July 1, 2019 / 8:12 PM / 3 months ago

FDA says three deaths related to Edwards Lifesciences' recalled heart devices

July 1 (Reuters) - The U.S. Food and Drug Administration said on Monday three deaths had been reported related to Edwards Lifesciences Corp’s recall of some of its heart devices.

The agency said the company’s voluntary recall of its IntraClude Intra-Aortic Occlusion device in May has now been classified by the FDA as a Class I, the most serious type of recall.

The recall was due to a risk of balloon rupture during use of the device, the FDA said here adding the company received 22 complaints related to the device. (Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Shailesh Kuber)

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