Which Boston Scientific Pacemaker Models Are Affected by the Recall?

Which Boston Scientific Pacemaker Models Are Affected by the Pacemaker Recall?

The U.S. Food and Drug Administration (FDA) has issued a serious warning about certain Boston Scientific pacemaker models due to a manufacturing defect that may cause these devices to fail. The recall affects a wide range of pacemakers manufactured before September 2018, specifically those within the Accolade family, due to high battery impedance that can trigger the device’s Safety Mode. Once a pacemaker enters this mode, it can no longer regulate the heart’s rhythm properly, putting patients at serious risk.

This issue isn’t minor. These devices are being recalled because they may suddenly lose functionality during normal telemetry or high-power operations-circumstances that can occur during routine medical checks or even while the patient is at home. So far, the FDA has documented hundreds of confirmed device malfunctions, at least two patient deaths, and more than 800 injuries. If you or a loved one has a Boston Scientific pacemaker, it’s critical to check whether your device is one of those affected.

Below, we’ve compiled the official list of recalled models and serial numbers, along with key facts and safety information you need to know if you’re impacted by this recall.

Accolade Pacemaker Recall Models and Serial Numbers

The heart of this recall revolves around devices from the Accolade family. These include a variety of dual chamber and cardiac resynchronization pacemakers designed for both standard and extended battery life. The FDA classified the recall as a Class I event-the most serious level-due to the potential for serious injury or death. Boston Scientific’s advisory identifies models built prior to September 2018 that are at greater risk for Safety Mode activation during telemetry or higher-powered operations.

The following model numbers are part of the Accolade pacemaker recall models list:

• L301 – ACCOLADE DR SL
• L311 – ACCOLADE DR SL MRI
• L321 – ACCOLADE DR EL
• L331 – ACCOLADE DR EL MRI

These devices were distributed nationwide, including to Puerto Rico and U.S. territories, as well as globally. Patients with these devices are urged to contact their cardiologist immediately. The FDA advises monitoring through Boston Scientific’s LATITUDE™ system or in-office visits, especially if the battery life is approaching or below four years.

Full serial number ranges and GTINs are available on the FDA’s website and through Boston Scientific’s Device Lookup Tool.

Other Pacemaker Models in the Affected Group

The recall isn’t limited to the Accolade line. Several other Boston Scientific pacemaker products fall within the same advisory due to shared manufacturing practices and components. These include the Proponent pacemaker affected list, along with other major device groups.

• Proponent DR SL and EL (e.g., L201, L211, L221, L231)
• Essentio DR SL and EL (e.g., L101, L111, L121, L131)
• Altrua 2 DR SL and EL (e.g., S702, S722)
• Visionist CRT-P EL and EL MRI (e.g., U225, U226, U228)
• Valitude CRT-P EL and EL MRI (e.g., U125, U128)

Each of these models shares the risk profile tied to high battery impedance. According to the FDA pacemaker safety alert, approximately 13% of devices manufactured before September 2018 are considered part of the advisory population. The issue stems from battery cathode processing techniques, which may result in a concentration of lithium salts and increased internal resistance, leading to device failure under stress.

If your device falls under one of these model numbers, use the device lookup tool linked above to confirm whether it is included in the recall. Affected individuals should not delay in seeking follow-up care, particularly if symptoms such as fainting, dizziness, or palpitations occur.

Understanding Safety Mode and Its Risks

One of the most alarming aspects of the Boston Scientific pacemaker recall is the risk of the device entering Safety Mode. This is not a programmable or intended treatment setting-it’s a fail-safe backup that kicks in after the pacemaker experiences three internal resets within 48 hours. Unfortunately, once Safety Mode is activated, the pacemaker only provides minimal, unipolar pacing. It stops adapting to the patient’s needs and may no longer prevent bradycardia or regulate heart rhythms effectively.

In Safety Mode, the device is set to fixed parameters: a non-adjustable VVI mode at 72.5 bpm, 5.0 V output, and unipolar sensing. These settings are not tailored to the individual, and for many patients, they offer insufficient support. For those who are pacemaker dependent-meaning their lives rely on the device maintaining proper heart function-this can be catastrophic. In fact, two patient deaths and hundreds of adverse events have already been tied to this condition.

According to the advisory, about 70% of Safety Mode activations have occurred during in-office checks, but many others happened in ambulatory (non-clinical) settings. That means patients may experience critical failures while going about their daily lives. Early replacement is recommended for anyone with a high-risk profile or nearing four years of battery longevity.

