Boston Scientific Accolade Pacemaker Recall Lawsuit | June 2025

800 Injuries and Multiple Deaths Have Been Linked to Defective Pacemakers Made by Boston Scientific, Sparking a Major Recall and Wave of Lawsuits. Keep Reading to Learn If You Qualify to File a Lawsuit Due to Your Defective Pacemaker.

— Approximately 203,000 Accolade pacemakers and others made by Boston Scientific Have Been Recalled. 

— The recall affects any devices that were manufactured before September 2018. 

— Boston Scientific's pacemakers are under a Class I recall, the FDA's most serious warning level.

— The recall doesn't just impact Accolade devices; it includes Proponent, Essentio, Altrua, Visionist, and Valitude pacemakers.

— The FDA urges patients to contact their cardiologists ASAP for advice on what to do next.

— This issue is being caused by a battery defect that can cause the pacemaker to suddenly fail, leaving patients vulnerable to life-threatening complications.

---

The FDA has issued its highest level recall for the family of Accolade pacemakers made by Boston Scientific, along with many of their other pacemaker devices. These defective medical devices have led to over 800 serious injuries and multiple deaths as of the writing of this article, and those numbers are sure to go up. With other recalled items, people can usually throw them away or stop using them as soon as they see the recall. For example, the Ninja Foodie pressure cookers that are giving people third-degree burns; you see the recall and stop using them. But with an implanted device that is literally hooked to your heart, that option doesn't exist. This has led to hundreds of thousands of people living in constant fear over whether their Boston Scientific pacemaker is going to just stop working at any moment. 

This massive case of negligence on the part of Boston Scientific and its line of pacemakers has naturally sparked a wave of personal injury lawsuits. This is a critical failure that demands accountability. And like I said, the harm here goes way beyond physical injuries and death, although those are rampant and serious. These defective medical devices have created a deep betrayal of trust that has a massive amount of patients living in fear and uncertainty.

Which Specific Boston Scientific Pacemakers Are Recalled?

According to the FDA and Boston Scientific's own statements, the following pacemakers are part of this important FDA Class I medical device 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)

If you have concerns about your specific Boston Scientific pacemaker, contact your cardiologist or cardiac care provider immediately. Understanding your legal rights and options regarding this pacemaker recall is also a critical step.

What is a Pacemaker?

A pacemaker is a small, battery-operated device that is implanted in a person's chest to help regulate a person's heartbeat. It sends electrical signals to the heart, causing it to contract like it would on its own. This ensures the heart beats at a steady, proper rate. 

Pacemakers are most commonly implanted when the heart's natural rhythm isn't working as it should but it can also be used for people who are at risk of their heart stopping and need a jump.

There are two main types of pacemakers: continuously active pacemakers and on-demand pacemakers.

Continuously Active Pacemakers and On-Demand Pacemakers

Continuously Active Pacemakers: These are "on" all the time, helping the heart to maintain a consistent heart rate. Patients who rely on this constant support are considered "pacemaker-dependent."

On-Demand (​​Synchronous) Pacemakers: These only activate when needed, continuously monitoring heart activity and intervening if the heart rate drops too low.

The defective Boston Scientific pacemakers involved in this recall involve both types of pacemakers.

Safety Mode: How Defective Boston Scientific Pacemakers Are Failing

The core of this issue is a manufacturing defect with the batteries in the pacemakers that causes them to be faulty, leading to a condition known as High Internal Cell Impedance (HICI). Simply put, HICI causes the battery's power to drop significantly, forcing the pacemaker device to go into "Safety Mode."

While Safety Mode is designed as a backup to help prevent any catastrophic repercussions if the battery fails, in this case, the HICI issue is causing the pacemaker to unintentionally reset over and over again.

Defective Pacemakers in Safety Mode Lead to Default Factory Settings

If a reset occurs repeatedly (usually three times within a 48 hour period) the device can become permanently stuck in Safety Mode. When this happens, the defective pacemaker stops functioning properly and reverts back to its default factory settings instead of the personalized pacing that was programmed for the patient's specific heart condition.

For individuals whose hearts rely on constant, precise pacing, this malfunction can be catastrophic. Once the pacing is off rhythm or the battery is not producing enough power to operate the pacemaker, it leads to severe bradycardia (an abnormally slow heart rate) or other life-threatening irregular heart rhythms. 

This constant worry about a Boston Scientific pacemaker battery failure can be a heavy emotional burden for someone to bear. Anyone who has a Boston Scientific pacemaker that is on the recall list should contact your doctor or cardiologist as soon as possible. 

The Human Cost: Injuries, Deaths, and Patient Stories from Accolade Failure

The numbers are stark. The FDA has confirmed that defective pacemaker devices from Boston Scientific have already caused 832 serious injuries and contributed to at least two deaths. 

