recall
    Open, Classified ·Abbott Medical·Product code NPT·October 17, 2024

    Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile

    FDA Recall
    Open, Classified ·Abbott Medical·Product code NPT·October 17, 2024

    Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile

    FDA Recall
    Open, Classified ·Abbott Medical·Product code NPT·October 17, 2024

    Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD REF CDDRA600Q Entrant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA300Q Entrant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LWS·August 16, 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

    Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400

    FDA Recall
    Open, Classified ·Abbott Medical·Product code MHY·October 6, 2025

    Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code MHY·May 22, 2024

    Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PMP·May 16, 2024

    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

    Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·October 6, 2025