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Edwards Lifesciences recalls blood pressure, pulse analyzers


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Edwards Lifesciences recalls blood pressure, pulse analyzers

Edwards Lifesciences Corp. unit Edwards Lifesciences LLC has recalled several analyzers used during and after surgery to measure a patient's blood pressure and pulse.

The recall is based on the risk of fluid leakage into the power outlets of these analyzers, which can cause device failure or lead to a fire.

The U.S. Food and Drug Administration has classified the recall as the most serious type, as it can cause serious injury to patients and health care professionals, including electrical shock, burns, cardiac arrest or death. The regulator noted that odds of fire are higher in oxygen-rich environments, like operating rooms and intensive care units.

Edwards Lifesciences on March 21 initiated the recall of 11,000 EV1000A, EV1000NI and EV1000CS clinical platforms distributed between Nov. 5, 2010, and March 4, 2019.

The company has asked customers to keep fluids away from the power connector to avoid contact with electrical components.