Boston Scientific Pacemaker Recall – What You Need to Know If You Have an Accolade Device

Boston Scientific Pacemaker Recall – What You Need to Know If You Have an Accolade Device

Boston Scientific’s pacemaker recall has raised serious concerns for thousands of patients across the United States and beyond. The issue centers around a subset of the company’s Accolade family of pacemakers that may suddenly enter a reduced function state known as Safety Mode. This malfunction has been linked to high battery impedance-a battery defect that disrupts the pacemaker’s ability to regulate heart rhythm. The consequences range from dangerous slow heartbeats to complete loss of pacing support.

If you or someone you care for has one of these devices implanted, it’s critical to understand the scope of this recall, what risks may be involved, and what your legal rights are. Over 150,000 devices were distributed worldwide, with nearly 60,000 in the U.S. alone. These pacemakers are typically life-sustaining for individuals with serious heart conditions, making this recall a serious health and safety issue.

Our lawyers are actively reviewing cases for individuals harmed by the defective pacemaker models. If your device has failed or if you’ve been told that you need surgery to replace your pacemaker early, you may be entitled to compensation.

What Is Wrong With the Accolade Pacemaker Devices?

The FDA and Boston Scientific have both confirmed that a manufacturing issue involving the battery’s cathode can lead to high battery impedance. This defect causes the pacemaker to experience sudden voltage drops during certain higher-power operations, such as telemetry or memory checks. If the system resets three times within 48 hours, the device will automatically enter Safety Mode-a failsafe designed to provide limited pacing support.

Unfortunately, Safety Mode is not a viable long-term solution. The pacing is unipolar and fixed at pre-set, non-programmable settings. This may be inadequate or even dangerous for patients who depend on the device to maintain regular cardiac rhythm. There have already been at least two reported deaths and over 800 injuries related to these malfunctions.

The affected devices include models from the ACCOLADE, ESSENTIO, PROPONENT, ALTRUA 2, VALITUDE, and VISIONIST lines, most of which were manufactured before September 2018. Boston Scientific has acknowledged that these units were built with older cathode processing methods that increase the risk of lithium salt buildup-one of the root causes of the defect.

What Happens When a Pacemaker Enters Safety Mode?

When a pacemaker transitions into Safety Mode, its performance drastically changes. Instead of adapting to the patient’s needs, the device defaults to a fixed output (e.g., 72.5 ppm with unipolar pacing). This may not suit all patients, particularly those with advanced heart failure or those dependent on dual-chamber or biventricular pacing.

According to Boston Scientific’s advisory letter, patients experiencing Safety Mode are at risk for serious complications, including fainting, bradycardia, and in some cases, death. The risk is even higher for patients who are not being continuously monitored or who have not undergone recent follow-up evaluations. Remote monitoring is recommended whenever possible to identify early signs of device failure.

One tragic example involved a patient who collapsed at home after their pacemaker entered Safety Mode during a routine remote telemetry session. The device failed to deliver adequate pacing due to the fixed output and high impedance, ultimately leading to a cardiac event. Cases like this underscore the urgency of identifying and replacing affected devices before symptoms emerge.

Who Is at Risk from This Pacemaker Recall?

This recall primarily impacts individuals implanted with Boston Scientific devices built before September 2018. About 13% of pacemakers from this manufacturing period fall into the advisory category, meaning they have an elevated chance of failing due to high battery impedance. Most patients were never informed of these internal battery differences-yet they now face unexpected surgery and health risks.

Patients most at risk include those who are:

• Pacemaker-dependent (unable to maintain heart rhythm without it)
• Using dual-chamber or cardiac resynchronization therapy devices
• Already experiencing device longevity below four years
• Experiencing symptoms such as fainting, fatigue, or dizziness

The issue doesn’t always present symptoms right away. Many failures were first identified during routine in-office checks or remote monitoring. But for others, the malfunction occurred while they were home or unmonitored, which increases the chance of a serious outcome.

Boston Scientific has recommended that health care providers begin evaluating whether early device replacement is needed. For those with devices already operating with limited battery life or who are heavily reliant on pacing, surgery may be advised before any malfunction occurs.

What Should You Do If You Have a Boston Scientific Accolade Pacemaker?

If you’ve received a letter from your doctor or from Boston Scientific, do not ignore it. You should contact your cardiologist immediately and ask if your device is one of the affected models. You can also use Boston Scientific’s online device lookup tool to check if your pacemaker is under recall.

