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“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
One problem described in the recall, in which parts of the LED display appear dim, was classified as Class II, meaning use of the product may cause temporary or medically reversible adverse health events. Read More
One of the biggest downfalls of the MHRA during the pelvic mesh failure was not listening to patient concerns and responding too slowly, the report found. Read More