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Safety Alerts
Boston Scientific ACCOLADE™ Family Pacemakers: Brady SMR6 Software Update and Advisory Population Expansion
Boston Scientific has issued an updated medical device correction for the ACCOLADE™ family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). Brady software maintenance release…
April 23, 2026
Safety Alerts
Device–Device Interaction Between Medtronic Sphere-9™ Ablation Catheter and Biotronik ICD/CRT-D Systems
The Heart Rhythm Society (HRS) is notifying clinicians of a reported device–device interaction between the Medtronic Sphere-9™ ablation catheter and Biotronik implantable cardioverter-defibrillator (ICD) and…
April 16, 2026
Safety Alerts
Update: Boston Scientific ACCOLADE™ Family Pacemakers
Boston Scientific has issued an updated medical device correction for the ACCOLADE™ family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps).
March 31, 2026
Safety Alerts
Update to Boston Scientific RELIANCE G Defibrillation Leads Connected to Non-Boston Scientific ICD Generators
Update from the July 29, 2025 safety alert on Boston Scientific's RELIANCE G defibrillation leads.
February 3, 2026
Safety Alerts
Medtronic Safety Notice: Suspension of Dynamic Sensing Algorithm with Medtronic EV-ICDs
On November 11, 2025, Medtronic released a notice on a potential delay in high voltage (HV) therapy may occur due to a rare sequence of…
November 17, 2025
Safety Alerts
Boston Scientific Accolade Pacemaker Software Update and Revision
On September 29, 2025, Boston Scientific issued an urgent medical device correction to notify clinicians of unintended behaviors associated with the new software released in…
October 10, 2025
Safety Alerts
Update to WATCHMAN Access System (Sheath) Instructions for Use (IFU)
On September 29, 2025, Boston Scientific notified customers of the possibility of air embolism with use of the WATCHMAN access sheaths and has updated their…
October 10, 2025
Safety Alerts
Boston Scientific Advisory Regarding the Potential for Shock Coil Calcification and Reduced Shock Efficacy for RELIANCE G Defibrillation Leads with Gore ePTFE Coated Shock Coils
On July 24, 2025, Boston Scientific began informing clinicians of the potential for gradually rising low-voltage shock impedance (LVSI) associated with shock coil calcification in…
July 29, 2025
Safety Alerts
Boston Scientific Sends Urgent Medical Recall on Limited Number of FARAWAVE™ Pulsed Field Ablation Catheters (US Only)
Boston Scientific is initiating a removal of a limited number of lots (500 total units) of the first generation FARAWAVE™ Pulsed Field Ablation Catheter related…
June 26, 2025
Safety Alerts
Biosense Webster Advisory: Update to the Instructions for Use for VARIPULSE
On February 14, 2025, Biosense Webster, Inc. (BWI) initiated a device correction notification to inform practitioners of updates to the Instructions for Use (IFU) for…
March 26, 2025