The US Food and Drug Administration (FDA) has classified Medtronic's recently initiated voluntary field action related to certain guidewires as a class I recall.
The company initiated recalling some models of its guidewires from recent lots in the week of Oct. 21, after receiving four complaints, including one patient injury, of the coating on the surface of the guidewires detaching.
Medtronic has also taken the necessary steps to prevent new shipments of the recalled products and notified regulatory agencies around the world as appropriate.
The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices.
The FDA defines a class I recall as a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.