FDA designates Class 1 recall for pacemaker

Editor’s Note

The US Food and Drug Administration (FDA) has designated Boston Scientific Corporation’s recall of Accolade Pacemaker devices a Class 1, the most severe category indicating serious risk of injury or death.

According to the agency’s February 21 announcement, the recall was motivated by a manufacturing issue that could cause the device to enter safety mode. Intended to activate only during critical component failures, safety mode cannot be reversed and may result in serious injury or death due to interruption of pacing.

Affected devices include ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers as well as VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). The full FDA announcement provides a list of specific models, including identification numbers.

According to the announcement, users are advised to replace devices entering safety mode immediately for patients at high risk of harm. Other instructions include avoiding reliance on battery life estimates in safety mode, conducting system follow-ups, and more. The announcement also offers instructions for patient monitoring and other actions while FDA’s evaluation is ongoing.