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FDA Issues Public Health Advisory for Trasylol
The Food and Drug Administration today issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasyolol (aprotinin injection), a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.
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FDA Approves Feasibility Trials of Arrow LionHeart Left Ventricular Assist Device
The US Food and Drug Administration has approved the first US trials of the Arrow LionHeart left ventricular assist device (LVAD). “We […]
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Medical Device Safety and Recalls: Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO)
FDA is alerting health care providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.
2 min read