FDA Recalls Medtronic Heart Device

The Food and Drug Administration has issued a Class I recall of about 15,000 guidewires on various Medtronic heart devices, saying the defective coating on the wires could cause serious injury or death.

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Guidewires help guide other devices into place in the heart. A coating helps them slide through blood vessels more easily, but if this coating breaks off, it has the potential to obstruct bloodflow.

The recall began Oct. 21.

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