Feds ask Edwards Lifesciences for heart monitor recall documents

Edwards Lifesciences Corp. (NYSE:EW) revealed yesterday a U.S. Attorney’s Office for Central California subpoena for documents related to its 2006 heart monitor recall.

The Irvine, California-based cardiac device maker said the court communication came “in connection with an investigation by the federal Food & Drug Administration,” and sought “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.”

Edwards reported the news in its 10-Q quarterly earnings filing with the Securities & Exchange Commission and said it is “cooperating fully with the investigation.”

The company posted net earnings of $48.0 million, or 40 cents per diluted share, on sales of $348.9 million during the three months ended Sept. 30. That compares with net earnings of $73.5 million, or 63 cents per diluted share, on sales of $325.7 million during the same period last year.