Medtronic HawkOne Lawsuit
The U.S. Food and Drug Administration (FDA) issued a Class 1 recall for medtech giant Medtronic’s HawkOne Directional Atherectomy System on January 21, 2022. The FDA recalled more than 95,000 HawkOne devices that were distributed across the country starting back in 2018.
The HawkOne system is designed to unclog peripheral arteries. It uses a catheter and a cutter driver that spins at up to 12,000 RPM to remove plaque from inside peripheral arteries and improve blood flow.
The FDA recalled the device because a defect with the system’s guidewire can cause the wire to prolapse or bend downward when force is applied. This can sever the tip of the catheter, causing it to break off inside the body and leading to potentially life-threatening complications, including arterial rupture, reduced blood flow to a portion of the body due to blockage, and damage to blood vessels. Surgical intervention might be required to repair any internal damage and remove the severed catheter tip.
At the time of the recall, the FDA had received 163 complaints regarding the HawkOne device. Although no deaths have yet been reported, 55 individuals reported injuries.
This is not the first time Medtronic has faced a Class 1 FDA recall, the most serious type. In fact, the company’s Puritan Bennett ventilators and StealthStation neurosurgery software were also subjected to recall recently. The company has also had issues with other products it manufactured, including HeartWare blood pumps and its HVAD implant kits.
If you or someone you love suffered injuries that occurred after treatment that included the use of a Medtronic HawkOne Directional Atherectomy System, you could be entitled to take legal action against Medtronic. Manufacturers who produce defective medical devices or fail to disclose information about the dangers of using a certain device can be held liable for damages in civil court.
Through a product liability claim, you might be able to obtain compensation for medical expenses, lost income during your recovery period, pain and suffering, and other damages you suffered due to Medtronic’s negligence. You deserve a chance to hold the at-fault party accountable for their misconduct.
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Farris, Riley & Pitt, LLP is a full-service personal injury law firm based in Birmingham, Alabama. Our team has over 20 years of experience helping injured victims recover compensation in the Birmingham area. We handle a wide variety of personal injury cases in addition to defective products, including medical malpractice, car accidents, slip and fall accidents, and wrongful death. We have been recognized by prestigious organizations such as National Trial Lawyers and Super Lawyers, and are committed to fighting for individuals and families here in Alabama.
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Contact the Birmingham mass tort attorneys of Farris, Riley & Pitt, LLP today to discuss your case and evaluate your legal options. We would be happy to discuss a possible claim with you during a free initial consultation.
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