A Class I recall has been issued for two defective devices: cardiac guidewire devices. The Rotawire Elite and wireClip Torquer, manufactured by Boston Scientific, have been pulled from the market after being linked to serious complications, including death. TLF: The Medical Injury Law Firm is currently accepting clients who have been injured, or who have lost loved ones as a result of these defective devices.
The Rotablator Rotational Atherectomy System consisted of a diamond tipped burr capable of high speed rotation designed for breaking up and removing plaque. The system is used to treat a condition called atherosclerosis, a disease in which plaque builds up inside of arteries. In order to improve blood flow to the heart, cardiac surgeons use guidewire devices to navigate vessels, and the diamond-tipped burr then travels along the guidewire to where the plaque was built up. The Rotawire Elite and wireClip Torquer Guidewire Manipulation devices were two parts of this system.
On October 9, 2015, Boston Scientific issued a Class I recall for its RotaWire Elite and wireClip Torquer. The recall came after reports of the devices cracking and separating from the rest of the system, which caused tamponade (blood in the sac around the heart causing decreased heart function), heart attack, and damage to other vessels in the event of migration. In total, 955 devices that had been distributed in 17 different states were pulled from the market. Class I recalls are the most serious type of recall and are only issued when there is a significant risk that the use of the product will result in serious injury or death. Although the recall only involved the two specific devices, the safety of other guidewire devices has since come into question.
If you or a loved one underwent surgery involving cardiac guidewire systems and experienced serious symptoms or death as a result, you may be able to receive compensation. Whether you or a loved one were a victim of hospital negligence, surgical errors, medication errors, anesthesia errors, or doctor negligence, seeking compensation is your legal right. Knowing how to exercise your rights in Kentucky can help you to get started on the road to financial relief. If you or a loved one received injuries due to the negligence of a medical professional, reach out to one of the Kentucky medical malpractice lawyers at our Covington law firm, TLF: The Medical Injury Firm, today.