As part of our continuing effort to fight for patients injured by defective heart devices, we posted information about the Boston Scientific recall, specifically the Accolade Pacemaker recall. Certain models of the Accolade pacemaker have a battery issue that may necessitate surgery to replace it. The following information is about that pacemaker recall.

Our partner, Robert Price, is heading up this litigation. He is a preeminent medical device attorney who handles many medical device implant cases, including BioZorb, hernia mesh, and Impella. He is currently leading multiple litigations on behalf of other lawyers by leading the science and expert workup of these litigations. Find out how he can help you if you had the Accolade pacemaker.

The Boston Scientific Pacemaker Recall

FDA announced the Accolade recall in late 2024. The recall concerns “[t]he Accolade devices[,] … a family of pacemakers and cardiac resynchronization therapy pacemakers that [surgeons implant] to treat abnormal heartbeat (arrhythmia) and moderate to severe heart failure.” The problem is the batteries may deplete sooner than expected. As FDA noted, “[t]his recall involves the potential need for device explant.”

This continues making rounds in online media. We hope it helps more patients learn of the risks, and for those already injured, become aware they have legal rights. A product liability lawyer can bring a claim if you suffered an injury from an Accolade Pacemaker. Our experienced medical device attorneys have the expertise to navigate the complex legal issues surely to arise. Contact us if a loved one died with an Accolade pacemaker.

Two Patients Died Using the Accolade Pacemaker per Online Reports

The risk that caused the recall is the battery failing. A recent online report explained it succinctly: “The company announced a recall for a subset of its Accolade devices because of an increased risk of permanently entering the safety mode. This has limited functionality, making the device unable to properly regulate the heart’s rhythm and rate. Most of the activations have occurred during follow-up office or hospital visits when the devices are interrogated for data.”

Most concerning is two deaths preceded the Accolade recall. Id. “There have been two reported patient deaths in pacemaker dependent patients after the devices went into safety mode in an ambulatory outpatient medical setting. Boston Scientific said about 70% of safety mode events occurred during in-office interrogations from a Latitude programmer, and the remaining incidents took place in an ambulatory setting.”

There were also 832 injuries per FDA’s recall notice.

The FDA recall notice concerning the Boston Scientific pacemaker, noted 832 injuries. There were no details provided. Many reports submitted to FDA are self-reports, and unverified. Nonetheless, this was enough to prompt a recall. More recently, FDA cited these same death and injury numbers when announcing the So these pacemaker precautions seem pertinent. The Accolade pacemaker is one we will continue to investigate.

At Least Hundreds of Accolade Devices at Issue

As we posted when we first blogged about the Accolade recall, it concerns a subset of Accolade pacemakers. The same report cited above noted

subset of the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronization therapy (CRT) pacemakers. The number of impacted devices is about 203,000, while the tally of confirmed malfunctions is 697, Boston Scientific said in its recall notice

If You Suffered an Injury Using the Accolade Pacemaker or a Loved One Died Having Used One, Contact KBA

We anticipate more deaths attributed to these Accolade pacemakers. Anyone an Accolade implant injured should contact KBA at 855-KBA-LAWS (522-5297). The pacemaker lawyer is here to help.

What is a Pacemaker?

The accolade pacemaker is one of many medical devices doctors sometimes implant to help regulate the heart’s rhythm. Generally, pacemakers consist of a battery-powered component that generates an electric impulse. Remember, our hearts pump via electricity in part. Cells generate an electric signal, which passes through the heart muscle causing it to contract. A pacemaker like the Accolade replicates this through a generator. 

The generator has wires from the device to the heart. At the tips of these leads are sensors that detect the heart’s natural electric signals and deliver impulses as necessary. The Boston Scientific Accolade Pacemaker is a family of medical devices. It contains a sensor to help in this process. Its efficacy turns on having sufficient power, and that is the subject of the Accolade recall. 

Boston Scientific Accolade Pacemaker Recall: Critical Safety Information and Patient Guide

Key Takeaways about the Boston Accolade Pacemaker

• Boston Scientific recalled approximately 203,000 Accolade and related pacemaker models due to critical battery issues
• Two patient deaths have been reported due to devices entering “Safety Mode”
• Affected models include Accolade, Proponent, Essentio, Altrua 2, Visionist, and Valitude devices manufactured before September 2018
• Patients with affected devices should seek immediate medical consultation but avoid prophylactic replacement unless specifically indicated

In December 2024, Boston Scientific initiated a Class I recall of several pacemaker models due to a severe manufacturing defect affecting the battery system. This critical safety issue can cause devices to unexpectedly enter “Safety Mode,” significantly limiting their ability to regulate heart rhythm and potentially leading to life-threatening complications.

What Accolade Pacemaker is this recall about?

