Edwards Lifesciences: Feds closed probe into recalled Vigilance I heart monitor

November 7, 2012 by MassDevice staff

Federal investigators closed a probe into Edwards Lifesciences' recalled Vigilance I monitor, according to a regulatory filing.

Edwards Lifesciences

Edwards Lifesciences (NYSE:EW) said a federal probe into its Vigilance I heart monitor, which it recalled in 2006, has been called off.

The U.S Attorney for Central California subpoenaed Irvine, Calif.-based Edwards in November 2010, seeking  "records relating to the Vigilance I Monitor model with software release 5.3 that was the subject of a voluntary field recall by the Company in June 2006."

The medical device company said at the time that it would cooperate with the probe. Now the feds have told the company that the investigation is over, according to a regulatory filing.

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"In October 2012, the company was advised by the U.S. Attorney's office that it is declining to pursue a criminal investigation and/or prosecution at this time," according to the filing.

Edwards pulled the Vigilance I monitor in August 2006, citing a software glitch that could cause the device to deliver power to a catheter without alerting users, potentially causing the catheter to overheat while inside the patient.