Accolade Pacemaker Recall Lawsuits: Boston Scientific Defective Pacemakers Lead to Injuries and Death

Defective Boston Scientific Pacemakers Have Caused Over 800 Serious Injuries and Multiple Deaths, Leading to a Massive Recall and Personal Injury Lawsuits. Continue Reading to Find Out If You’re Eligible to File a Boston Scientific Accolade Pacemaker Claim.

• About 203,000 devices from the Accolade family of pacemakers built before September 2018 have been issued a Class I recall, the highest level possible.
• The affected pacemakers include Accolade and multiple others made by Boston Scientific.
• The FDA recommends that patients work with their doctors to monitor their devices and to determine their course of action.
• The malfunction involves the device’s battery failing, preventing the pacemaker from working effectively.

Boston Scientific, a global manufacturer of medical devices, is in the hot seat after the FDA issued its most serious recall (Class I recall) for hundreds of thousands of its pacemakers. At the center of it all is the Accolade family of pacemakers, which is by far their most popular cardiac device. These life-sustaining dual-chamber pacemakers have been tied to a growing list of serious health issues, emergency surgeries, and tragically, multiple deaths.

Roughly 203,000 of these pacemakers, all built before September 2018, are affected globally. That’s not a small mistake. That’s a global failure that’s putting thousands of lives at risk.

If you or someone you love had one of these devices implanted and things went wrong, or even if you’re just now learning about it, here’s everything you need to know about what’s happening, why it matters, and how you can fight back.

Read the FDA Recall

Why Is the Boston Scientific Accolade Pacemaker Being Recalled?

The Pacemaker Recall Problem: Battery Defects, High Internal Cell Impedance (HICI), and Safety Mode

In December 2024, Boston Scientific quietly issued an urgent advisory to physicians about a manufacturing defect in their pacemakers’ batteries that causes the device to slip into something called Safety Mode.

The malfunction in the Accolade pacemaker and other types made by Boston Scientific was due to a manufacturing defect in the battery, which could lead to something known as “high internal cell impedance” or HICI. Basically, HICI is a decrease in power from the battery, which causes the device to slip into “Safety Mode”.

Safety Mode is meant to be a backup plan if something goes wrong with the pacemaker. However, because of the HICI issue described above, or even routine checks while the pacemaker is being monitored, the device can unintentionally reset. If this reset occurs three times within 48 hours, which often occurs because of these malfunctions, the pacemaker can get stuck in Safety Mode. 

If this happens, the pacemaker stops working properly. Instead of providing the right pacing, which is a critical feature for some patients, it will basically factory reset to its default settings.

Instead of the personalized settings the pacemaker was set to for your specific heart condition, you get default factory settings that may not be able to keep your heart stable, especially if you are pacemaker-dependent (see “How does a pacemaker work” for more information). 

If your heart relies on this device, this malfunction can be catastrophic, leading to insufficient pacing, a return of severe bradycardia (a heart rate that is slower than usual), or other life-threatening arrhythmias (irregular heart rhythms).

Unfortunately,  the Accolade pacemaker and other pacemakers made by Boston Scientific are failing on both of these important tasks. Both Continuously Active Pacemakers and On-Demand Pacemakers have been malfunctioning. 

"The anxiety is the worst part, just waiting and wondering if today's the day it fails." -Reddit User

Some Patients Are At An Even Higher Risk of Injury or Death from Accolade Pacemakers

Some patients with defective devices face even higher risks if they’ve had previous surgeries or have a pacemaker that is connected to multiple parts of the heart (aka multiple leads).

These patients are more likely to experience complications and often need urgent intervention.

Concerns about interference from magnets are always present for anyone with a pacemaker. However, the defects in the recalled Boston Scientific pacemakers present an even more significant and immediate threat.

How many people have been injured or died due to the Accolade or Boston Scientific Pacemakers?

So far, the FDA has confirmed that these devices have already injured 832 people and at least two people have died.

Many of the issues started during introductory monitoring sessions, either in-office or through remote systems like the LATITUDE Communicator.