This pacemaker recall concerns the potential need for early device replacement of Boston Scientific Corporation (Boston Scientific) Accolade pacemaker devices, which includes the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronization therapy pacemakers. Per the Boston Scientific recall, it covers a subset of approximately 13% of devices from the ACCOLADE family, built before Sep 2018. The ACCOLADE™ family refers to Boston Scientific pacemakers trademarked as the ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 Standard Life (SL), and Extended Life (EL). It also includes the VISIONIST cardiac resynchronization therapy pacemaker and the VALITUDE cardiac resynchronization therapy pacemaker (CRT-P).

Health Risks and Reported Incidents

Confirmed Cases and Fatalities

• 697 confirmed device malfunctions
• Two reported deaths in pacemaker-dependent patients
• Approximately 70% of Safety Mode activations occurred during routine office visits
• Remaining incidents happened in ambulatory settings

Understanding the Safety Mode Issue

When affected devices enter Safety Mode, they experience:

• Limited functionality
• Inability to properly regulate heart rhythm
• Reduced capacity to adjust to patient activity levels
• Potential complete loss of pacing support

Important Patient Information

We cannot provide medical advice, so do not rely on this. Rather, you should speak with a healthcare provider. However, information we found follows.

Immediate Steps for Patients

1. Do Not Panic: Not all devices will experience this issue
2. Contact Your Healthcare Provider: Schedule an immediate consultation
3. Know the Warning Signs:
   • Dizziness
   • Lightheadedness
   • Fainting or near-fainting episodes
   • Unusual heart rhythms
   • Shortness of breath

Monitoring and Follow-up Care

Regular monitoring is essential through:

• Scheduled in-office device checks
• Remote monitoring via Boston Scientific Latitude Communicator
• Immediate reporting of any concerning symptoms

Legal Rights and Options

If the Accolade pacemaker recall impacts you, you may be entitled to compensation for:

• Medical expenses including additional surgical procedures
• Lost wages
• Pain and suffering
• Other related damages

When to Seek Legal Assistance

Consider consulting with a medical device attorney if:

• Your device has entered Safety Mode
• You’ve experienced health complications
• A family member died while using an affected device
• You’ve required additional surgical procedures

Contact Information and Support

For immediate assistance and legal consultation regarding the Boston Scientific Accolade pacemaker recall, contact KBA Attorneys:

• Phone: 855-KBA-LAWS (522-5297)
• Available 24/7 for urgent consultations
• Free initial case evaluation
• Experienced in complex medical device litigation

Additional Resources

• FDA Recall Information
• Boston Scientific Safety Notice
• Heart Rhythm Society Guidelines

Boston Scientific Accolade Pacemaker Recall:

We have covered the basics of the Boston Scientific pacemaker recall above. Now, let’s get into some Frequently Asked Questions

1. What is the Boston Scientific Accolade Pacemaker Recall?

In December 2024, Boston Scientific announced a recall for certain Accolade pacemaker devices due to a manufacturing issue that may cause the device to enter “Safety Mode,” limiting its functionality. This mode can prevent the pacemaker from properly regulating the heart’s rhythm and rate, potentially leading to serious health risks.

fda.gov

2. Which pacemaker models does the pacemaker recall concern?

The Accolade recall affects specific models within the Accolade family, including:

• ACCOLADE™
• PROPONENT™
• ESSENTIO™
• ALTRUA™ 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers
• VISIONIST™
• VALITUDE™ cardiac resynchronization therapy pacemakers (CRT-Ps)

These devices were manufactured before September 2018. bostonscientific.com

3. What are the risks that the Accolade pacemakers may present?

The primary concern is that the Accolade pacemakers may permanently enter Safety Mode due to a battery issue. In this mode, the device’s ability to regulate heart rhythm is compromised. That can lead to symptoms such as lightheadedness, loss of consciousness, or even death in pacemaker-dependent patients. There have been reports of two patient deaths linked to this issue.  fda.gov

4. What injuries might the Accolade recall cause?

People may suffer a cardiac event or die because of this issue. This is not the first time we have seen problems with pacemaker batteries. Here, FDA’s announcement of the Accolade pacemaker recall expressly identified another injury many patients with an Accolade pacemaker will suffer, “[t]his recall involves the potential need for device explant.” Meaning, patients may need to undergo another surgery to swap out the old with a new medical device. Each surgery presents its own risk.

5. How can I determine if my pacemaker is part of the recall?

Patients should consult with their healthcare providers to review their device model and serial number. Regular monitoring through in-office visits or remote monitoring systems, like the Boston Scientific Latitude Communicator, can help detect if a device has entered Safety Mode. We can also obtain your medical records to check.

6. What steps should I take if my pacemaker is one  of the Accolade recall devices?

If your device is identified as part of the recall:

• Consult Your Healthcare Provider: Discuss the potential risks and benefits of device replacement.
• Regular Monitoring: Ensure consistent follow-ups to detect any device malfunctions promptly.
• Report Symptoms: Immediately inform your doctor if you experience symptoms like dizziness or fainting.

The FDA recommends against general prophylactic device replacement unless the device has entered Safety Mode.

