The U.S. Food and Drug Administration believes there is a reasonable probability that use of lots of Medtronic Inc's medical guidewires that were recalled in October could be fatal, the medical device maker said on Friday.
Medtronic spokesperson Joseph McGrath said the company started recalling 14,896 guidewires, or 181 lots, in the week of October 21, after receiving four complaints, including one patient injury, of the coating on the surface of the guidewires detaching.
A guidewire is inserted into an artery to guide a catheter to a particular location in the body. The guidewires covered by the recall are designed to facilitate percutaneous coronary interventions, or the placement of left ventricular leads for cardiac rhythm devices, Medtronic said in a statement.
Medtronic said the FDA classified the recall as a Class I, meaning that the regulator believes there is a reasonable probability that use of, or exposure to, the guidewires will cause serious adverse health consequences, or death.
McGrath said the company does not expect the recall to have a material impact on its financial results. He said it had taken the necessary steps to prevent future shipments of the recalled products and had notified regulatory agencies around the world of the recall.