Boston Scientific Issues New Notice on Accolade Pacemaker Software Update

Boston Scientific has issued a new notice about its Accolade family of pacemakers, following a recall that first began in December 2024. The company continues to work with the FDA to address serious safety issues linked to the devices, including unexpected activation of “Safety Mode.”

At KBD Attorneys, we have been closely tracking these developments. We have previously written about Boston Scientific’s recalls and software updates, and we continue to monitor how these medical device failures impact patients and families.

What Happened in the First Recall

In December 2024, Boston Scientific warned doctors and patients that certain Accolade pacemakers could fail earlier than expected.

The issue was traced to a manufacturing defect. Affected devices showed high battery impedance, which can underpower the system. When this happens, the device can switch into “Safety Mode” during telemetry or other high-power operations.

Safety Mode is meant to protect patients when the device malfunctions, but in this case, it can shut down normal pacemaker functions. For patients who are pacemaker-dependent, this is extremely dangerous.

Unfortunately, Boston Scientific reported at least two deaths in patients implanted with affected devices. These deaths happened when devices initiated Safety Mode in real-world, everyday conditions.

The FDA classified the recall as a Class I recall—the most serious type—because of the risk of injury and death.

Boston Scientific’s First Fix

When the problem came to light, Boston Scientific said it would:

• Improve its manufacturing process for battery cathodes.

• Develop a software update that could detect battery health problems in all Accolade pacemakers.

This was meant to reduce the risk of unexpected Safety Mode events and give doctors and patients more warning before a device failed.

The New Software Update

Now, in September 2025, Boston Scientific has released Model 3869 v2.04 software in the U.S., Australia, and New Zealand.

The new software is designed to do two key things:

1. Detect high battery impedance before it causes failure.

2. Disable ZIP telemetry when battery levels are too high, preventing devices from entering Safety Mode during routine use.

On paper, this is a major improvement. It helps doctors identify pacemakers at risk sooner and prevents sudden failures in normal, everyday situations.

Problems With the Update

However, since the rollout of the update, Boston Scientific has already identified two unintended problems with the software:

1. Incomplete disablement of wandless telemetry. 

   • Even if a device shows high battery impedance, some telemetry functions may not be fully disabled.

   • The device’s new telemetry battery test is designed to continue assessing impedance and shut down telemetry before full failure, but this gap still raises concerns.

2. False positives caused by magnets.

   • The new daily battery test may misread data if the pacemaker is near a magnet.

   • This can trigger a false alert that disables telemetry, even when there is no real problem.

The good news is that these unintended issues do not affect pacing, sensing, or therapy delivery. The core pacemaker functions still work. But telemetry—the way doctors communicate with and monitor the device—can be disrupted.

Should Patients Be Concerned?

Boston Scientific has stressed that the benefits of the update far outweigh the risks. The company does not recommend removing or replacing devices just to avoid these problems.

Instead, the company urges doctors and hospitals to continue installing the software update across all Accolade devices.

Boston Scientific is also actively working on another update to fix the unintended software behaviors.

The FDA says it will keep monitoring the situation with Boston Scientific.

What This Means for Patients and Families

For patients with an Accolade pacemaker, this news may feel alarming. Pacemakers are supposed to give peace of mind, not create new fears.

If you or a loved one has an Accolade device:

• Stay in contact with your doctor. Ask if your device has received the latest software update.

• Report any symptoms immediately. Dizziness, fainting, or irregular heartbeat could signal a device issue.

• Ask about monitoring. Doctors may be able to check battery health more often with the new software.

KBD Attorneys Is Following These Developments

At KBD, we know how devastating medical device failures can be. Patients trust companies like Boston Scientific to provide safe, effective devices. When those devices fail, the results can be catastrophic.

We have written extensively about pacemaker recalls, defibrillator recalls, and other Boston Scientific device issues. We stay on top of these updates so patients and families have the information they need.

If you or a loved one has suffered complications related to a recalled Boston Scientific device, you may have legal options.

How KBD Can Help

• We investigate device failures and determine if they were caused by defects.

• We work with medical experts to understand how recalls affect patients.

• We fight for accountability when companies put profits over patient safety.

If your pacemaker or another heart device has caused harm, contact us today. We are here to help families seek justice and compensation.

Bottom line: Boston Scientific’s new software update for Accolade pacemakers is meant to prevent dangerous device failures. While it helps reduce the risk of Safety Mode events, it also brings new challenges. Patients should work closely with their doctors—and know that legal help is available if device failures cause injury or death.