FDA Roundup: December 15, 2023
/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated the...
Source: prnewswire.com
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Top News In Device Reports Today - Breaking & Trending Today
Malfunctioning Integra intracranial monitor was used on patient who died: FDA
MedTech industry news
Source: medtechdive.com
FDA: Class I Recall for Seven Models of Medtronic ICDs and CRT-Ds
April 12, 2021 The US Food and Drug Administration is warning physicians about a recall initiated in February for several implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured by Medtronic: Evera, Viva, Brava, Claria, Amplia, Compia, and Visia. Today, the FDA categorized this action as a Class I recall, its most serious type, meaning that use could cause serious injuries or death. The devices are being recalled due to an unexpected and rapid decrease in battery life caused by a short circuit. This defect may case some devices...
Source: tctmd.com