Severity of patient impact from Boston Scientific pacemaker recall: New analysis

Serious complications have been linked to the activation of ‘safety mode’ in pacemaker-dependent patients with recalled Boston Scientific medical device, according to a new analysis.

The authors examined the real-world impact of the recall affecting a subpopulation of Boston Scientific’s ACCOLADE pacemakers and VISIONIST cardiac resynchronisation therapy-pacemakers (CRT-Ps).

Boston Scientific issued the alert in December 2024 warning that some devices could initiate safety mode during telemetry or other high-power operations. The Therapeutic Goods Administration (TGA) and U.S. Food and Drug Administration (FDA) followed with a Class I recall and product safety statement advising patients with affected devices to immediately consult their physician if monitoring indicated the pacemaker had entered safety mode, or if they experienced symptoms such as palpitations or light-headedness. Approximately 2000 devices have been impacted in Australia and 450 in New Zealand.

The company has recommended identifying patients who are at risk of harm from Safety Mode and promptly performing prophylactic generator replacement when pacemaker battery life is less than 4 years for the ACCOLADE and INGENIO family pacemakers and less than 3 years for the INGENIO family CRT-Ps

To quantify the risk, researchers reviewed data focused on patients with pacemakers impacted by the ACCOLADE and earlier INGENIO recalls, covering the period from June 2014 to January 2025.

Among patients whose devices entered safety mode, two-thirds experienced a complication, and nearly one-third (32%) had a major complication. Notably, all safety mode activations occurred in devices with less than four years of battery life remaining.

Pacemaker-dependent patients were significantly more vulnerable – 52% of this group experienced a major complication. These adverse events included death (7%), syncope (28%), falls with trauma (10%), and undocumented oversensing with asystole (38%). Across the broader patient group, the most frequent symptoms were shortness of breath (21%), dizziness (17%), and fatigue (17%).

“This new information should prompt physicians to more strongly recommend prophylactic generator change in pacemaker-dependent patients affected by the INGENIO and ACCOLADE recalls who reach the specified battery longevity criteria,” the authors said.

“Given that most Safety Mode initiations were not identified in a clinical setting, patients with recalled devices should be counselled to seek care immediately if they experience symptoms that could be associated with Safety Mode.”

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