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The single-arm study will span at least 50 sites in Europe, Asia and South America, and will involve patient follow-up at 30 days, six months, then every year for five years. Read More
Healthcare providers that used the test and suspect a recent inaccurate result should consider retesting patients with a different COVID-19 test, the agency said. Read More
The reported failures included ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the catheter’s distal-tip region. Read More
While there have been no reported deaths, there have been 57 complaints and 14 reports of serious injuries stemming from the issue, the FDA said. Read More
“The Jet 7 Xtra Flex catheter “is not able to withstand the same burst pressures” to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus in acute ischemic stroke patients,” the agency said. Read More
“Successful exploitation of these vulnerabilities together could result in the attacker being able to modify or fabricate data from the implanted cardiac device being uploaded to the CareLink Network and remotely execute code … which could allow control of a paired cardiac device,” DHS warned. Read More
“Nontuberculous mycobacteria (NTM) patient infections, NTM device contamination and, in some cases, both issues have now been reported for all manufacturers of heater-cooler devices in the U.S.,” the FDA noted. Read More
Use of the defective devices could lead to patient injury or death, the agency warned, noting that 1,186 issues and a single injury have been reported so far. Read More
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