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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The FDA warns that some generic EpiPens may deliver an overdose of epinephrine due to a missing component.…
Abbott is warning of power loss problems with its HeartMate 3 implants, which could lead to serious injuries or even death.…
The FDA has expanded warnings about leaks linked to endovascular grafts to multiple devices used to treat abdominal aortic aneurysms.…
The FDA warns that some old software used in medical devices may leave them exposed to hackers who could change their settings and potentially cause injury to patients.…
The FDA has a proposed a new draft guidance to improve safety on some critical medical devices.
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A Colorado hospital faces a lawsuit from numerous former patients who say failure to sterilize its medical devices led to infections and at least one death.…
The FDA warns of a shortage of pediatric breathing tubes following the shutdown of a key manufacturing facility.…
The FDA is warning consumers not to use tests which claim to be able to diagnose concussions or other head trauma without the supervision of a doctor.…
The FDA warns that the Abiomed Impella RP System has a higher rate of mortality among patients than its initial clinical trials predicted, potentially because the manufacturer did not take into account many real-world factors affecting patients.…
The FDA is warning doctors to be wary of the risks of air embolisms linked to the use of drug infusion pumps and similar devices.…