7. Can I pursue legal action if I’ve been affected by the recall?

If you or a loved one have suffered adverse effects due to an affected Accolade pacemaker, you may be eligible for compensation. Legal claims can address medical expenses, pain and suffering, and other related damages. Consulting with experienced attorneys can help you understand your rights and options.

8. How can I stay updated on the recall and related legal actions?

Stay informed by regularly checking updates from the FDA and Boston Scientific. Additionally, legal firms specializing in medical device recalls often provide current information and guidance on potential legal actions.

FDA MAUDE Database Findings Concerning the Accolade Pacemaker

One of the things a medical device attorney investigates when looking into a medical device recall is FDA’s databases. It has several.

There are pre-market databases. These databases that provide information regarding how the product got on the market. Generally, there are two ways medical devices get to patients in the U.S. You can learn more on our medical device page here, https://kbaattorneys.com/mass-tort-class-action/defective-medical-device-lawsuit/#The_FDA_gateway_Two_roads_diverged.

Another category of FDA databases concern adverse events. Technically the phrase, “adverse event,” appears in pharmaceutical post-market surveillance. A drug related database at FDA is FAERS. There is also Legacy Adverse Event Reporting System (AERS) for older ones.

On the medical device side, we refer to medical device reports (MDRs), well old timers due. More precisely, (Manufacturer and User Facility Device Experience). MAUDE data contains voluntary reports of adverse events involving medical devices since since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996.

MAUDE Reports Concerning the Accolade Pacemaker

We ran a simple search through the MAUDE database. We pulled for about a year, but our dataset was limited to 500 or so results ranging from December 2024 to late January 2025. You can see the data Accolade MAUDE.

We found over 250 reports with injury event type. We found one death event type listing the device problem as “pacing problem.” The event text reads, “Following implantation of the pacemaker, the patient coded and expired. There was noted to be an absence of pacemaker spikes during the code. The pacemaker was programmed to DDDR mode with a lower rate of 60 beats per minute and an upper rate of 120 beats per minute. It was also reported that the patient had been critically ill. No other information (including identifiable information) was provided.”

We found 10 battery device problems connected to an injury event type. There were others involving a “premature discharge of battery.” Several involved a replacement surgery; meaning, a surgeon removed and replaced the device. That is consistent with our theory of the case. Several other reports concerned explants of the Accolade pacemaker.

Using this dataset, we used a tool to compare the reports against a few reports from FDA and the notice of the Boston Scientific pacemaker recall to identify any rows that match the issues reported in the Boston Scientific Accolade pacemaker recalls. We created a subset spreadsheet of potential related problems. You can check that out Potential Recall Related MAUDE Reports. There were over 120. Notably the death one noted above was included, but we cannot attest to relatedness.

FDA MAUDE Reports Are Not Definitive Evidence of Device Defect or Causation

A cautionary point. Don’t run out looking to get your pacemaker removed. Speak to a healthcare professional; do not rely on this information piece. Moreover, know that FDA explicitly states that MAUDE data may contain errors, incomplete, duplicative, or biased reports because it consists of voluntary and mandatory adverse event reports. The FDA does not verify the reports before publication. As a further disclaimer, the data is self-reported and may not be conclusive. The presence of an adverse event report does not mean a device is faulty or the cause of an injury. We are showing a subset of MAUDE reports. Neither veracity or accuracy, nor causation has not been determined.

Data sourced from the FDA MAUDE database, accessed 2/21/2025.

This is not the first pacemaker recall

The United States Food and Drug Administration (FDA) published three Class I recalls in 2021. As reported in a study of cardiac implantable device recalls: consequences, and management, it is not even the first battery-related pacemaker recall. Four years ago the recalls involved a “subset of St Jude (Abbott) pacemakers, Boston Scientific pacemakers, and Medtronic defibrillators. All these recalls were owing to the risk of premature battery depletion.” The authors concluded that “Given the unpredictable and sudden nature of this St Jude/Abbott recall, it is probably beneficial and advisable to offer affected pacemaker-dependent patients a preemptive generator replacement after engaging in shared decision-making with the affected patient.” We have not seen that here, yet.

Contact KBA Today to Learn More

We are product liability lawyers. When a safety signal emerges, we represent people if the signal reflects a design defect or failure to warn users of known risks. We litigate, try, and settle medical device cases. Our firm has decades of cumulative experience across our medical device attorneys. We had led medical device litigations, tried medical device cases, and operated outside the litigation world within and supporting industry. Our reputation for client-centered service, empathy, and dogged advocacy is why firms refer us cases.

We want to hear from anyone who had an Accolade pacemaker removed. Anyone who had battery problems concerning a Boston Scientific pacemaker should contact us.

Call us at 855-KBA-LAWS (522-5297), complete the form to the right, or email us to learn more, Info@KBAattorneys.com.

Last Updated: February 2025

Disclaimer: This information is for educational purposes only and does not constitute legal or medical advice. Each case is unique and past results do not guarantee future outcomes.