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- Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing DevicesVolara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.fda medwatch · 18d ago↗ source
- Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VIIndustry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry…raps · 18d ago↗ source
- Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.