Class 1 Recall of Medtronic Guidewires

November 18, 2013 — Medtronic Inc. and the U.S. Food and Drug Administration (FDA) have announced a Class 1 recall of the guidewires used during pacemaker implantation. The problem is that the coating on the guidewires can delaminate and detach.

According to product information for the Cougar guidewire, the coating is a water-repellent material called Hydro-Track.

Lots have been recalled from the following product lines:

• 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

Medtronic began notifying hospitals about problems with the guidewires on October 21. They warned that some lots manufactured after mid-April 2013 could be defective. The company has received one report of a patient who was injured.

In addition, according to this MAUDE adverse event, there was an incident in which the tip of the Zinger guidewire detached inside a patient. Doctors were unable to safely remove the tip, and so they left it inside the patient.

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