Many of these devastating issues surfaced during routine monitoring sessions, whether in a doctor's office or via remote systems, leaving patients in shock.

Beyond the statistics, real people are living with the profound impact of these failures:

"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

Some patients face even higher risks. Those with previous heart surgeries or who have pacemakers that are connected to multiple parts of their heart (meaning they have a device with multiple leads or wires going to different areas of their heart) are more susceptible to severe complications and often require urgent intervention, all of which adds to their physical pain and emotional distress.

Recognizing the Symptoms of a Defective Pacemaker

If you have one of the affected Boston Scientific pacemakers, recognizing the warning signs of it malfunctioning is critical. These symptoms can appear suddenly and require immediate medical attention:

• Dizziness or Lightheadedness: Dizziness is often caused by insufficient blood flow to the brain due to a dangerously low heart rate.
• Syncope (Fainting or Near Fainting): Syncope is a more severe symptom resulting from reduced blood flow, leading to a brief loss of consciousness.
• Palpitations or Irregular Heartbeats: The pacemaker fails to regulate the heart effectively, causing noticeable and uncomfortable rhythm disturbances and palpitations.
• Chest Pain (Angina): Angina occurs when the heart muscle isn't receiving enough oxygen due to poor blood flow.
• Severe Fatigue or Weakness: Feeling weak or extreme fatigue, is a common indicator when the heart isn't pumping blood efficiently throughout the body.
• Shortness of Breath (Dyspnea): During exertion, or even at rest, the heart's output can become significantly compromised and causes a person to feel short of breath (because they don't have enough oxygen in their blood). This is known as dyspnea.
• Bradycardia: Bradycardia is the term for a very slow heartbeat, which is the point of a pacemaker. If the device is in Safety Mode, it may cause the heart to beat at an inadequately slow rate.
• Symptoms of Heart Failure: Noticing the common signs of heart failure, like swelling in the legs or abdomen, a persistent cough, or difficulty breathing when lying down, can alert you that the heart is struggling, possibly due to a pacemaker malfunction.

Defective Pacemakers Put Patients At Risk of Cardiac Arrest and Stroke

One of the most dangerous consequences of these defective pacemakers is known as "intermittent failure to capture." This is when the device sends an electrical signal, but the heart fails to respond. 

This can be caused by the low battery or the device being stuck in Safety Mode, both of which are problems here. 

If this occurs at a critical time when the heart needs the full power of the pacemaker, it can lead to sudden cardiac arrest. 

For patients with atrial fibrillation (an irregular and often rapid heartbeat), a malfunctioning pacemaker can increase the risk of stroke by as much as five times and double the risk of death, since atrial fibrillation that is not properly treated with an effective pacemaker can lead to dangerous blood clot formations. 

Oftentimes, patients do not know that their pacemaker is not working properly and think that their atrial fibrillation is being properly managed.

What to Do If You Have a Recalled Boston Scientific Pacemaker

The discovery that your life-sustaining medical device is defective can be terrifying. This is true for lots of medical implants, but doubly true for something as important as a pacemaker. Because of this, it's vital to know the immediate steps you should take to protect your health and legal rights.

• Contact your cardiologist immediately. Do not wait for symptoms to appear if you know your device is on the recall list. Your doctor can monitor your device and advise on the best course of action.
• Do NOT attempt tamper with the device. This is a medical decision that must be made by your healthcare provider.
• Monitor for symptoms. Be vigilant for any of the signs of pacemaker failure listed above, and report them to your doctor right away.
• Gather your medical records. Keep all documentation related to your pacemaker implantation, follow-up appointments, and any complications. This is crucial for both your medical care and any potential filing a pacemaker lawsuit.
• Consult with a qualified defective medical device lawyer. Understanding your legal options early on is critical.

Replacing a Defective Pacemaker and Its Risks

For those with defective devices that have entered Safety Mode or are at high risk of entering permanent Safety Mode, doctors often recommend that they receive a new surgical implant. This involves removing the faulty device and implanting a new one, a daunting prospect that adds to the patient's physical and emotional toll.

While often life-saving, pacemaker replacement surgery carries its own set of risks, particularly for older adults or those with pre-existing 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 but serious complication.
• Adverse reactions to anesthesia.
• Damage to surrounding blood vessels or nerves.
• Pain and discomfort at the implant site during recovery.
• Profound psychological distress associated with undergoing another surgery and the constant uncertainty of a recalled medical device.

