Nearly 15,000 Americans are facing a potential nightmare: a recall on a medical device placed in their hearts. The Guidewire, manufactured by Medtronic (one of the largest device makers in the world), was voluntarily recalled by the medical device manufacturer, after several patients reported complications. The FDA has categorized it as a Class I recall.
The FDA defines a Class I recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” To date, only four adverse instances have been reported, and Medtronics (which has an office in NJ) claims to have fixed the problems with the initial Guidewires.
A Guidewire is a medical device used to help doctors place other medical devices within the heart. It can be used to place stents in blocked arteries or to set a pacemaker in place. The thin wires are coated with a material called polytetrafluoroethylene (PTFE), which has become the source of the issue. The PTFE coatings may be faulty, causing them to potentially separate or detach from the Guidewire itself. These separations can lead to blood clots and obstructions, which can, in turn, lead to strokes and heart attacks. In fact, one patient has already suffered from cardiac arrest, but was resuscitated.
Medical devices are supposed to enhance our lives and health, but when they malfunction or perform in unintended ways, a situation can be made worse for a patient. Victims will not only have to deal with the immediate health ramifications (which can be as severe as death), but with the cost of another procedure, a longer hospital stay, and lost wages from missed work.
If you have had a defective medical device placed inside of your body, you have a right to seek legal recourse and you may be entitled to compensation. Contact the personal injury attorneys at Team Law today. Call 732-388-5454 for a free consultation.