While it’s classified as a Class I recall, the most serious type of FDA recall, in which use of the device without correction may cause serious injuries or death, it’s a device correction recall rather than a market withdrawal or explant.
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Boston Scientific sent an urgent medical device correction letter to affected customers with an expanded list of 27 affected devices from Accolade pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps) and dual-chamber extended life (DR-EL) devices.
The affected device scope was expanded due to risks of early device replacement when the device enters “Safety Mode.” Safety Mode is caused by high battery impedance, which induces ZIP telemetry disablement in the affected devices, the company said.
Boston Scientific said that devices added in the expanded recall have a 7.6% risk of early device replacement and may not achieve projected longevity. The company’s 2024 recall involved the same battery-related issue.
As of March 18, 2026, Boston Scientific has reported four deaths and 2,557 serious injuries associated with this issue.
Boston Scientific recommended that all Accolade pacemakers, CRT-Ps and DR-EL devices be upgraded with its new Brady SMR6 software prior to continuing use.
Brady SMR6 mitigates the risk of inducing Safety Mode in an ambulatory setting and resolves two “unintended behaviors” introduced with Boston Scientific’s previous software update, Brady SMR5.
These “unintended behaviors” included the risk of test result misinterpretation in the presence of a magnet and prolonged voltage recovery state that could lead to a stuck battery status in some patients, the FDA said.
Boston Scientific is developing a software update and corresponding IFU revision to improve battery impedance test performance and address the longevity impact, the FDA said.
A statement from Boston Scientific
A company spokesperson issued the following statement to MassDevice via email:
“The FDA has classified Boston Scientific’s March 2026 advisory regarding Accolade family pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) per their standard classification process and consistent with the classification of a related 2024 advisory on the devices.
The March 2026 advisory communication announced availability of the SMR6 software, which prevents the device from going into Safety Mode in an ambulatory setting due to a battery issue described in the advisory. The advisory communication provides physicians with details about affected devices, how to upgrade devices with the new software, as well as recommendations for patient care.”
Boston Scientific’s pacemaker recall history
Boston Scientific first warned about the potential need for early device replacement for a subset of its Accolade pacemakers in December 2024 after identifying affected devices with an increased potential to initiate Safety Mode during high-power operations, like telemetry.
Several months later, the FDA issued a Class I recall for the devices, disclosing 832 injuries and two deaths related to the issue.
In September 2025, Boston Scientific launched its Brady SMR5 update, designed to detect high battery impedance and prevent potential initiation of Safety Mode, but identified two “unintended behaviors.” Despite the “unintended behaviors,” the company said the benefits of implementing the software outweigh the risks. Those “unintended behaviors” were said to be mitigated by the latest software update.
Boston Scientific’s pacemaker battery problems have been reportedly ongoing for years, according to a New York Times investigation published on March 19, 2026.
Citing internal company records and government inspection documents that it obtained, the NYT said that battery tests at Boston Scientific’s battery factory near Minneapolis showed batteries unexpectedly failing for years.
In a statement shared with MassDevice in response to the Times’ story, Boston Scientific said:
“Patient safety is our priority. Boston Scientific disagrees with the overall positioning of the article, which omits key context. We stand behind the safety and effectiveness of the company’s devices and quality system and are deeply committed to rigorous device monitoring and reporting. Our pacemakers have a strong safety record and provide life-sustaining therapy to patients around the world.”
