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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…
- Abiomed issues recall of Automated Impella Controllers over purge cassette detection issueAbiomed has announced a recall of its Automated Impella Controllers after identifying failures in the purge cassette recognition system, which could lead to prolonged delays in mechanical circulato…fda medwatch · 25d agoRegulatoryNegative