A guidewire is a device that a cardiac surgeon uses to support an artery so a catheter or pacemaker can be inserted over the wire and slid into place in a precise location in a patient’s body. Guidewire manufacturers coat the wires with a surface material that makes it easier for the device to slide smoothly to its destination.
Guidewires made by medical instrument manufacturer Medtronic have been recalled by the U.S. Food and Drug Administration. The coating on the recalled wires can break off inside the patient’s body, blocking a blood vessel and causing serious complications — even death.
The FDA classifies product recalls in three classes. The least serious ones are Class III recalls, where exposure to a product is unlikely to cause serious health consequences in a patient. Products categorized as Class II recalls may cause temporary health consequences in the short term, but serious, long-term complications are remote. Class I recalls are the most serious. They involve situations where exposure to the product will probably cause serious health consequences or death. The Medtronics Guidewire recall is a Class I product recall.
Consumers who have had Medtronics Guidewires inserted in their blood vessels must undergo surgery to remove the wires and repair any blockages or other damage caused by them. At Torklaw, we believe patients are entitled to be compensated when they have been injured by a large, publicly traded company such as Medtronics. Call us today to schedule a free meeting to discuss your Medtronics Guidewire recall case.