Here’s what else you should do right away:

• Request a device interrogation to confirm current function
• Ask your provider about switching to remote monitoring if you are not already using it
• Discuss your risk of Safety Mode and your pacing dependency
• Plan ahead-if your battery is showing under 4 years remaining, ask whether surgery should be scheduled

Patients should not be left waiting for symptoms to appear. This is a known device malfunction. Whether your health insurance covers it or not, you may have a legal right to pursue financial recovery for the replacement, related complications, and emotional stress involved.

What Legal Rights Do Patients Have in This Recall?

Any patient who has suffered harm due to a defective medical device-especially a life-sustaining one like a pacemaker-may be eligible to file a lawsuit. The Boston Scientific Accolade recall is classified as a Class I recall by the FDA, the most serious type. That means use of the device presents a risk of serious injury or death.

If you or your loved one had to undergo premature surgery to remove an Accolade device, or experienced symptoms tied to Safety Mode failure, you may be entitled to compensation for:

• Medical costs associated with monitoring, surgery, and follow-up
• Lost wages during recovery or due to complications
• Pain and suffering from medical trauma
• Emotional distress and fear related to device failure

In one example, a patient had their pacemaker replaced after multiple unexplained fainting episodes. It was only after the surgery that the cause was linked to Safety Mode. Our firm is investigating similar situations and pursuing claims for victims who were never warned about this dangerous defect.

Speak with our lawyers to evaluate your potential claim and understand how we may be able to help you secure justice.

Which Pacemaker Models Are Affected?

The Boston Scientific Accolade recall includes several models of both standard pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). These were distributed across the U.S., Puerto Rico, U.S. Virgin Islands, and internationally. Devices affected by the recall were all manufactured before September 2018 and include specific model and serial number combinations.

Here are the primary affected product lines:

• ACCOLADE™ DR SL, DR SL MRI, DR EL, DR EL MRI
• PROPONENT™ DR SL, DR VDD SL, DR SL MRI, DR EL, DR EL MRI
• ESSENTIO™ DR SL, SL MRI, EL, EL MRI
• ALTRUA™ 2 DR SL and DR EL
• VALITUDE™ CRT-P EL and EL MRI
• VISIONIST™ CRT-P EL and EL MRI

Each model was assigned a GTIN (Global Trade Item Number) and serial numbers that identify specific units at risk. Boston Scientific has provided a device lookup tool for patients and physicians to confirm whether a specific device is under recall. If you’re unsure, your healthcare provider can help confirm whether your implant falls within the advisory group.

These devices were implanted in over 150,000 people, including nearly 60,000 in the United States alone. Even if your device has not yet failed, if it falls within the advisory group and has four years or less of battery life remaining, your doctor may recommend scheduling a replacement to avoid complications.

Is Surgery Required If You Have a Recalled Device?

Whether surgery is needed depends on your device’s current battery condition, your reliance on pacing, and your individual risk profile. According to Boston Scientific and FDA guidance, not every device needs to be replaced immediately. However, if your device has already entered Safety Mode or is approaching the four-year battery longevity threshold, your doctor may recommend replacement to prevent harm.

There are two categories of patients facing surgical decisions:

• High-risk patients – Those who rely heavily on their pacemaker to maintain heart rhythm. For these individuals, even short disruptions in pacing due to Safety Mode can be life-threatening.
• Lower-risk patients – Individuals who do not depend on the device for every heartbeat may be monitored more closely until battery life becomes a concern.

Importantly, when a pacemaker enters Safety Mode, it switches to unipolar pacing and increases output voltage-draining the battery faster and increasing the risk of failure. Once a device is in Safety Mode, it must be replaced promptly, often on an emergent basis. Do not wait until your device malfunctions. A proactive conversation with your cardiologist is critical to reduce risk.

If your doctor has recommended early surgery due to the recall, and you’re facing additional medical costs or missed work, you should speak with our lawyers. We’re here to help ensure patients are not forced to bear the financial burden of a manufacturer’s error.

Contact Us If You Have a Recalled Pacemaker

Boston Scientific’s recall has caused a great deal of confusion, concern, and disruption for patients who depend on their pacemakers to stay alive. When a life-saving device fails because of a preventable manufacturing flaw, the burden should not fall on the patient to suffer the consequences alone.

If you’ve experienced symptoms, required early device replacement, or were harmed by a malfunctioning pacemaker, you may have a right to recover compensation. Our firm is actively investigating claims on behalf of individuals and families who trusted these devices and are now dealing with the fallout of this recall.

We understand how upsetting and frustrating this situation is. You didn’t ask for this. And you shouldn’t have to fight alone. Our lawyers are ready to answer your questions and guide you through the legal process. Whether it’s surgery expenses, lost time at work, or the emotional toll this situation has caused, we’re here to help.

Contact Alonso Krangle, LLP today at [PHONE] or use the form on this page to get started. Let us fight for the compensation and accountability you deserve.