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- FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reportsThe FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter m…
- BD and CareFusion recall Alaris Pump infusion sets due to serious performance risksThe FDA has classified the recall of BD Alaris Pump infusion sets as the most serious type, warning that continued use could cause serious injury or death. BD and its subsidiary CareFusion sent an…fda medwatch · 5d agoCRLNegative