Latest Safety & Recalls stories in Health, with AI-generated summaries from NewsSnap.ai.
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Follow Safety & RecallsThe FDA has issued an early alert regarding certain delivery systems for Edwards Lifesciences' Sapien M3 transcatheter mitral valve replacement system. This warning follows reports of balloons bursting during inflation, which has been linked to one patient death and one serious injury. The agency advises against using the affected delivery systems for patient care to ensure safety.
The U.S. FDA has issued a high-risk alert for a recall of specific Edwards Lifesciences Commander M delivery systems. This action follows reports of balloons bursting during mitral heart valve implantation procedures, leading to one patient death and a serious injury. Facilities are instructed to cease use and remove affected devices from inventory to prevent further harm.
The UK's MHRA is enhancing safety warnings for antidepressants, updating patient information leaflets with a new boxed warning about suicidal thoughts and behaviors. A new patient card will also reinforce key safety messages. Additionally, the term 'post-SSRI sexual dysfunction' (PSSD) will be explicitly added to highlight the risk of persistent sexual difficulties after treatment cessation, aiming to improve patient awareness.