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.

Use the search engine below to find safety alerts based on the title, year, or device serial number. Filters are not required, but they can improve the search capabilities.

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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.

Safety Advisory : Medtronic Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan Pacemakers

Regulatory Agencies

Safety Alerts

June 22, 2018 - Medtronic released a software update to prevent possible device reset to RV only pacing at 65 bpm for the Percepta family of CRT pacemakers.

Due to a potential timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP) of the Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan, Medtronic has determined that certain devices may revert to RV-only VVI pacing at 65 bpm. Approximately 7,803 devices in the USA are affected.

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

March 19, 2018 - 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.