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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 (…

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…

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…

During a routine inspection Medtronic noted there was damage to the sterile pouch that contains the In.Pact Admiral Catheters. Upon investigation, there had been a change implemented to one manufacturing line which may cause pouch damage. All batches…

Medtronic has identified eighteen reports where during the advanced evaluation trial period, the percutaneous extension connector has migrated from the future stimulator pocket site along the tunneling pathway. This resulted in difficulty locating the…

Devices built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the…