Boston Scientific Pacemakers Impacted by the Recall

According to the FDA and Boston Scientific’s own statement, the following pacemakers are part of this important Class One recall:

Boston Scientific Pacemaker Products:

• ACCOLADE
• PROPONENT
• ESSENTIO
• ALTRUA 2 Dual Chamber Standard Life
• ALTRUA 2 Dual Chamber Extended Life
• VISIONIST CRT-Ps
• VALITUDE CRT-Ps

Boston Scientific Pacemaker Models:

• ACCOLADE DR SL (Model L301)
• ACCOLADE DR SL MRI (Model L311)
• ACCOLADE DR EL (Model L321)
• ACCOLADE DR EL MRI (Model L331)

Contact your cardiologist or cardiac care provider immediately if you have any concerns about your specific Boston Scientific pacemaker.

This article is not intended to be taken as medical advice, so please contact your doctor right away if you think any of this information affects you!

You can also check if your device is part of the recall by using Boston Scientific’s device lookup tool.

How Does A Pacemaker Work?

• A pacemaker is a small, battery-operated device that’s implanted in the chest to help regulate a person’s heartbeat. It sends electrical signals to the heart to ensure it beats at a steady, proper rate. Pacemakers are most commonly implanted when the heart’s natural pacemaker (known as the sinoatrial node) is not working properly. 
• Pacemakers are about the size of a half-dollar or book of matches, however they can be a little larger or much smaller, depending on the type. The devices in question are the larger versions.
• Pacemakers work by sending small electrical pulses to the heart muscle, causing it to contract and pump blood. These electrical signals are similar to those your body would naturally produce to make a muscle contraction.
• Some pacemakers are literally on all the time to keep the heart’s rhythm at thcorrectht rate. People with these pacemakers are known as pacemaker-dependent. Other pacemakers only turn on when they detect a problem with the heartbeat and need to intervene.

Continuously Active Pacemakers:

• Some pacemakers are programmed to operate continuously, delivering electrical impulses to maintain a consistent heart rate.
• These pacemakers are used when the heart’s natural pacemaker is not functioning properly.
• They ensure that the heart beats at a minimum set rate, even during periods of rest, or they act as a boost to the heart’s natural system when it’s not providing enough impulses.

On-Demand Pacemakers:

• Other pacemakers are designed to activate only when they are needed. They send electrical impulses only when the heart rate falls below a certain point.
• These devices continuously monitor the heart’s electrical activity so they know when to intervene and when to stay dormant.
•  People with this type of pacemaker usually have a heart that functions properly most of the time. However, they may experience episodes where the pacemaker needs to kick in to keep things functioning naturally.
• These are also known as “demand” pacemakers.

Hear From Real People Impacted by the Boston Scientific Recall

First-hand accounts from patients can really paint a clear picture of the distress, danger, and impact that these defective medical devices can cause. Here are a few reactions to the Boston Scientific pacemakers recall:

“My dad’s Accolade just went into safety mode last week. He was feeling awful for days – super tired, dizzy. The docs said the battery was failing way too early. Now he’s scheduled for an emergency replacement. He’s 78, and we’re terrified about another surgery.” – Reddit User, r/pacemakers

“I was told [my Accolade pacemaker] went into Safety Mode during a routine check. The technician looked concerned and immediately called my cardiologist. It turns out it was one of the recalled ones. Now I’m looking at surgery I wasn’t prepared for, mentally or financially.” — Reddit user, r/medicaldevices

“Boston Scientific pacemaker went dead after 4 years. It was an Altrua 2. Had to get emergency explant. Woke up in the ICU. This shouldn’t happen. The recovery was brutal, and I missed weeks of work.” — Reddit user, r/healthissues

“Doc says I’m high risk because I’ve had two previous implants and now have to replace this Boston Scientific one again due to the recall. I’m scared. Each surgery takes a toll, and the thought of leads getting damaged is always there.” — Reddit user, r/legaladvice

“Found out my Essentio was recalled through a letter. Called my doctor, and they confirmed it. Said something about ‘high internal cell impedance’ and it could just stop working right. The anxiety is the worst part, just waiting and wondering if today’s the day it fails.” – Reddit User, r/chronicillness

Symptoms of Pacemaker Malfunction

If you have one of the affected pacemakers, you need to know the warning signs of it malfunctioning, which can indicate the device has, or is about to, permanently enter safety mode. These symptoms can emerge suddenly and require immediate medical attention:

