The FDA, prompted by multiple reports that the Edwards Lifesciences (NYSE:EW) IntraClude balloon burst that included three deaths, yesterday gave the device’s recall Class I status.

The IntraClude device is designed to occlude the aorta during cardiopulmonary bypass procedures.

Last month, Irvine, Calif.-based Edwards put out a field safety notice about the high-risk balloon bursts, which can cause the heart to fill and warm and obscure the operative site.

At the time Edwards reported an increase in complaints between January and April. Yesterday the FDA said that Edwards reported receiving 22 complaints related to balloon rupture or puncture, including the three fatalities. The recall covers 757 IntraClude devices, according to the federal safety watchdog.