Accolade, Proponent, Essentio, Altrua 2, Visionist, and Valitude Cardiac Resynchronization Therapy Pacemakers May Require Surgical Replacement
Boston Scientific has recalled a subset of Accolade pacemakers after discovering a malfunction that could cause devices to enter safety mode permanently, limiting their ability to regulate heartbeats. The recall, now classified as a Class I event by the Food and Drug Administration (FDA), the most serious type of recall, has been tied to 832 injuries and two deaths. This defect poses a life-threatening risk to patients who depend on these devices to maintain a normal heart rhythm, as a pacemaker stuck in safety mode may not provide the necessary electrical stimulation to keep the heart beating properly.
The recall applies to multiple models within the Accolade family of pacemakers, including Accolade, Proponent, Essentio, Altrua 2, Visionist, and Valitude cardiac resynchronization therapy pacemakers. Boston Scientific first notified customers of the safety risks in December 2024, but the exact number of affected devices was not disclosed at that time. The company has since confirmed that approximately 203,000 devices worldwide were manufactured before September 2018 and could be at risk.
The malfunction occurs when the pacemaker’s battery underpowers the system due to a manufacturing issue, triggering a permanent shift into safety mode. While the safety mode is designed to prevent complete device failure, it limits the pacemaker’s ability to regulate heart rhythms effectively, which could result in serious complications, including heart failure or sudden cardiac events. Patients and physicians can only detect whether a device has entered safety mode through remote monitoring or in-office visits, making routine check-ups essential.
The FDA recommends that patients consult their doctors immediately to establish a monitoring plan and determine whether device replacement is necessary. While remote monitoring can provide alerts if a pacemaker enters safety mode, some patients may not have access to this technology, requiring them to schedule regular in-office visits. In cases where a pacemaker is found to be in safety mode, surgery is the only option to replace the defective device, adding further health risks and financial burdens for patients.
The Serious Health Risks Posed by Defective Pacemakers
Pacemakers are critical medical devices that regulate abnormal heart rhythms and prevent life-threatening cardiac conditions. When a pacemaker fails, patients may experience dizziness, fainting, shortness of breath, and even heart failure. In extreme cases, sudden cardiac arrest can occur, leading to fatal consequences. The Accolade pacemaker recall highlights how dangerous medical device malfunctions can be, particularly when a defect affects the device’s ability to perform its intended function.
Patients who rely on these devices to sustain their health now face uncertainty about whether their pacemaker is functioning properly. The need for surgical removal and replacement presents additional dangers, particularly for elderly patients or those with preexisting conditions that make surgery more hazardous. Even for those who can safely undergo a pacemaker replacement, the risks of infection, complications during surgery, and long recovery periods cannot be ignored.
Beyond the immediate physical dangers, patients dealing with defective pacemakers may experience significant emotional distress. The fear of sudden pacemaker failure can create anxiety and impact daily life, leaving individuals unable to engage in normal activities without constant worry. The financial burden of unexpected medical procedures further compounds the stress, particularly for those without comprehensive health insurance coverage.
Filing a Lawsuit for Injuries Caused by Defective Pacemakers
Patients harmed by a defective Boston Scientific pacemaker may have grounds to file a product liability lawsuit against the manufacturer. Medical device manufacturers have a legal responsibility to ensure that their products are safe and effective before they reach the market. When a defect causes injuries or deaths, victims can seek compensation for their losses.
A product liability claim against Boston Scientific would focus on the design and manufacturing defect that caused the pacemakers to enter safety mode prematurely. The lawsuit may also argue that the company failed to warn patients and doctors adequately about the risks associated with these devices. Since the issue stems from a battery malfunction, attorneys representing injured patients will likely investigate whether Boston Scientific knew about the defect and continued selling the pacemakers despite the risks.
Victims pursuing legal action will need to establish that their injuries were directly caused by the defective pacemaker. This typically requires medical records, expert testimony, and evidence showing that the device failed to function as intended. Those who had to undergo surgery to replace a malfunctioning pacemaker may also need to provide proof of the procedure and associated costs.
Why Legal Representation is Necessary for Product Liability Claims
Filing a lawsuit against a major medical device manufacturer is a complex process. Boston Scientific will likely have a team of attorneys working to defend against claims, making it difficult for individuals to secure fair compensation on their own. An attorney with experience handling medical device lawsuits can guide patients through the legal process, ensuring that their case is properly documented and supported by the necessary evidence.
Medical device litigation often involves technical details that require extensive research and expert testimony. Lawyers handling these cases will work with medical professionals to demonstrate how the defect caused harm and whether Boston Scientific failed to take proper precautions to prevent the issue. Additionally, an attorney can help victims calculate the full extent of their damages, including medical expenses, lost wages due to recovery time, and pain and suffering.
Negotiating with large corporations and their insurers can be challenging, as they often attempt to minimize payouts or deny claims outright. Having legal representation can ensure that victims receive fair compensation for their injuries. If necessary, an attorney can take the case to trial and present compelling evidence to hold Boston Scientific accountable.
Compensation Available in a Product Liability Lawsuit
Patients affected by defective Boston Scientific pacemakers may be entitled to compensation for various damages. These can include medical expenses related to pacemaker removal and replacement surgery, as well as ongoing treatment costs for complications resulting from the malfunction. If a victim was unable to work due to their injuries or recovery process, they may also seek compensation for lost wages.
Pain and suffering damages can account for the physical pain and emotional distress caused by living with a defective medical device. Anxiety over the possibility of pacemaker failure, the trauma of undergoing surgery, and the impact on daily life all contribute to the overall harm suffered by victims.
In cases where the defective pacemaker led to fatal injuries, the surviving family members of the deceased may file a wrongful death lawsuit. This type of claim can provide compensation for funeral expenses, loss of financial support, and the emotional toll of losing a loved one. Punitive damages may also be pursued if it can be proven that Boston Scientific was aware of the defect but failed to take proper action to prevent harm.
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