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:

Longevity Estimator Software Error for Subset of Medtronic CIEDs

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

On October 3, 2019, Medtronic began notifying healthcare professionals that a subset of pacemakers and implantable cardioverter defibrillators (including CRT and Micra TPS devices) manufactured between October 2018 and April 2019 may display an inaccurately short estimate of battery longevity. 

Potential Premature Battery Depletion of Certain Medtronic Implantable Pacemakers and CRT-Ps (Azure, Astra, Percepta, Serena and Solara models)

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

May 7, 2019 - The U.S. Food and Drug Administration issued a safety communication to inform patients and health care professionals about the potential for the batteries of certain Medtronic implantable pacemakers to drain more quickly than expected and without warning to patients.

Subset of Medtronic Pacemakers - Potential Circuit Error

Regulatory Agencies
Safety Alerts

On January 17, 2019, Medtronic issued an urgent voluntary recall and distribution suspension affecting a subset of dual-chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019, including the brand names:AdaptaTM, VersaTM, and SensiaTM (USA); ReliaTM, AttestaTM, SpheraTM, and VitatronTM A/E/G/Q series (outside of USA).

Software Update for LifeVest 4000 Wearable Cardioverter Defibrillator

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

January 15, 2019 (Update) - The FDA approved a new software for the  ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed. The potential hazard of the device failing to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service – Message Code 102” was previously described in the January 17, 2018 FDA Safety Communication and an update on July 25, 2018.

FDA Safety Communication- ZOLL LiveVest 4000

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

The FDA approved a new software for the  ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed. The potential hazard of the device failing to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service – Message Code 102” was previously described in the January 17, 2018 FDA Safety Communication and an update on July 25, 2018.

Safety Advisory: Boston Scientific first generation S-ICD system SQ-RX™ Model 1010 Pulse Generators (PG)

Regulatory Agencies
Safety Alerts

November 5, 2018- Boston Scientific released a product advisory related to accelerated battery depletion and a shortened replacement interval observed in some of the first generation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system SQ-RX™ Model 1010 Pulse Generators (PG) (acquired from Cameron Health Incorporated).  There have been no reports of related injury. This safety risk is not applicable to the EMBLEM™ MRI or EMBLEM S-ICD.