Customer Communications

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Type Product Date Document
Advisory Amplia, Claria, Compia, and Viva CRT-D, and Evera and Visia ICD 2018-Jan Potential Loss of Device Functionality
Advisory Amplia, Claria, Compia, and Viva CRT-D, and Evera and Visia ICD 2018-Mar Potential Loss of Device Functionality Lower Risk Subset
Advisory Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series 2019-Jan Dual Chamber IPG Circuit Error
Advisory LINQ II Insertable Cardiac Monitoring Systems 2021-Jun LINQ II - Brady, Pause and PVC Detections Disabled Following Electrical Reset SN 08-Sep-2021
Advisory Viva™ CRT-D and Evera™ ICD 2016-Aug Potential Rapid Battery Depletion Due To Circuit Component
Advisory Subset of ICDs and CRT-Ds 2021-Feb Potential for Shortened RRT-to-EOS in Subset of ICDs and CRT-Ds
Advisory Percepta MRI, Serena MRI and Solara MRI CRT-P devices 2021-Apr SmartSync Longevity Estimation Software Error
Advisory Azure/Astra DR and SR Pacemakers and Percepta/Serena/Solara CRT-Ps 2021-Apr Unipolar Longevity Estimation Software Error
Advisory Reveal LINQ with TruRhythm Insertable Cardiac Monitoring Systems 2021-Jun Reveal LINQ with TruRhythm - Brady & Pause Detections Disabled Following Electrical Reset
Advisory Claria MRI, Amplia MRI, Compia MRI and CRT-Ds 2020-Mar Potential for Partial Reset During Programmer Interrogation
Performance Note Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ CRT-P 2019-May Performance Note: Potential for no output/no telemetry condition in subset of IPG and CRT-P products due to ceramic capacitor leakage pathway
Advisory InSync® III Model 8042 2015-Nov Potential High Battery Impedance
Advisory Cobalt™ XT, Cobalt and Crome™ ICDs and CRT-Ds 2020-Sep Device Programming Information - Setting VF ATP During Charging Therapy
Advisory Subset of IPG, ICD, CRT-P, CRT-D, and Micra TPS devices - June 2020 2020-Jun CFx Longevity Estimator Software Error - Software Updates Available June 2020
Advisory Azure™ pacemakers, and Percepta™, Serena™, Solara™ CRT-pacemakers 2020-Jun SmartSync Device Manager Telemetry Issue – Software Updates Available June 2020
Advisory Subset of Azure™ S DR pacemakers 2020-Jun Azure S DR Atrial Lead Position Check (ALPC) Incorrectly Enabled – Software Update Available June 2020
Advisory 6930, 6931, 6948, 6949 Sprint Fidelis Defibrillation Leads 2007-Oct Potential Conductor Wire Fracture
Advisory CareLink SmartSync™ Device Manager supporting Cobalt™ and Crome™ ICDs and CRT-Ds 2021-Oct Software Update - SmartSync Error Message on Device Interrogation

 

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