A Class I recall has been issued for two defective 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. The Lawrence 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. Contact our firm today to discuss your potential claim with an experienced attorney by calling 800-698-4054 or sending us an email at [email protected].