Minneapolis, MN: Medtronic, Inc. (NYSE: MDT) announced today that the US Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to certain guidewires as a Class I recall.
The FDA action is based on an internal investigation following a limited number of complaints and patient injury. Medtronic began notifying hospitals and distributors worldwide the week of October 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. The notification requested that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement.
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.
The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. They include specific lots from the following eight product lines that were manufactured after mid-April 2013:
Cougar nitinol workhorse guidewire
Cougar steerable guidewire
Zinger stainless steel workhorse guidewire
Zinger steerable guidewire
Thunder extra-support guidewire
Thunder steerable guidewire
ProVia crossing guidewire
Attain Hybrid guide wire
