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FDA Recalls Medtronic Guidewires


Defective Coating on Wires Can Complicate Cardiac Surgery

The Food and Drug Administration (FDA) has issued a Class I recall of 15,000 potentially lethal guidewires used in heart procedures. The defects in the guidewires, made by the Medtronic Company, could cause serious injury or death.

During cardiac surgery, the wires are inserted through an artery and used to guide other medical devices into place, such as heart stents. The wires have a coating which allows them to easily slide through blood vessels. The life-threatening danger lies in the defective coating around the guidewires, which could break off. This may increase the chances of blocking a blood vessel.

The recall, involving certain lots made since April, began after Medtronic received four complaints. One patient with a defective guidewire went into cardiac arrest but was resuscitated.

Medtronic claims to have taken steps to prevent new shipments of the wires and has notified regulators worldwide.

Source: “FDA issues stern warning on Medtronic devices.” November 16, 2013.