Patients Face Serious Health Risks After Using the Varipulse Catheter System
The U.S. Food and Drug Administration (FDA) has issued a Class I recall—the most serious type of recall—for the ablation catheters used in Johnson & Johnson MedTech’s Varipulse pulsed field ablation (PFA) system. While the recall does not require returning or removing devices from the market, the FDA has urged all healthcare providers to review updated instructions provided by the manufacturer. The recall was prompted by reports that approximately 3% of patients treated with the Varipulse system suffered a stroke or transient ischemic attack (TIA) shortly after their procedure, a rate significantly higher than the expected 1%.
This recall follows Johnson & Johnson MedTech’s decision to pause the U.S. rollout of the Varipulse system in early January before resuming it nearly six weeks later. The decision to continue using the device has raised concerns among medical professionals and patients, as four serious injuries have already been linked to its use. The FDA’s classification of the recall underscores the severity of the risks, warning that patients could suffer serious injury or death if the device is used without reviewing updated safety protocols.
Johnson & Johnson MedTech has issued specific recommendations to healthcare providers to mitigate the risks associated with the Varipulse PFA system. Physicians are advised to carefully review the company’s investigation into the reported strokes, share this information with patients when determining whether the treatment is appropriate, and ensure their facilities are aware of these safety concerns. Additionally, a post-approval study is planned to further assess the long-term benefits and risks of the device.
The Varipulse PFA system received FDA approval in November 2024, following a clinical trial involving 277 patients across the United States. The study reported a 100% acute procedural success rate and a 75% primary effectiveness rate, making the device appear promising at the time of approval. However, the unexpected increase in stroke risk among early U.S. patients raises serious questions about whether the device was adequately tested before being released to the market.
The Potential Dangers of the Varipulse PFA System
Patients undergoing catheter-based ablation procedures already face known risks, but the increased stroke rate associated with the Varipulse system suggests a specific defect or procedural issue that may be making the device more dangerous than others. Strokes and transient ischemic attacks occur when blood flow to the brain is disrupted, which can lead to brain damage, disability, or death. In a best-case scenario, a TIA results in temporary symptoms, but full recovery is never guaranteed.
For those who suffered a stroke after a Varipulse procedure, the consequences can be life-altering. Brain damage from a stroke can lead to permanent loss of motor function, speech impairment, cognitive decline, or even complete loss of independence. Patients may require extensive medical treatment, rehabilitation, and long-term care, placing a financial and emotional burden on their families. In cases where the stroke is fatal, surviving family members must deal with an unimaginable loss while facing medical bills and funeral expenses.
Legal Options for Patients Harmed by the Varipulse System
Patients who suffered a stroke or other severe complications after undergoing a procedure with the Varipulse PFA system may have grounds to file a product liability lawsuit against Johnson & Johnson MedTech. Manufacturers of medical devices are legally obligated to ensure their products are safe before they reach the market. When a device causes unexpected harm, victims have the right to seek compensation for their injuries and losses.
A product liability lawsuit against Johnson & Johnson MedTech would focus on whether the company failed to properly test the Varipulse system before releasing it, whether they failed to warn doctors and patients about the increased risk of stroke, and whether they were negligent in continuing to sell the device after serious injuries were reported. Plaintiffs would need to provide medical records, expert testimony, and other evidence linking their stroke to the use of the Varipulse system.
The Legal Process and Why Victims Need an Attorney
Filing a product liability lawsuit against a major medical device manufacturer can be a complex process, requiring extensive legal and medical knowledge. Victims must first establish that they suffered harm as a direct result of the Varipulse system. This involves gathering medical records, expert opinions, and possibly even witness testimony from healthcare providers.
Once a lawsuit is filed, both sides will enter the discovery phase, where evidence is exchanged. This can include internal documents from Johnson & Johnson MedTech that may reveal whether the company was aware of the increased stroke risk before the recall. Many cases are resolved through settlements, but if a fair agreement cannot be reached, the case may proceed to trial.
Victims of defective medical devices need an attorney at every stage of the process. Corporations like Johnson & Johnson MedTech have legal teams dedicated to minimizing payouts and avoiding liability. Without representation, victims may be pressured into accepting settlements that do not cover the full extent of their medical expenses, lost wages, and future care needs. An attorney ensures that victims have a fair chance to recover the compensation they deserve.
Potential Compensation for Victims
Patients who suffered a stroke or TIA after a Varipulse procedure may be eligible for compensation covering a wide range of damages. Medical expenses, including emergency treatment, rehabilitation, and long-term care, can be recovered through a lawsuit. Lost wages and loss of earning capacity may also be included, especially if the stroke resulted in a permanent disability that prevents the victim from working.
Pain and suffering damages can account for the physical and emotional trauma caused by the stroke. Victims who have lost their independence or suffered a diminished quality of life due to their injuries may receive compensation for these hardships. In cases where the stroke was fatal, the victim’s family may pursue a wrongful death claim to recover damages for funeral costs, loss of companionship, and financial support.
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