The U.S. Food and Drug Administration (FDA) issued another warning in regards to artery clearing tools. The devices are part of a new system used to open constricted arteries to help blood flow via cutting plaque from artery walls. In September. the FDA reported an incident where a wire piece from the component broke off and punctured a blood vessel, resulting in the patient’s death. Two similar fatalities have also been reported in relation to the defective product. Several additional incidents have prompted emergency surgeries to retrieve dislocated parts. In one surgery the debris was unable to be extracted. Marlborough based Boston Scientific, the product manufacturer, issued a recall on October 9th.
Published reports stated that there were approximately 600 devices on the U.S. market. Boston Scientific spokesman Tom Keppeler, stated the company has alerted 30 U.S. hospitals across seventeen states, including Texas, of the recalled products. Keppeler cited the voluntary recall was “due to the possibility of wire fracture.” He also stated that the company’s standard Rotablator systems, which do not contain the defective parts, are not being a part of the recall. Their alert stated, “The use of affected product may cause serious adverse health consequences, including death.” He said the devices were in “limited distribution and we have contacted all of the affected hospitals accordingly.” This is the company’s third recent recall, a major one being in 2010 for their implantable cardiac defibrillators, and in 2004 for defective heart stents.
If you or someone you know has been injured by a defective medical device, contact an attorney at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling 713-396-3964 or toll free at 800-594-4884.