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Medtronic is notifying customers of a population of LINQ II Insertable Cardiac Monitors (ICM) that underwent a manufacturing process that may allow for moisture to impact electrode performance. This may create the potential for amplified noise and/or…

Medtronic was informed by the contract manufacturer that based on internal investigation they have identified issues with in-process and finished goods endotoxin testing. these issues may have resulted in the release of product with out-of-specification…

Vanta Implantable Neurostimulator (INS) may malfunction after a cardioversion or defrbrillation procedure. The damage/malfunction to the device may no longer allow it to provide therapy or communicate with applications, resulting in a loss of stimulation…

Medtronic has identified a rare potential for reduced or no-energy output during high voltage therapy in Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured with a specific (glassed)…

Loose Temperature Monitoring Adapter (TMA) located on the Affinity Fusion Oxygenator either during pre-procedure perfusion set up or post-procedure when disassembling the perfusion circuit. Recall start date: December 12, 2022

In rare occasions, the Vanta patient programmer app (PP APP) a72200 (all versions) can display a "system update needed, service code 303" during the initial interrogation of a Vanta implantable neurostimulator (INS) model 977006. When this code is…

Connection issue for Vanta pain pc implantable neurostimulators when transplanted in the same patient. "Too many devices" error will appear from Clinician Programmer Application (CPA) when there is more than 1 Vanta ins detected by the clinician…

Notification to inform customers that in rare instances (0.085%) during initial programming, the Vanta CP app will display the error code 1502 message because the Vanta INS reset block id log is full. Once the log is full, all subsequent interrogations…

A system error and termination of program may occur. This may occur when a patient was previously programmed with an A610 dbs clinician programmer application v.2.0.x or later, and later the same device is interrogated with a clinical programmer tablet…

Vanta may not be able to communicate with either the patient programmer or the client programmer system through tel-n communication. Recall start date: June 15, 2022

Medtronic is notifying health care professionals of the potential for reduced shock energy (~79% of programmed energy) during high-voltage (hv) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization…

A software update for Carelink Smartsync™ device managers (Smartsync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDS), and Cardiac Resynchronization Therapy Defibrillators (…

A software update for carelink SmartSync™ device managers (SmartSync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs), and Cardiac Resynchronization Therapy Defibrillators (…

Medtronic has determined that in rare instances (0.044%) the Percept™ PC implantable neurostimulator (INS) model B35200 cannot communicate with the clinician programmer and/or the patient programmer system (HH90 handset and TM91 communicator). In these…

The Reveal Linq Mobile Manager application (MSW002) versions 2.01, 2.02, 2.03.0, and 2.03.01. These versions of LMM have an updated insertion workflow that, if not followed properly, increases the likelihood the patient connector is removed from the…