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In a healthcare landscape increasingly shaped by technology, two names that stand out for their innovation and long-term ...
Coating for the guidewires could come off and get left in patients, which could result in extended or additional procedures.
Bengaluru: The U.S. Food and Drug Administration on Tuesday classified the recall ... the device failing to properly attach or stay attached to the blood vessel wall during and after procedures ...
The recall followed reports of the device's tube section failing to properly adhere to the blood vessel during and after the medical procedures, the FDA noted, adding that the risk was higher in ...
On Jan. 30, 2025, Medtronic sent an urgent medical device recall letter recommending that customers do not use and return all unused 027 devices. They should read the updated instructions before ...
Recalls, whether involving medical devices, pharmaceuticals ... A comprehensive recall policy is important for standardizing response procedures and ensuring compliance with regulatory guidelines, ...
Lee, a practicing lawyer, provided some reassuring data about the legalities of using medical devices under recall ... "no," then he will back off on the procedure, he said.
“Machines break, wires break, and so the chance that a medical device will fail is real. It’s a small chance, but it’s real and should be discussed.” When Kovacs hears about a device ...
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