Boston Scientific Pacemaker Software Failure Injury and Wrongful Death Lawsuit Lawyers

FDA Confirms Life-Threatening Safety Mode Malfunction Risk in Boston Scientific’s Accolade Family of Pacemakers

The U.S. Food and Drug Administration (FDA) has announced a Class I recall involving more than 1 million Boston Scientific pacemakers, marking the most serious type of recall the agency can issue. This classification means the device defect has the potential to cause serious injury or death.

The affected devices are from the Accolade family of pacemakers, including:

• Accolade
• Proponent
• Essentio
• Altura 2
• Visionist (CRT-P)
• Valitude (CRT-P)

These dual-chamber and cardiac resynchronization therapy pacemakers are commonly implanted in patients with arrhythmias, bradycardia, or heart failure. Unlike many recalls that involve physical removal or return of defective devices, this recall requires a mandatory software update—not removal of the device itself.

Patients, however, must be made aware that failure to receive this software update may result in sudden device failure, posing a significant risk of serious harm.

Background: Safety Mode Malfunction and Battery Issues

The recall stems from long-standing concerns first highlighted in a December 2024 FDA warning, when Boston Scientific reported that certain Accolade-family devices were entering “Safety Mode” unexpectedly.

Safety Mode is designed as a protective function, intended to activate only after three power-on resets within a 48-hour window—typically due to internal battery problems. When activated, it causes the device to shut down normal functionality, often requiring emergency removal and replacement of the pacemaker.

As of the most recent FDA data, the malfunction has been linked to more than 800 patient injuries and at least 2 confirmed deaths.

Patients affected by the issue have reported symptoms such as:

• Irregular heartbeat
• Dizziness or fainting
• Chest discomfort
• Loss of pacemaker pacing
• Cardiac complications requiring hospitalization

FDA Class I Recall Details: Software Update Urged

In September 2025, Boston Scientific released a Model 3869 v2.04 software update designed to prevent Safety Mode activation caused by elevated internal battery impedance. This new recall announcement includes 27 separate Class I recall entries—one for each specific model affected—but all are tied to this common battery software failure.

According to the FDA and Boston Scientific:

• All affected pacemakers must be updated with the Model 3869 v2.04 software.
• Devices that do not receive the update may still enter Safety Mode in ambulatory settings.
• Patients should work with their cardiologists immediately to confirm the update has been applied.

Even though the software is the corrective action, it is crucial to understand that unupdated devices pose a potentially fatal risk, particularly for patients with no backup pacing.

New Software Raises Additional Concerns

Boston Scientific has acknowledged that the Model 3869 v2.04 software, while necessary, is not without complications. Specifically, two new “unintended behaviors” have been reported following the update:

1. Wandless automatic telemetry sessions may fail to stop after detecting high battery impedance.
2. Daily battery tests may record inaccurate measurements when a magnet is nearby, such as during certain procedures or diagnostic tests.

Despite these flaws, Boston Scientific maintains that the benefits of installing the update outweigh the risks. A further revised software update is currently in development to resolve these secondary issues.

The company stated:

“These behaviors do not affect device sensing, therapy delivery or programmed functions. Boston Scientific strongly recommends the continued installation of the software upgrade for all devices while updated software to address these unintended behaviors is developed and approved.”

Patient Safety: What You Need to Do Now

Any individual who has a Boston Scientific pacemaker—especially one from the Accolade family—should immediately:

• Contact their cardiologist or electrophysiologist
• Request confirmation that their device has received the Model 3869 v2.04 software update
• Discuss any symptoms or episodes of lightheadedness, irregular heartbeat, or device alerts
• Monitor any updates from Boston Scientific regarding newer firmware

Do not assume your device is updated automatically—the update must be installed during a clinical appointment or remote session, depending on the device’s capabilities.

Legal Questions and Patient Rights

Pacemaker recalls involving software or battery malfunctions raise serious legal concerns about product safety, device monitoring, and failure to warn. In this case, thousands of patients were implanted with devices that may malfunction and cause injury or death if not updated in time.

Patients and their families may have valid claims if:

• They were injured due to an unexpected pacemaker shutdown.
• Their pacemaker entered Safety Mode and required surgical replacement.
• They suffered a loss of pacing that resulted in hospitalization.
• A loved one passed away and a recalled pacemaker was involved.

Device manufacturers like Boston Scientific have a duty to design, test, and monitor their devices properly. When a failure leads to a Class I recall—especially one involving fatalities—victims may pursue compensation through product liability claims.

FAQs About Boston Scientific Pacemaker Recall Lawsuits

What is the Boston Scientific Accolade pacemaker recall about?
The FDA has issued Class I recalls for more than 1 million pacemakers from Boston Scientific due to a software-related battery malfunction that may trigger Safety Mode unexpectedly. Safety Mode can cause the pacemaker to shut down key functions, which may lead to serious injury or death if the issue is not resolved through a software update.

Which pacemaker models are included in the recall?
The recall includes the Accolade, Proponent, Essentio, Altura 2, Visionist, and Valitude models. All are dual-chamber or CRT pacemakers used in treating cardiac arrhythmias.

Is the device being removed from the body?
No. The FDA and Boston Scientific are not recommending device removal at this time. Instead, a software update must be installed to prevent future malfunctions.

What happens if the software update is not applied?
If the update is not installed, the pacemaker may enter Safety Mode, especially if the internal battery experiences high impedance. Once in Safety Mode, the device may need to be replaced through surgery.

Have patients already been harmed?
Yes. The FDA has confirmed over 800 injuries and two deaths related to the original malfunction. Additional risks may arise if the required update is not applied promptly.

Do I have a case if my pacemaker failed or was replaced?
If you or a loved one experienced harm—such as injury, hospitalization, loss of pacing, or surgical removal—because of a defective Boston Scientific pacemaker, you may have a valid product liability claim.

What compensation could I receive?
Possible compensation includes medical bills, surgical costs, lost income, pain and suffering, and, in cases of death, funeral expenses and wrongful death damages.

Should I talk to a lawyer before the update is applied?
Yes. If you are unsure about your device or have already experienced issues, consulting a lawyer is an important step in protecting your rights, especially before undergoing any procedures or replacements.

If you or someone you love was implanted with a Boston Scientific Accolade family pacemaker and experienced device failure, replacement surgery, or complications from Safety Mode activation, you may be entitled to financial compensation.

CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW

Parker Waichman LLP is a national product liability law firm actively representing individuals harmed by defective or recalled pacemakers. Our attorneys are currently reviewing cases nationwide involving Boston Scientific pacemaker recalls and helping families recover the compensation they deserve.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free consultation. Learn how we can help you file a claim and hold manufacturers accountable for putting your health at risk.