Last month, Medtronic began a recall of its Interventional Wires and ATTAIN HYBRID guidewires due to the potential for serious injury. While Medtronic initially commenced a “voluntary field action,” the U.S. Food and Drug Administration (“FDA”) has since classified the recall as a Class I recall, which means that “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Class I is the most serious class of recall. According to the FDA, 14,896 guidewires from 181 different lots have been recalled.
Medtronic guidewires are used in a number of cardiac procedures, including percutaneous coronary interventions and defibrillator and pacemaker placements. The guidewire is inserted into a patient’s artery in order to guide the catheter in these procedures.
As of the date of recall, Medtronic has received a total of four complaints and one confirmed injury related to the defective wires. Reportedly, the exterior coating of the guidewires can delaminate and detach. This can cause blood clots in the patient’s artery, which can lead to heart attack and stroke.
This is not the first time Medtronic has had issues with its products. Six years ago, the company was forced to recall its Spring Fidelis defibrillation leads because the wires were reportedly prone to fractures, which had the potential to cause serious injury or death.
The eight Medtronic product lines that have been included in the October recall are: Cougar Nitinol Workhorse Guidewire, Cougar Steerable Guidewire, Zinger Stainless Steel Workhorse Guidewire, Zinger Steerable Guidewire, Thunder Extra-Support Guidewire, Thunder Steerable Guidewire, ProVia Crossing Guidewire and Attain Hybrid Guidewire.
Additional information about the recalled Medtronic guidewires can be found on the Medtronic website. If you have had one of these wires implanted, contact a physician immediately.
If you believe that you or a loved one has been harmed by a defective Medtronic guidewire, we encourage you to contact The Higgins Firm today. Our experienced drug recall attorneys would be happy to answer any questions you may have related to your potential claim.