The U.S. Food and Drug Administration (FDA), is warning consumers of a Class I recall on “some Medtronic devices used during heart procedures.” The recall is estimated to affect some 15,000 devices.
The recalled devices are guidewires – long thing wires – that are inserted through an artery and used to guide other devices, such as stents, into place. The devices have a coating – polytetrafluoroethylene or PTFE – which helps the wires to slide – can detach and potentially block the blood vessel.
The recall was initiated in October after Medtronic was notified of four problems which included one patient suffering cardiac arrest. All new shipments of the devices have been stalled while the company works with the agency to fix this issue.
Consumers are urged to visit the FDA Website for more information or they can call Medtronic directly at 1-877-526-7890. If you have experienced any issues you think are may be associated with this device you should see your medical doctor and also report the incident to the FDA as it helps them to have a better understanding of the devices and more accurate recalls.