Medtronic Announces Class I Recall of Guidewires

November 15, 2013—Medtronic, Inc. (Minneapolis, MN) announced that the company's recently initiated voluntary field action related to certain guidewires has been classified as a class I recall by the US Food and Drug Administration (FDA).

According to the company, an internal investigation was conducted after there were a limited number of complaints, including one patient injury. During the week of October 21, Medtronic began notifying hospitals and distributors worldwide that some models of its guidewires from recent lots have the potential for the surface coating 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. Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate.

Medtronic advised that 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.

Medtronic stated that the recalled devices 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, and Attain Hybrid guidewire.

Additional information about the recall, including the lot numbers of affected product, is accessible through the Medtronic website. Observations and consequences of the coating issue related to these guidewires should be reported to Medtronic in the United States by calling (877) 526-7890 on weekdays from 8 AM to 5 PM. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm or by phone at (800) FDA-1088.