Boston Scientific Pacemakers Recalled Over Software Flaw in Safety Architecture (2025)
Boston Scientific recalls 223,163 pacemakers worldwide due to software issues affecting Safety Architecture. The recall covers ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR devices and VISIONIST and VALITUDE CRT-Ps. The defect prevents initiation of Safety Mode when battery impedance is high. Patients should stop using the device and follow manufacturer instructions.