News & Perspectives:
Safety Alerts
Jul 24
2025
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
Feb 21
2025
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.
May 1
2023
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 […]
Jul 1
2022
Limited supply of Model 3300 LATITUDE programmers: Continued use of Model 3120 ZOOM Programmers for Interrogation of Transvenous Defibrillators
Due to the limited supply of Model 2200 LATTITUDE programmers, Boston Scientific recommends continued use of older Model 3120 ZOOM programmers
Jun 22
2022
Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy
Medtronic is recalling Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds)