Safety Alerts
Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps
This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as […]
Update on Alert: Defibrillation Lead Issue from Boston Scientific
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall […]
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 Manufactured Between 2002 and 2021
Certain defibrillation leads may put patients at risk due to calcification
Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device Replacement
The devices described in this recall are included in the related Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement – FDA Safety Communication.
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 […]