• Dizziness or Lightheadedness: Caused by insufficient blood flow to the brain when the heart rate drops too low.
• Syncope (Fainting or Near Fainting): A more severe consequence of reduced cerebral blood flow due to bradycardia or other arrhythmias not beincorrectly manageded by the pacemaker.
• Palpitations or Irregular Heartbeats: The pacemaker may fail to regulate the heartbeat effectively, leading to noticeable and uncomfortable rhythm disturbances.
• Chest Pain (Angina): Can occur if the heart muscle isn’t receiving enough oxygen due to poor blood flow.
• Severe Fatigue or Weakness: A common symptom when the heart isn’t pumping efficiently.
• Shortness of Breath (Dyspnea): Especially during exertion, but can also occur at rest if cardiac output is significantly compromised.
• Bradycardia: An inappropriately slow heart rate, which the pacemaker is supposed to prevent. If the device is in safety mode, it may pace at a fixed, slow rate that is inadequate.
• Symptoms of Heart Failure: Swelling in the legs or abdomen, persistent cough, or difficulty breathing when lying down can indicate the heart is struggling due to a pacemaker malfunction.

Pacemaker Malfunction Increases Stroke Risk

One of the most dangerous issues with these defective pacemakers is intermittent failure to capture.

Failure to capture is when the pacemaker tries to send an electrical signal, but your heart doesn’t respond. It can be caused by multiple issues, but on that list are: low battery (due to HICI) or the device being stuck in Safety Mode.

If intermittent failure to capture happens at the wrong time, it could lead to cardiac arrest and be the difference between walking into your doctor’s office and being wheeled into an emergency room.

Patients with atrial fibrillation are at an even higher risk. If your pacemaker fails to provide adequate rate support or anti-tachycardia pacing, your risk of stroke skyrockets by as much as five times. This is because an improperly managed atrial fibrillation can lead to blood clot formation in the heart, which can then travel to the brain and cause a stroke.

Pacemaker Replacement and Its Risks

If your device has entered Safety Mode or is at risk of entering permanent Safety Mode, your doctor may recommend replacing the pacemaker. The replacement process involves surgically removing the faulty device and implanting a new one.

While often life-saving, pacemaker replacement surgery is not without risks, especially for older adults or those with other medical conditions:

• Infection at the surgical site or in the bloodstream.
• Hematoma (bleeding or bruising) at the implant site.
• Lead dislodgement or damage during the procedure.
• Pneumothorax (collapsed lung) is a rare complication.
• Adverse reaction to anesthesia.
• Damage to blood vessels or nerves.
• Pain and discomfort at the implant site during recovery.
• Psychological distress associated with undergoing another surgery and the uncertainty of a device recall.

If you have one of these recalled devices, your healthcare provider should be monitoring your condition closely. Regular follow-up visits, battery longevity assessments, and remote monitoring are all part of the recommended care strategy.

Expert Commentary: The Legal and Emotional Toll

Attorney Matthew Dolman, who has handled thousands of defective device and personal injury cases, said the following about the dangers of these pacemaker failures:

“Defective medical devices, especially internal medical devices, are one of the most dangerous types of product failures because they’re often implanted directly into the human body, where they’re supposed to help, not harm. When a pacemaker malfunctions, it’s not just an inconvenience or a faulty product; it’s a life-threatening emergency. The heart relies on precise timing, and a defective pacemaker can mean the difference between stability and sudden cardiac arrest. For our clients, the betrayal isn’t just physical,l it’s emotional. They trusted a medical device to keep them alive. When that trust is broken, the consequences can be devastating.”

—Matthew Dolman, Defective Medical Device and Defective Medication Lawyer and Owner of Multiple Mass Tort Law Firms

Has Boston Scientific Faced Similar Lawsuits Before?

This isn’t the first time that Boston Scientific has been liable for defective surgical implants. Boston Scientific has a history of litigation over defective cardiac devices and other defective medical devices.

• Guidant Defibrillators (Acquired by Boston Scientific): In 2011, Boston Scientific paid $30 million to resolve claims of knowingly selling faulty Guidant defibrillators with short-circuiting risks, after Guidant faced U.S. Department of Justice charges for misleading the FDA.
• Cognis and Teligen Pacemakers (2009): Certain Cognis and Teligen pacemakers were recalled due to a manufacturing error causing premature battery depletion, similar to the current HICI issue.
• Transvaginal Mesh Lawsuits: Boston Scientific has paid hundreds of millions to settle thousands of claims alleging its transvaginal mesh products were defectively designed, causing severe complications. This illustrates a broader pattern concerning their medical implants.
• Filter Lawsuits: The company faced litigation over its Greenfield Vena Cava Filters, with allegations of devices fracturing and migrating, causinsevereus internal injuries.

