Boston Scientific Corporation: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).; Software to enhance Safety Architecture is availabl

What You Should Do

1. Confirm if your pacemaker is affected by checking the model number (e.g., L211 PROPONENT DR SL MRI) and serial number against the provided list; serial numbers include 296409, 658411, 431535, and a large range starting from 100009 through 212228.
2. Contact your healthcare provider or cardiologist immediately to schedule a follow-up appointment for a software update to enhance the device's Safety Architecture.
3. Ensure your physician is aware that a software enhancement is available for the ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE families of devices to prevent unintended Safety Mode initiation.
4. Follow all monitoring and remote check-up instructions provided by your medical team until the software update is successfully applied to your device.
5. For further information or technical questions, contact Boston Scientific Corporation at their Saint Paul, MN facility or call the FDA's medical device hotline at 1-888-463-6332.

Your Remedy Options

Affected Products