FDA Recalls Maquet Heart Device Over Death, Injury Reports

By Jessica Corso (May 7, 2015, 4:42 PM EDT) -- The U.S. Food and Drug Administration sounded the alarm Thursday on a Maquet Medical Systems USA medical device used during heart surgery, following reports that 51 injuries and at least one death have been caused by the device tearing tissue in the top left chamber of the heart.

The FDA issued a Class 1 recall — the most serious of its kind — for Maquet's TigerPaw System II in March after receiving word from the company that there were complaints about the device causing bloody tears in the heart. In issuing the safety alert Thursday, the FDA noted that 51 injuries...

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