Regulators have determined that defects in some medical devices made by Medtronic Inc.have the potential to cause serious harm or death, according to statements issued by the company and the U.S. Food and Drug Administration Friday night.
The FDA's determination relates to a recall initiated by Medtronic last month of nearly 15,000 guidewires manufactured since April that are used in heart procedures. The FDA has now designated the action as a Class I recall, the most serious classification given to product recalls.
