FDA Gives Boston Scientific Pacemakers and CRT-Ps Highest Recall Warning

The FDA has issued its highest-level recall warning for a Boston Scientific correction affecting ACCOLADE pacemakers and CRT-Ps. The agency said the correction covers ACCOLADE family pacemakers and CRT-P devices, and that the scope was expanded to include CRT-P and DR-EL models.

The FDA said the update is meant to address high battery-impedance risks and Brady SMR5 software behaviors that could disable ZIP telemetry or force early device replacement. As of March 18, 2026, Boston Scientific had reported four deaths and 2,557 serious injuries associated with the issue, according to the FDA.