The US Food and Drug Administration has posted a series of safety alerts in the past week as part of the device center’s ongoing recalls communications pilot.
BD Catheter For Removing Arterial Plaque Linked To Deaths In FDA Early Alert
While communications from the FDA have been scant since the presidential transition, early alerts from the agency’s device center are flowing again. The most recent alert includes an issue with numerous injuries and four deaths associated with a device used during cardiac procedures.
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A failure to properly route cardiac events has led Philips to recall its heart monitoring software that interprets ECG data. Multiple injuries and two deaths are associated with the problem.