FDA Issues Safety Warning on Atherectomy Devices Following Reports of Serious Injuries and Deaths
The U.S. Food and Drug Administration (FDA) has issued an urgent safety warning regarding Bard Peripheral Vascular’s Rotarex Atherectomy System, a medical device used to remove plaque and blood clots from peripheral arteries. The device, manufactured by the Arizona-based subsidiary of Becton, Dickinson and Company (BD), has been linked to serious complications, including device breakage inside the body. According to the FDA, the device's rotating helix can fracture or break due to stress, wear, high temperatures, friction, or localized pressure during use. These failures can result in severe bleeding, vascular damage, and even death.
The FDA’s warning follows reports of over 100 incidents, including 30 serious injuries and four deaths attributed to the malfunctioning device. Although the agency has not yet classified this as a recall, it has issued an early alert to healthcare providers and patients to ensure that the risks associated with the device are widely known.
The Risks Associated with the Rotarex Atherectomy System
Atherectomy devices like the Rotarex system are designed to remove blockages from blood vessels using a high-speed rotating mechanism. These devices are commonly used in patients with peripheral artery disease (PAD), a condition that restricts blood flow due to plaque buildup in the arteries. While the procedure can be effective in restoring circulation, the design flaws in the Rotarex system have raised significant safety concerns.
The FDA has indicated that under specific conditions, the device’s helix can fracture or break during use, leading to dangerous complications. If a broken piece of the catheter remains inside a blood vessel, it can cause vessel injury, significant bleeding, or even total vessel blockage. In cases where fragments dislodge and travel through the bloodstream, patients may face life-threatening complications, including stroke, embolism, or organ damage.
The manufacturer, Bard Peripheral Vascular, has released new guidelines to address the risks, urging physicians to use kink-resistant sheaths, maintain constant catheter movement, and avoid using the device in specific anatomical conditions. Despite these measures, the potential for device failure remains a serious concern for both medical professionals and patients undergoing atherectomy procedures.
How Defective Medical Devices Harm Patients
Patients who undergo atherectomy procedures expect their medical devices to function as intended. However, when a device malfunctions, the consequences can be devastating. The risks associated with a fractured or broken atherectomy device go beyond immediate medical emergencies. Patients who experience complications from the Rotarex system may require additional surgeries to retrieve broken fragments, repair vascular injuries, or address secondary complications such as infections or organ damage. These procedures can be invasive, costly, and physically exhausting.
Beyond the physical harm, defective medical devices can also lead to significant emotional and financial distress. Many patients suffer prolonged pain and extended recovery periods, preventing them from returning to work or resuming normal daily activities. The added financial burden of unexpected medical expenses can place families under immense stress, especially when insurance does not fully cover the costs associated with revision surgeries and extended hospital stays.
When patients are harmed due to a defective medical device, they have the right to seek legal action against the manufacturer. Medical device companies are responsible for ensuring the safety of their products before they are released to the public. When they fail to do so, and patients suffer as a result, legal claims may provide a path to financial compensation and accountability.
Filing a Lawsuit for Atherectomy Device Injuries
Victims who have suffered injuries due to the Bard Peripheral Vascular Rotarex Atherectomy System may have grounds to file a product liability lawsuit against the manufacturer. These claims typically fall under three main legal theories:
- Defective Design: If the device’s fundamental design makes it prone to breaking, the manufacturer can be held liable for distributing a product that was not reasonably safe for its intended use.
- Manufacturing Defect: If errors during the production process resulted in weak or faulty components, the company can be held responsible for failing to meet safety standards.
- Failure to Warn: If the manufacturer did not provide adequate warnings about the risks associated with using the device, they could be liable for not informing doctors and patients of potential dangers.
Filing a product liability lawsuit involves several steps, starting with gathering evidence to prove the device’s failure directly caused harm. This includes medical records, surgical reports, expert analysis, and any communication with the manufacturer regarding the device’s risks. Once a lawsuit is filed, both sides engage in discovery, where evidence is exchanged. Many cases settle before trial, but if a fair resolution cannot be reached, the case may proceed to court.
Why Victims Need an Attorney for a Defective Medical Device Case
Product liability cases involving defective medical devices are highly complex. Manufacturers often have legal teams dedicated to defending against these claims, making it difficult for victims to secure fair compensation without legal representation. An attorney plays a critical role in proving liability, negotiating settlements, and advocating for victims in court when necessary.
A skilled product liability lawyer will work with medical professionals and engineers to establish the link between the defective device and the patient’s injuries. They will also ensure that all relevant medical costs, lost wages, and long-term damages are factored into the claim. Without experienced legal guidance, victims may struggle to recover the full compensation they deserve.
Damages Victims Can Recover in a Product Liability Lawsuit
Patients injured by the Rotarex Atherectomy System may be entitled to various types of damages in a lawsuit. These can include:
- Medical Expenses: Coverage for surgeries, hospital stays, rehabilitation, and ongoing treatments related to device-related injuries.
- Lost Income: Compensation for wages lost due to extended recovery or disability caused by the defective device.
- Pain and Suffering: Monetary compensation for physical pain, emotional distress, and reduced quality of life.
- Wrongful Death: Families of patients who died due to device failure may seek compensation for funeral costs, loss of financial support, and emotional suffering.
- Punitive Damages: If the manufacturer is found to have acted recklessly by failing to address known safety risks, additional damages may be awarded to deter future negligence.
If you or a loved one have suffered injuries due to a defective atherectomy device, legal action may be necessary to secure compensation for medical expenses, lost income, and pain and suffering. The national product injury law firm Parker Waichman LLP is committed to holding medical device manufacturers accountable and fighting for justice on behalf of injured patients.
Contact Parker Waichman LLP For a Free Case Review
Contact us by calling 1-800-YOUR-LAWYER (1-800-968-7529) today for a free consultation and find out how our legal team can help you pursue the compensation you deserve. Regardless of where your injury occurred, our national product injury law firm is ready to assist you.
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