Medtronic ($MDT) began a month ago to recall a number of potentially faulty guidewires used for various cardiac procedures, and now the FDA has slapped the effort with its most-serious "Class I" label. At least one patient has been injured, the company said.
The Minnesota device giant disclosed that it initiated a "voluntary field action" in late October involving various Cougar, Zinger, Thunder, ProVia and Attain Hybrid guidewires, following reports that the coating on the surface of some models could delaminate and detach. The guidewires are used for procedures such as percutaneous coronary interventions, and also to place left ventricular leads for cardiac rhythm devices such as defibrillators and pacemakers, according to Medtronic.
One patient has been reported injured, and a Medtronic spokesperson told Reuters that there have been four complaints to date. As a result, 181 lots involving 14,896 guidewires have been recalled, according to the article.
A Class I recall acknowledges that the problem involved could cause serious injury or death. With that in mind, Medtronic said it has responded quickly. The company noted in its recall announcement that it began notifying regulators, hospitals and distributors around the world about the problem in October, and immediately asked that all affected units be set aside and returned for credit/replacement.
Additionally, Medtronic said it has acted to stop future shipments of the recalled products.
Despite the recall, Medtronic has advanced on a number of other fronts. The company was victorious in a recent German appeals court ruling that lifted an injunction preventing the sale of its CoreValve transcathether aortic heart valve in the country. The action was a major defeat for archrival Edwards Lifesciences ($EW), which has argued that CoreValve violates patents involving its market-leading Sapien valve.
Medtronic is scheduled to report its fiscal 2014 second-quarter earnings on Nov. 19.
- read the release
- here's Reuters' take