Boston Scientific Defibrillator Lead Injury & Wrongful Death Lawsuit Attorneys

Boston Scientific Defibrillator Lead Recall Raises Alarms Over Shock Failures and Fatal Cardiac Events

Thousands of patients across the United States rely on implantable cardioverter defibrillators (ICDs) to prevent sudden cardiac arrest. These devices are designed to detect life-threatening arrhythmias and deliver a lifesaving shock. When functioning properly, they can prevent fatal heart events. However, recent updates from the U.S. Food and Drug Administration (FDA) reveal serious safety issues tied to certain Boston Scientific defibrillator leads, which connect the ICD to the heart.

The FDA has now confirmed that these faulty components are subject to Class I recalls, the agency’s most serious level, indicating that continued use could cause severe injury or death. As of July 2025, the malfunction has been linked to 386 injuries and 16 deaths. Patients and families affected by these leads may have grounds to pursue legal claims for medical harm caused by these devices.

What Are Defibrillator Leads and How Do They Work?

Implantable defibrillators rely on thin, insulated wires known as leads to detect the heart’s electrical activity and deliver corrective shocks. These leads are surgically implanted into the heart’s chambers and connected to a defibrillator implanted in the chest.

Boston Scientific’s Endotak Reliance, Reliance 4-SiteFront, and Reliance 4-Front leads are widely used models designed for:

• Rate-sensing
• Pacing
• Delivering cardioversion or defibrillation shocks

These leads are typically coated with expanded polytetrafluoroethylene (ePTFE), a material used to insulate and protect the leads within the body.

The Defect – What Is Low-Voltage Shock Impedance?

The FDA’s recall concerns rising low-voltage shock impedance (LVSI) in leads coated with ePTFE. Impedance is a measure of electrical resistance. As impedance increases, the defibrillator’s ability to deliver effective shocks declines.

When LVSI rises significantly, the defibrillator may fail to convert a life-threatening arrhythmia into a normal rhythm. The consequences of a failed shock can include:

• Prolonged ventricular arrhythmia
• Cardiac arrest
• Death
• Need for external resuscitation

Boston Scientific warns that early warning signs may not always appear. Some patients may undergo emergency lead replacement without prior symptoms, while others may suffer cardiac emergencies due to ineffective shock delivery.

Scope and Timeline of the Recall

The impacted defibrillator leads were manufactured between 2002 and 2021, meaning tens of thousands of individuals may still have these devices in use. The FDA first notified the public about rising impedance concerns in August 2025, based on data submitted by Boston Scientific.

Now, as of September 2025, the FDA has formally classified the situation as a Class I recall after confirming the dangers posed by these leads. The decision was made after reviewing nearly 400 adverse event reports, including 16 deaths and 386 serious injuries.

Importantly, this recall does not mandate product removal from the market. Instead, it requires specific monitoring and action plans to prevent further harm.

What Healthcare Providers Are Being Told to Do

Boston Scientific has issued new safety instructions to all clinicians and hospitals treating patients with the affected defibrillator leads. These instructions include:

• Monitoring lead impedance closely during routine check-ups
• Replacing any leads where impedance exceeds 150 ohms, which may signal a malfunction
• Avoiding unnecessary extraction due to calcification risks in long-implanted leads

Extracting old leads can be risky, especially if the device has been in place for years. Scar tissue and calcification increase the chance of severe complications during removal. For some patients, clinicians may decide to leave the faulty lead in place and implant a new one alongside it — a process known as lead abandonment.

Risks to Patients with Faulty Leads

Patients with these leads face serious health threats. If a defibrillator fails to shock during a cardiac event, the results can be deadly. In less severe scenarios, patients may experience:

• Fatigue or shortness of breath from untreated arrhythmias
• Fainting or loss of consciousness
• Psychological distress
• Invasive surgeries to replace malfunctioning leads

In some cases, the problem may only be discovered after a cardiac emergency, when it’s too late to prevent harm. Boston Scientific and the FDA stress the importance of proactive monitoring.

Legal Rights of Patients and Families

Individuals who suffered harm or lost loved ones due to malfunctioning Boston Scientific leads may have strong legal claims. Defective medical device lawsuits often fall under one or more of the following categories:

• Product Liability: Holding the manufacturer accountable for producing or distributing a dangerous device.
• Failure to Warn: Alleging that Boston Scientific did not sufficiently warn the public or healthcare providers of known risks.
• Wrongful Death: Allowing surviving family members to seek compensation after a fatal malfunction.

Damages can include:

• Medical expenses for emergency care and lead replacement
• Loss of future income
• Funeral expenses
• Pain and suffering
• Emotional distress and trauma

Why Legal Representation Matters

Cases involving defective implantable medical devices are complex. They require a detailed investigation of:

• Device batch numbers and manufacturing dates
• Patient medical records
• Communications from Boston Scientific to hospitals and doctors
• FDA reports and recall documentation

A national personal injury law firm with experience handling product recalls can coordinate expert medical review, navigate federal regulations, and pursue justice through the courts. Victims should act promptly to protect their legal rights and explore financial compensation for what they have endured.

Boston Scientific Defibrillator Lead Lawsuit FAQs

What devices are included in the FDA’s recall?

The recall involves Boston Scientific’s Endotak Reliance, Reliance 4-SiteFront, and Reliance 4-Front defibrillation leads coated with ePTFE. These leads were manufactured between 2002 and 2021.

What is a Class I recall?

A Class I recall is the FDA’s most serious category, used when there is a high risk of injury or death. It means the product has already caused harm and presents a continuing danger if used.

How can I find out if I have one of the recalled leads?

Patients should contact their cardiologist or device clinic. Medical records, implant cards, or the device’s model number can help confirm whether the affected leads are in use.

What is impedance, and why does it matter?

Impedance measures electrical resistance. If it rises too high, the defibrillator may not deliver a strong enough shock during a cardiac emergency, potentially resulting in a failed lifesaving intervention.

Do I need to have my leads removed immediately?

Not necessarily. Removal decisions depend on individual circumstances. Some patients may benefit from close monitoring, while others may require lead replacement. Any decision should be made by a cardiologist familiar with the device and patient history.

Can I file a lawsuit if I’ve been harmed by one of these leads?

Yes. If you experienced medical complications, shock failure, cardiac arrest, or lead replacement surgery due to one of these devices, you may be eligible for legal compensation.

What if a loved one died because of a defibrillator malfunction?

Families may have grounds for a wrongful death lawsuit if the death was linked to a malfunctioning Boston Scientific lead. Legal claims can cover financial losses, funeral expenses, and emotional trauma.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one experienced complications, shock failure, emergency surgery, or death due to a malfunctioning Boston Scientific defibrillator lead, you may be entitled to financial compensation. Parker Waichman LLP is a national personal injury law firm investigating cases involving FDA-recalled medical devices.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today to schedule a free, no-obligation consultation. Our legal team will review your case and help you take the next steps to seek justice and compensation. Don’t wait—time limits may apply to your claim. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.