This pattern of recalls and lawsuits adds another concerning element to the current Accolade pacemaker issues.

How Defective Medical Devices Can Affect Your Life

The implantation of a medical device is meant to improve or save a life. When that device is defective, like some Boston Scientific pacemakers, the impact can be devastating.

Beyond immediate physical harm, patients often face emergency medical interventions, significant pain and suffering, and mounting medical expenses. The time off work for treatment and recovery can lead to lost wages and profound anxiety about a device failing.

Long-term, individuals may suffer chronic health complications, require ongoing medical monitoring, and experience a reduced quality of life. The financial and emotional strain of all this can be immense, sometimes leading to psychological trauma, depression, and other mental illnesses.

This breach of trust is common in cases involving defective medical devices, which can range from faulty joint replacements to problematic cardiac implants. Sometimes, the issue isn’t the device itself but the care received, potentially leading to questions about medical negligence.

The consequences can also be similar to those experienced by victims of defective drugs, where a product intended to help causes unforeseen harm.

These ripple effects really underscore the critical need for accountability when it comes to negligence in the medical manufacturing industry.

Am I Eligible to File a Boston Scientific Accolade Pacemaker Lawsuit?

You may qualify to file an Accolade pacemaker lawsuit if:

• Implanted Device: You or your family member had a recalled Boston Scientific pacemaker (such as Accolade, Proponent, Essentio, Altrua 2, Visionist, or Valitude models) implanted, particularly those manufactured before September 2018.
• Device Malfunction or Failure: The pacemaker failed, malfunctioned, or permanently entered safety mode. This includes issues like:
  • Premature battery depletion due to high internal cell impedance (HICI).
  • Unexpected entry into Safety Mode.
  • Failure to pace or sense correctly.
  • Causing or worsening irregular heartbeats.
• Resulting Injury or Harm: You or your family member suffered physical injury, emotional distress, or financial loss as a direct result of the device’s malfunction. This includes, but is not limited to:
  • Symptoms like dizziness, fainting (syncope), chest pain, severe fatigue, or bradycardia.
  • Need for emergency medical treatment.
  • Necessity for early device replacement surgery (explant and reimplantation).
  • Complications from the replacement surgery.
  • Worsened cardiac condition.
  • Significant emotional distress and anxiety related to the device failure or risk of failure.
• Wrongful Death: A family member passed away due to complications arising from the recalled pacemaker’s failure.

If you are unsure whether your situation qualifies, it is crucial to seek legal advice. Don’t let uncertainty prevent you from exploring your options. You can contact Dolman Law Group using the form on this page or by calling the number at the top of your screen.

How a Defective Pacemaker Lawyer Can Help

Medical device recalls are overwhelming, dangerous, anxiety-inducing, and of course, the stakes couldn’t be higher. You trusted this device with your life and you deserved a product that was effective and adequately tested. A defective pacemaker lawyer can help you by:

• Determining If You’re Affected by the Recall: Your attorney will meticulously review your medical records, consult with your cardiologist if necessary, and cross-reference device model and serial numbers with official recall lists to definitively confirm if your pacemaker is one of the recalled Boston Scientific devices. They can help decipher complex medical jargon and ensure no detail is overlooked.
• Proving Causation Between Your Accolade Pacemaker and Your Injuries: Establishing a clear link between the defective pacemaker and your injuries, known as causation, is critical. A lawyer experienced in these cases can gather and analyze medical evidence, consult with medical experts, and build a strong argument demonstrating how the device’s failure directly led to your physical harm, emotional distress, and financial losses, even if complications arose months or years post-implantation.
• Holding Boston Scientific Accountable: By filing a claim, you are not just seeking compensation for yourself; you are joining a collective voice demanding accountability from a major corporation. Your lawyer will navigate the complex legal system to ensure Boston Scientific is held responsible for manufacturing defects, failing to warn patients adequately, and putting profits before patient safety. This can contribute to changes that prevent future harm to others.
• Filing a Wrongful Death Claim: If you have tragically lost a loved one because of a malfunctioning Accolade or other recalled Boston Scientific pacemaker, an attorney can provide compassionate and skilled representation. They will guide your family through the process of filing a wrongful death lawsuit, aiming to secure justice for your loss and compensation for the profound impact it has had on your family.

