Boston Scientific Accolade Pacemaker Recall Issued After Thousands of Injuries: FDA

Correction addresses ongoing safety concerns tied to device reliability for patients who rely on continuous cardiac therapy from certain Boston Scientific Accolade pacemakers.

Federal safety officials have announced a recall involving certain Boston Scientific Accolade pacemakers and cardiac devices, warning a software defect may impair their ability to deliver life-sustaining therapy.

The U.S. Food and Drug Administration (FDA) announced the Boston Scientific Accolade Pacemaker recall on May 7 after reports of 2,557 serious injuries and four deaths. Regulators have classified the correction as a Class I recall, the agency’s highest-risk category.

The action involves a firmware update to address a known issue that may cause the devices to enter “Safety Mode,” limiting pacing function and potentially preventing delivery of adequate therapy for patients who rely on the products to regulate heart rhythms. 

Pacemaker Risks

Pacemakers are small devices implanted in the chest to regulate abnormal cardiac rhythms by delivering electrical signals that keep the heart beating at a steady rate.

However, malfunctions or design defects can lead to life-threatening complications, with regulators saying the current correction addresses an ongoing safety concern noted in multiple related Accolade recalls.

The FDA indicates the issue has been under ongoing review amid a growing number of adverse event reports that raise concerns about reliability for patients who depend on continuous cardiac therapy.

Accolade Pacemaker Recall

According to federal regulators, a software issue can cause certain Boston Scientific Accolade pacemakers and CRT-Ps to switch into a backup operating state, known as Safety Mode, which is not intended to provide long-term pacing support. This could lead to symptoms such as dizziness, fainting, heart failure complications or other serious cardiac events.

The FDA indicates affected devices were distributed nationwide and are widely used among patients requiring cardiac assistance. Specific product names, model numbers, device listings and UDIs can be found in the FDA’s recall announcement or with the help of the Boston Scientific device lookup tool.

Boston Scientific initiated the current correction to expand prior recalls and address issues introduced by its earlier Brady SMR5 software update, which was intended to reduce Safety Mode risks but led to unintended battery and telemetry problems.

The updated Brady SMR6 firmware is designed to correct incomplete telemetry shutdown, false battery test readings and other performance concerns, while reducing the risk that certain Accolade devices may require premature replacement due to high battery impedance.

Physicians are being urged to prioritize software updates for patients who are most dependent on pacing support, particularly those at higher risk of complications if the device fails to function properly. Regulators are not recommending device removal. Instead, they are advising patients to consult healthcare providers about whether their pacemaker is affected and when the correction should be applied.

Boston Scientific has indicated that the update can be performed during a routine office visit using a programmer, without additional surgery.

For more information, Boston Scientific’s U.S. Technical Services can be contacted at 1-800-227-3422 or by email at tech.services@bsci.com. Healthcare providers and patients can also submit reports of adverse events or device quality issues to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Pacemaker Lawsuits

The recall comes amid growing litigation over alleged pacemaker defects. Late last month, a product liability lawsuit claimed that a defective Medtronic Azure pacemaker failed to properly detect and record dangerous heart rhythm abnormalities, leaving a Pennsylvania woman to experience worsening arrhythmias, repeated complications and emotional distress.

Separately, a Washington woman filed a lawsuit earlier this year claiming a Boston Scientific pacemaker malfunctioned more than a decade after implantation, triggering a life-threatening emergency that required urgent surgery.

Another complaint, brought shortly before that case, alleged a Medtronic Azure dual-chamber pacemaker caused abnormal electrical activity and serious heart rhythm problems for a Connecticut woman, ultimately requiring removal and replacement of the device.

Similar defect allegations have also been raised in spinal cord stimulator lawsuits against Medtronic and Boston Scientific, where plaintiffs claim the devices’ electrical systems led to unexpected shocks, burns and other complications due to design or manufacturing issues.

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