Safety Alerts - LEADconnection
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Safety Alerts

The following content includes advisories, recalls, safety alerts, doctor letters, field action letters, product performance reports and other related information.

Urgent Medical Device Correction: Increased Potential for Reduced Energy or No Energy Delivered During High Voltage Therapy When Programmed AX>B

Advisory letter regarding a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac […]

Limited supply of Model 3300 LATITUDE programmers: Continued use of Model 3120 ZOOM Programmers for Interrogation of Transvenous Defibrillators

Due to the limited supply of Model 2200 LATTITUDE programmers, Boston Scientific recommends continued use of older Model 3120 ZOOM programmers

Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy

Medtronic is recalling Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds)

Update: Unipolar Longevity Estimation Software Error: Azure/Astra DR and SR Pacemakers and Percepta/Serena/Solara CRT-Ps

Software updates are available for Medtronic model 2090, Model 29901 Encore programmers, and SmartSync to correct a programmer display issue.

Update: Potential for Shortened RRT-to-EOS in Subset of ICDs and CRT-Ds

Update on 2021 communication regarding potential for shortened RRT-to-EOS in subset of ICDs and CRT-Ds