> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Boston Scientific Device Correction on Certain Pacemakers
- URL: https://www.fdaweb.com/boston-scientific-device-correction-on-certain-pacemakers/
- Published: 2026-05-08T12:00:00.000Z
- Updated: 2026-09-14T13:38:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161116

Boston Scientific has begun a Class 1 recall (device correction) involving certain pacemakers and cardiac resynchronization therapy pacemakers (CRTP) following reports of device malfunctions linked to four deaths and more than 2,500 injuries. The action affects multiple models in the Accolade Family of Implantable Pacemakers and CRTP devices, including Accolade, Essentio, Proponent, Altrua 2, Valitude, and Visionist systems. Rather than removing devices from the market, the correction requires software and firmware upgrades intended to address battery-related telemetry and safety mode problems, according to an [FDA notice](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/pacemaker-correction-boston-scientific-issues-correction-accolade-pacemakers-and-crt-ps?ref=fdaweb.com).

FDA said the issue stems from unintended behaviors associated with a prior software update known as Brady SMR5, which Boston Scientific introduced in 2025 to mitigate risks tied to high battery impedance in affected devices.

According to FDA, the company has now expanded the scope of corrective actions to include all Accolade CRT-P and DR-EL devices because of concerns that high battery impedance could disable ZIP telemetry and lead to premature device replacement or induction of “Safety Mode,” a backup operating state that may affect device performance.

On March 19, the company sent customers an Urgent Medical Device Correction letter instructing providers to upgrade LATITUDE Model 3300 programmers with Brady SMR6 software version 2.05 and use the updated programmers during in-clinic interrogations to install the firmware update on implanted devices.

FDA said Brady SMR6 is intended to fully resolve several problems identified after deployment of Brady SMR5, including incomplete ZIP telemetry disablement in certain scenarios, false-positive battery impedance testing caused by magnets, and a potential prolonged voltage recovery state that could freeze battery diagnostics.

The agency said there remains a residual risk of in-clinic Safety Mode activation during telemetry procedures for some high-risk patients, particularly individuals who are pacemaker-dependent, not enrolled in the Latitude remote monitoring system, and implanted with CRT-P or DR-EL devices with three years or less of battery longevity remaining.

Under the updated recommendations, physicians are being advised to promptly schedule in-person follow-up visits for higher-risk patients who have four years or less of projected battery life and have not yet received previous Brady SMR5 updates. Other patients are advised to continue routine follow-up schedules every 12 months, or every three months once devices reach one-year remaining battery status.