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

How to Pursue a Boston Scientific Pacemaker Lawsuit

If you or a loved one has been harmed by a defective Boston Scientific pacemaker, you have the right to seek justice and compensation. You may qualify to file a lawsuit if:

• Implanted Device: You or your family member had a recalled Boston Scientific pacemaker implanted, such as Accolade, Proponent, Essentio, Altrua 2, Visionist, or Valitude models, 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, or failure to pace or sense correctly, causing or worsening irregular heartbeats.
• Resulting Injury or Harm: You or your family member suffered physical injury, significant emotional distress, or financial loss directly due to the device's malfunction. This encompasses symptoms like dizziness, fainting, chest pain, severe fatigue, or bradycardia; the need for emergency medical treatment or early device replacement surgery; complications from replacement surgery; a worsened cardiac condition; or profound anxiety related to the device failure.
• Wrongful Death: A family member tragically 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 promptly. Don't let uncertainty prevent you from exploring your options for a personal injury lawsuit.

What to Expect from a Defective Medical Device Lawsuit 

When you decide to pursue a defective medical device lawsuit like the Boston Scientific Accolade pacemaker lawsuit, you're entering a specialized area of law. Here's a general overview of what to expect:

• Investigation and Evidence Gathering: Your attorney will meticulously gather all relevant medical records, device information, and evidence of your injuries. This includes consulting with medical experts to establish a clear link between the defective pacemaker and the harm you suffered.
• Filing the Complaint: Once sufficient evidence is compiled, a formal legal complaint is filed against Boston Scientific. This document outlines the legal basis for your claim and the damages you are seeking.
• Discovery Process: Both sides exchange information, including documents, interrogatories (written questions), and depositions (out-of-court sworn testimonies). This phase helps build each side's case.
• Negotiation and Settlement: Many defective medical device lawsuits are resolved through negotiations and settlements outside of court. Your lawyer will negotiate on your behalf to secure fair compensation.
• Trial (if necessary): If a fair settlement cannot be reached, the case may proceed to trial, where a judge or jury will hear the evidence and make a decision.
• Multidistrict Litigation (MDL) Potential: Due to the large number of people affected by a single defective medical device, these cases often become part of a Multidistrict Litigation (MDL). An MDL centralizes similar lawsuits from different federal districts into one court under one judge. This streamlines the legal process, manages discovery efficiently, and often leads to consolidated settlements. If an MDL is formed for the Boston Scientific Accolade pacemaker lawsuits, your case would likely become part of it.

How an Experienced Defective Medical Device Lawyer Can Help

Hiring an expert lawyer can be a huge help in this process. The difference between an attorney who has never handled a complicated medical case and one who has handled thousands of miles apart. We have handled all types of defective medical devices, defective medications, chemical exposures, and cases against some of the largest corporations in the world.

We will handle every step of the process so you can focus on your recovery.

• Determining Your Eligibility: Our legal team will meticulously review your medical records, consult with your cardiologist, and cross-reference details with official information from Boston Scientific. We will ensure no crucial detail is overlooked.
• Proving Causation: Establishing a clear link between the defective pacemaker and your injuries is paramount. Using our experience in these types of cases, we will gather and analyze the 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.
• Holding Boston Scientific Accountable: By filing a pacemaker lawsuit, you are not just seeking compensation for yourself; you are helping to demand accountability from major corporations—something that is seriously lacking in this country. Giant companies have been harming our babies with toxic baby food, getting our children addicted to online games and social media, taking advantage of the people in our society who are trying to better themselves, and seemingly giving a giant group of people cancer every few years or so.
• Filing a Wrongful Death Claim: If you have tragically lost a loved one due to a malfunctioning Accolade or other recalled Boston Scientific pacemaker, our team of attorneys will be right here to provide you with compassionate and skilled representation. We will file a wrongful death lawsuit on your behalf, seek justice for your unimaginable loss, and get compensation for the profound impact it has had on your family.
• Get Financial Compensation for Your Damages: If you've been harmed by a defective Boston Scientific pacemaker, you may be entitled to significant financial compensation for the losses you've incurred. A successful lawsuit can get you the money you need to cover your bills and lost wages, as well as compensate you for all the pain and suffering.

Compensation in a Defective Pacemaker Lawsuit

• Medical Bills: Covers all costs related to the defective pacemaker, including surgeries, hospital stays, and ongoing care.
• Pain and Suffering: Compensates for physical pain and emotional distress from the device malfunction and its consequences, including anxiety and fear of future complications.
• Lost Wages or Income: Reimburses you for any income lost due to missed work or reduced earning capacity.
• Punitive Damages: If this case ends up getting combined into a multidistrict litigation, the judge may decide to award punitive damages if they believe that extreme negligence was involved as a way to punish the company and prevent future misconduct from other companies.

Take Action: File a Boston Scientific Defective Pacemaker Claim Today

No one should endure a medical emergency or suffer devastating consequences due to a company's manufacturing mistake. If you or someone you love was harmed by a defective Boston Scientific pacemaker, you deserve answers and justice.

The stakes are too high to wait. Contact us today to learn more about your options. You could be eligible to join others in pursuing a Boston Scientific Accolade pacemaker lawsuit.

Frequently Asked Questions about the Boston Scientific Recall