Complications with Left Atrial Appendage Occlusion (LAAO) Devices More Likely Among Women Than Men, FDA Warns
The FDA is warning that a form of heart surgery used to treat atrial fibrillation appears to carry greater health risks for women than men.
Tag Archives: Medical Device
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Medical Device Deaths Likely Undercounted By FDA, Study Warns
Medical device manufacturers often fail to report patient deaths as deaths, distorting the FDA's view on the safety profile of those devices, which could continue to put patients at risk,…
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FDA Safety Inspections Falling Further Behind Due To COVID-19 Pandemic, GAO Report Warns
While federal regulatory agencies continue to limit travel during the COVID-19 pandemic, a new government watchdog report warns that the U.S. Food and Drug Administration (FDA) has fallen even further…
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Pulse Oximeters Less Accurate When Used On Dark-Skinned People of Color, FDA Warns
The FDA warns that pulse oximeters may be more inaccurate when used on people of darker skin.
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Patients With AFX Endovascular Grafts Should Get Annual Checkups For Endoleaks: FDA
The FDA warns patients who received Endologix AFX Endovascular graft systems follow up with their doctor annually due to the risk of endoleaks which could cause health complications.
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Medical Device Safety Warnings To Be Subject of FDA Virtual Public Meeting
The FDA plans to hold a virtual meeting in November to discuss with the public ways to improve its medical device safety warnings.
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Water Circulating Hot/Cold Therapy Problems Result in FDA Warning Over Injury Risk
The FDA warns of potential injuries from hot and cold therapy devices if instructions are not closely followed.
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FDA Tells Doctors To Conduct Trial Stimulation Test Before Using Spinal Cord Stimulators
The FDA is advising doctors to have patients go through a trial period before permanently implanting a spinal cord stimulator for pain management.
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Generic EpiPens May Malfunction, Deliver Double Dose, FDA Warns
The FDA warns that some generic EpiPens may deliver an overdose of epinephrine due to a missing component.
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Abbott Warns of New Problems With HeartMate 3 Systems
Abbott is warning of power loss problems with its HeartMate 3 implants, which could lead to serious injuries or even death.