| 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 |
Cobalt™ XT, Cobalt and Crome™ ICDs and CRT-Ds |
2023-May |
SOFTWARE UPDATE AVAILABLE - Increased Potential for Reduced Energy or No Energy Delivered During HV Therapy When Programmed AX>B (2023) |
| 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 |
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 |
2022-Apr |
Software Update Available to Correct Potential for SmartSync Telemetry Error |
| Advisory |
CareLink™ 2090 Programmer |
2024-Jul |
Potential for Autonomous Cursor Motion |
| Advisory |
Claria, Amplia, Compia, Viva, Brava, Visia AF, Evera, Primo, Mirro ICDs & CRT-Ds |
2023-May |
SOFTWARE UPDATE AVAILABLE - Increased Potential for Reduced Energy or No Energy Delivered During HV Therapy When Programmed AX>B (2023) |
| Advisory |
LINQ II Insertable Cardiac Monitoring Systems |
2024-Jun |
LINQ II ICM Potential for Amplified Noise June 2024 |
| Advisory |
Cobalt™ XT, Cobalt™ and Crome™ ICDs and CRT-Ds |
2022-Jun |
SOFTWARE UPDATE AVAILABLE: Potential for Intermittent-Reduced-Energy Shock Due To Short Circuit Protection Event (2022) As of 02Jul2024 |
