The U.S Food and Drug Administration has issued an early alert for Boston Scientific defribrillation wires. According to Associated Press reporting, "the company’s Endotak Reliance defibrillator wires can become calcified, leading to failures in delivering life-saving shocks to the heart."

This early alert is for the ENDOTAK RELIANCE, RELIANCE 4-FRONT and RELIANCE 4-SITE. The FDA recommend physicians continue routine follow-up of defibrillation systems with ePTFE leads either via in-person or remote monitoring (RM) per labeling or medical guidelines with consideration that RM can facilitate early detection of this pattern.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Read the Full Alert on the FDA site.