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.
Robert B. Sickels
For more than 30 years, Robert Sickels has successfully represented plaintiffs involved in complex personal injury, medical negligence, and products liability matters.
