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.
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.
More Articles on the FDA:
HR Vendor Coalition Applauds FDA's New Regulatory Guidelines
HIMSS Weighs in on FDA Regulation for Health IT
FDA Issues Proposed Rule for Drug Shortage Early Notices