Safety Alerts

HRS works closely with our industry partners, domestic and global professional societies, and federal regulatory agencies to communicate safety concerns  with HRS members. 

HRS Safety Alert Response Working Group 

The field of cardiac electrophysiology (EP) relies on technological advances that improve patients' lives. However, there are also EP device software/hardware updates, safety notices, advisories, and recalls that occur periodically.

Therefore, in 2014, HRS created the Safety Alert Response Working Group, which convenes on an as-needed basis, to review any EP device -related advisory issue or safety notification that may affect HRS members and their patients.

The goals of the Working Group are to review these advisory or safety issues and to communicate with HRS members in a timely manner to enhance awareness of these issues in the EP community.

HRS will continue to work closely with our industry partners, domestic and global professional societies, and federal regulatory agencies in a collaborative, interactive manner to provide our membership with clear, accurate information concerning EP device advisories and other safety issues. The Safety Alert Response Working Group aims to provide concise, useful information (and recommendations when appropriate) without excessively burdening clinicians as these safety issues arise

Reporting Adverse Events

The Heart Rhythm Society encourages healthcare professionals and patients to report adverse events or product problems to FDA through MedWatch, the FDASafety Information and Adverse Event Reporting Program. There are several options for reporting:

Abbott Advisory : Battery Performance and Firmware Update - April 2018

Regulatory Agencies
Safety Alerts
U.S. Food and Drug Administration (FDA)

April 18, 2018-The US Food and Drug Administration (FDA) issued a Medical Device Safety Communication announcing a firmware update that addresses 2 previously reported safety concerns. The update includes a battery performance alert and improved cybersecurity for certain high voltage implantable cardiac devices (ICDs and CRT-Ds). Abbott has sent a medical device advisory to physicians making them aware of the firmware update.

Medtronic Extends Voluntary Recall to Include 752 ICDs and CRT-D Units Due to Lack of Electrical Shock Delivery

Regulatory Agencies
Safety Alerts

On March 16, 2018- Medtronic announced a voluntary recall affecting 752 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs). This notification extends the Food and Drug Administration (FDA) recall on February 26, 2018 of 48 Medtronic devices that were identified to have a defect in the manufacturing process that could lead to an out-of-specification internal gas environment.