The U.S. Food & Drug Administration has issued a recall of Medtronic guidewires, which are inserted in arteries to guide stents and other devices into place during heart procedures. According to a report in USA Today, approximately 15,000 guidewires are in question and include those manufactured since April 2013.
Medtronic received at least four reports that the device’s coating – intended to make them slide through blood vessels more easily – could break off, potentially causing a blockage that might lead to serious injury or death.
Due to the potential harm posed by the defect, the FDA has designated this a Class I recall, defined 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.”
If you or someone you know had a Medtronic guidewire inserted during a heart procedure, please contact the attorneys at Sommers Schwartz to discuss your situation and the actions you may need to take to pursue a personal injury or mass tort claim.