Boston Scientific ENDOTAK RELIANCE Defibrillation Lead Lawsuit Lawyers

Boston Scientific ENDOTAK RELIANCE Defibrillation Lead Alert: Patient Risks, Injuries, and Legal Options

The recent FDA Early Alert concerning Boston Scientific’s ENDOTAK RELIANCE defibrillation leads has raised serious concerns among patients, families, and healthcare providers nationwide. These implanted cardiac devices are intended to save lives by delivering life-saving shocks during dangerous heart rhythms. However, a defect involving calcification of the lead coils may impair shock delivery, reduce treatment effectiveness, and increase the risk of death during a cardiac emergency.

Boston Scientific’s own investigation revealed troubling findings: certain leads coated with expanded polytetrafluoroethylene (ePTFE) are more prone to coil calcification, leading to a gradual rise in electrical resistance (low-voltage shock impedance). Over time, this can compromise the ability to restore normal heart rhythm when it’s most needed. The company has linked this defect to 386 serious injuries and 16 patient deaths.

For affected patients, this is more than a technical malfunction—it is a deeply personal issue that may involve traumatic events, emergency surgeries, and long-term health consequences. Victims and families need to understand the risks, the scope of the problem, and their legal rights to hold manufacturers accountable.

Understanding the Defibrillation Lead Defect

Defibrillation leads are insulated wires that connect the heart to an implantable cardioverter-defibrillator (ICD). The lead’s coils deliver electrical energy to the heart during a life-threatening arrhythmia. In the affected Boston Scientific models, the ePTFE-coated coils may develop calcification over time.

This calcification is not just a cosmetic change—it biologically encapsulates the coil, reducing electrical conductivity. As a result, when the ICD delivers a shock, the energy may not reach the heart at the necessary level to restore normal rhythm.

The defect can remain undetected for years, as the device may appear to function normally during routine monitoring. By the time rising impedance is detected, the patient may already be at risk for a failed life-saving intervention. Some patients have required premature lead replacement, which carries its own risks, including infection, damage to blood vessels, or even death during extraction.

Documented Injuries and Deaths

Boston Scientific’s records indicate at least 16 patient deaths and 386 serious injuries linked to this defect. These numbers are particularly alarming given the high-risk nature of the patient population—individuals already living with serious cardiac conditions.

Injuries include:

• Failure of the ICD to convert a dangerous arrhythmia to a normal rhythm.
• Cardiac arrest requiring external resuscitation.
• Emergency surgical interventions to replace the defective lead.
• Complications from lead extraction, such as vascular tears or infections.

For many patients, this has meant unexpected hospitalizations, emotional trauma, and long-term physical impairment

FDA Involvement and Manufacturer Response

The FDA has issued an Early Alert to notify the public and healthcare providers of this potential hazard. Boston Scientific sent letters to physicians urging continued monitoring, remote surveillance, and careful risk-benefit analysis before extracting defective leads.

The company acknowledges that lead replacement is often necessary but warns of significant surgical risks. The advice to “abandon” defective leads instead of removing them in some cases means that patients may carry a known faulty device indefinitely, relying on a replacement lead while the defective one remains in place.

Despite these measures, patients and families may question why the defect was not addressed sooner, especially given the potentially fatal consequences.

Legal Rights for Injured Patients and Families

Medical device manufacturers are legally obligated to ensure their products are safe for their intended use. When a device fails and causes harm, injured patients have the right to seek compensation for medical expenses, lost income, pain and suffering, and wrongful death in fatal cases.

Possible legal claims include:

• Product liability for manufacturing or design defects.
• Failure to warn of known or foreseeable risks.
• Negligence in testing, monitoring, or recalling defective devices.

These claims require prompt legal action. Time limits for filing lawsuits (statutes of limitations) vary by state, and waiting too long could jeopardize a victim’s ability to recover compensation.

Boston Scientific Medical Device Lawsuit FAQs

1. What is the main problem with the Boston Scientific ENDOTAK RELIANCE leads?
   The primary issue is calcification of the ePTFE-coated shock coils, which increases electrical resistance and may reduce the device’s ability to deliver effective shocks during a cardiac emergency.
2. How do I know if I have one of the affected leads?
   Patients should review their implant records or contact their cardiologist to confirm the lead model and serial number. The affected models include multiple versions of ENDOTAK RELIANCE, RELIANCE 4-SITE, and RELIANCE 4-FRONT leads listed in the FDA’s alert.
3. What symptoms might indicate a problem?
   The defect may not produce noticeable symptoms until the device fails to deliver an effective shock. Some patients may experience fainting, dizziness, palpitations, or cardiac arrest during an arrhythmia episode.
4. What should I do if I have an affected lead?
   Do not panic or stop using your ICD. Schedule an appointment with your cardiologist to discuss monitoring and potential replacement options. Document all communications with your healthcare team.
5. Are there risks in replacing the defective lead?
   Yes. Lead extraction carries risks such as bleeding, infection, or damage to the heart or blood vessels. Your doctor will weigh these risks against the danger of keeping the defective lead in place.
6. Can I file a lawsuit if I have not been injured yet?
   In some states, patients may pursue claims for medical monitoring or preventive replacement costs, but laws vary. A product liability attorney can review your situation and explain your legal options.
7. What compensation could be available?
   Damages may include medical costs, lost wages, pain and suffering, and, in fatal cases, funeral expenses and loss of companionship.
8. Why contact a national law firm?
   A national firm like Parker Waichman LLP has the resources to handle complex medical device litigation across state lines, including access to medical experts and a proven track record in defective device cases.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one has a Boston Scientific ENDOTAK RELIANCE defibrillation lead and experienced complications, you may be entitled to significant compensation. The risks from this defect are serious, and legal deadlines apply. Parker Waichman LLP is a national personal injury law firm with extensive experience handling defective medical device claims. We will fight to hold manufacturers accountable and seek justice for injured patients and grieving families.

Call 1-800-YOUR-LAWYER (1-800-968-7529) for a free, no-obligation consultation today. Regardless of your location or where your injury occurred, our nationwide medical device injury law firm is ready to assist you and provide you with a free consultation.