Don’t face this alone. Experienced legal representation can make all the difference in navigating these complex claims and securing the justice you deserve. If you suspect your injury or the death of a loved one was caused by a Boston Scientific pacemaker involved in this recall, contact Dolman Law Group immediately.

Getting Financial Compensation for Damages Caused by Your Defective Pacemaker

If you’ve been harmed by a defective Boston Scientific pacemaker, you may be entitled to significant financial compensation for the various losses you’ve incurred. A successful lawsuit can help recover damages for:

Medical Bills

This includes all costs associated with the defective pacemaker, such as emergency room visits, hospitalizations, surgeries, medications, rehabilitation, and anticipated future medical care.

Pain and Suffering

Compensation covers physical pain from device malfunction, surgeries, and recovery, as well as mental and emotional anguish, including anxiety, fear, depression, and loss of enjoyment of life.

Lost Wages or Income

If the pacemaker failure or replacement surgery caused you to miss work or diminished your future earning capacity, you can be compensated for lost salary, bonuses, and benefits.

Wrongful Death Compensation

If a defective pacemaker caused a patient’s death, surviving family members may recover damages for funeral expenses, loss of financial support, and loss of companionship and guidance.

Punitive Damages

These damages may be awarded in cases of particularly reckless or negligent company conduct, serving to punish the wrongdoer and deter future similar actions.

File a Boston Scientific Defective Pacemaker Claim Today

No one should have to go through a medical emergency because of a company’s manufacturing mistake. If you or someone you love was harmed by a defective Boston Scientific pacemaker, you deserve answers and justice.

We have handled thousands of defective implant cases (like the Bard PowerPort lawsuit), defective medical device cases (like the CPAP cases and Paragard IUD claims), defective products (like the ongoing toxic baby food cases and chemical hair relaxer cases), defective medications (like Suboxone and Ozempic), and so many more. We are also well-known for taking on some of the largest corporations in the world and battling it out with them in the courtroom.

At Dolman Law Group, our product liability lawyers are following this developing story closely and helping families take legal action against Boston Scientific. Reach out today to learn more about your rights and your options. You could be eligible to join others in pursuing a Boston Scientific Accolade pacemaker lawsuit.

Don’t wait. Your health and peace of mind are too important to put on hold.

Frequently Asked Questions

What is the Boston Scientific pacemaker recall about?

It concerns battery defects (often high internal cell impedance or HICI) in certain pacemakers, like the Accolade, causing them to potentially enter a permanent, unsafe “Safety Mode.”

Which pacemakers are affected?

The recall includes the Accolade family, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE, mainly those made before September 2018.

What happens when a pacemaker enters Safety Mode?

It reverts to basic, non-programmable default settings that may not adequately support the patient’s heart condition.

What are the symptoms of a malfunctioning pacemaker?

Symptoms include dizziness, fainting, fatigue, chest pain, shortness of breath, or irregular heartbeats.

How many injuries have been reported?

Over 800 injuries and at least two deaths have been linked to these recalled pacemakers.

Can my recalled pacemaker be fixed?

No, the internal defect is not repairable; the pacemaker generator typically requires surgical replacement.

Is there a tool to check if my device is part of the recall?

Yes, Boston Scientific has a device lookup tool on its website, or you can contact your cardiologist to make sure since that may give you more peace of mind.

Can I file a lawsuit if my recalled pacemaker harmed me?

Yes, if you suffered harm, complications, or needed early replacement surgery due to the defect, you may be eligible for compensation.

What if my recalled pacemaker hasn’t malfunctioned yet?

If your doctor recommends preventive replacement due to recall risks, you might still have a claim for the associated costs and distress. However, it is unclear if these claims are valid or not. Contact Dolman Law Group or bookmark this page to find out as soon as we know. We will be posting updates to this page.

How much does it cost to hire a lawyer for a pacemaker lawsuit?

Most product liability lawyers, like those at Dolman Law Group, work on a contingency fee basis, meaning you pay nothing unless they win your case.

What should I do if my doctor says my recalled pacemaker is fine for now?

Continue close monitoring with your doctor, but also consult a lawyer to understand your legal rights and options regarding the recall.

How long do I have to file a Boston Scientific pacemaker lawsuit?

Each state has a statute of limitations, so it’s crucial to contact a lawyer as soon as possible to protect your claim.