If you or someone you care for has an affected pacemaker, you must understand that Safety Mode risk is not theoretical-it is a proven, life-threatening issue that demands urgent attention.

How to Identify If Your Pacemaker Is Affected

Boston Scientific has provided multiple ways to identify whether your device is part of the recall. Every pacemaker has a model number and serial number, which are typically recorded in your medical records or available through your cardiologist. Patients and providers can use the Boston Scientific Device Lookup Tool to enter these details and receive confirmation on whether the pacemaker is affected.

Additionally, the FDA and Boston Scientific have published full lists of Boston Scientific device serial numbers and model identifiers. These include:

• ACCOLADE models L301, L311, L321, L331
• PROPONENT models L201, L209, L211, L221, L231
• ESSENTIO models L101, L111, L121, L131
• ALTRUA 2 models S702, S722
• VISIONIST CRT-P models U225, U226, U228
• VALITUDE CRT-P models U125, U128

Each model has multiple GTINs and serial ranges, and you can check whether a specific combination is part of the advisory. The FDA’s Enforcement Report lists these devices under Recall Event ID 95969. You can also consult your physician or Boston Scientific directly if you cannot find your device information.

Accurate identification is the first step toward managing this issue. If you’re unsure, don’t guess-verify. The sooner you know whether your device is compromised, the sooner you can take appropriate action.

What to Do If You Have a Recalled Device

If you’ve confirmed that your pacemaker is among the affected devices, don’t panic-but don’t wait. The FDA recommends patients continue regular follow-up care, either through in-office visits or remote monitoring via Boston Scientific’s LATITUDE system. This monitoring can detect signs that the device may be failing or has entered Safety Mode.

Discuss your pacing dependency and battery longevity with your doctor. If your device has fewer than four years of battery life remaining-or you are highly dependent on consistent pacing-you may need to schedule a replacement procedure. For some patients, device replacement will be urgent. For others, it may be scheduled non-emergently but still well before a problem arises.

It’s important to note that battery life estimations may no longer be accurate once a device enters Safety Mode, due to higher energy demands. The FDA has made clear that patients should not rely solely on battery indicators to assess urgency. Your doctor can help evaluate your risks and determine the right timeline for action.

In some cases, Boston Scientific recommends disabling certain features like patient-initiated interrogation (PII) to reduce the chance of triggering Safety Mode. Follow-up intervals may also be shortened to quarterly rather than annual check-ins.

Complications and Legal Ramifications for Affected Patients

The human cost of this recall is not theoretical. More than 800 injuries and at least two confirmed deaths have already been linked to this failure. Patients have reported bradycardia, fainting spells, and in some cases, total loss of pacing support. The risk escalates for those who are dependent on their pacemakers to manage severe arrhythmias or heart failure.

We’ve heard from individuals who experienced sudden device failure while driving, at work, or at home-leading to falls, injury, and hospitalizations. For example, one patient with an affected Accolade EL MRI model began experiencing dizziness and lightheadedness. When evaluated, their pacemaker was found to have entered Safety Mode, forcing an emergency replacement. Another case involved a patient whose device failed during routine interrogation at a clinic, leading to unresponsiveness and hospitalization.

If you or a loved one has suffered harm due to a Boston Scientific pacemaker failure, you may be entitled to compensation. The failure of a medical device-especially one implanted in your body to sustain life-raises serious concerns about product safety, oversight, and accountability. You should not bear the burden of medical costs, pain, or suffering alone.

Our firm is reviewing cases involving patients affected by this recall. We can help you determine whether you have a legal claim, and what options are available to pursue compensation for your injuries, treatment expenses, and emotional distress.

Call Our Firm If You Have a Recalled Boston Scientific Pacemaker

If you or a loved one has one of the recalled Boston Scientific pacemaker models, do not delay in taking action. These devices pose serious risks, and it is critical to act quickly to confirm whether your pacemaker is affected and what steps should be taken to protect your health.

Our lawyers at Alonso Krangle, LLP are actively investigating claims related to this FDA recall. We are available to review your case, answer your questions, and help you navigate the steps ahead. Whether you need guidance on how to verify your device, assistance arranging medical review, or help pursuing a legal claim, we’re here for you.

Contact us at [PHONE] or use the contact form on this page to schedule a free, confidential consultation. Your health and safety are too important to ignore. If you have one of the affected models, let our firm help you take the next step forward.