| Advisory |
Cobalt™ XT, Cobalt and Crome™ ICDs and CRT-Ds |
2023-May |
Increased Potential for Reduced Energy or No Energy Delivered During HV Therapy When Programmed AX>B (2023) |
| Advisory |
Claria, Amplia, Compia, Viva, Brava, Visia AF, Evera, Primo, Mirro ICDs & CRT-Ds |
2023-May |
Increased Potential for Reduced Energy or No Energy Delivered During HV Therapy When Programmed AX>B (2023) |
| Education Brief |
Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ CRT-P |
2023-Apr |
Product Education Brief: Alert Threshold for Lead Impedances |
| Advisory |
LINQ II Insertable Cardiac Monitoring Systems |
2021-Jun |
LINQ II - Brady, Pause and PVC Detections Disabled Following Electrical Reset SN 21-Mar-2022 |
| Advisory |
Azure™ pacemakers, and Percepta™, Serena™, Solara™ CRT-pacemakers |
2020-Jun |
SmartSync Device Manager Telemetry Issue – Software Updates Available June 2020 |
| Advisory |
6930, 6931, 6948, 6949 Sprint Fidelis Defibrillation Leads |
2007-Oct |
Potential Conductor Wire Fracture |
| Education Brief |
Micra TPS devices |
2021-Nov |
Procedure Education Brief: Micra TPS Implant |
| Advisory |
LINQ II Insertable Cardiac Monitoring Systems |
2022-Jan |
A Subset of LINQ II ICMs Susceptible to Moisture Ingress |
| Advisory |
Amplia, Claria, Compia, and Viva CRT-D, and Evera and Visia ICD |
2018-Mar |
Potential Loss of Device Functionality Lower Risk Subset |
| Advisory |
Cobalt™ XT, Cobalt™ and Crome™ ICDs and CRT-Ds |
2022-Jun |
Potential for Intermittent-Reduced-Energy Shock Due To Short Circuit Protection Event (2022) |
| Advisory |
CareLink SmartSync™ Device Manager supporting Cobalt™ and Crome™ ICDs and CRT-Ds |
2022-Apr |
Software Update Available to Correct Potential for SmartSync Telemetry Error |
| Advisory |
CareLink SmartSync™ Device Manager supporting Cobalt™ and Crome™ ICDs and CRT-Ds |
2021-Oct |
Software Update - SmartSync Error Message on Device Interrogation |
| Advisory |
Subset of ICDs and CRT-Ds |
2021-Feb |
Potential for Shortened RRT-to-EOS in Subset of ICDs and CRT-Ds |
| 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 |
| 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 |
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 |
