FDA reports Edwards’ recall of EV1000 clinical platforms

Edwards Lifesciences is recalling EV1000A, EV1000NI, EV1000CS EV100 Clinical Platforms due to the potential for fluids to leak into the AC power outlet on both the EV1000A and the EV1000NI clinical platforms, the FDA reported. “Use of these products can result in electrical short circuit, which may cause the device to stop working or lead to a fire,” the FDA recall notice stated. The FDA has identified this as a Class I recall, the most serious type of recall. The recall was initiated on March 21 and Edwards previously sent “Urgent Medical Device Safety Notification” letters informing customers of affected model/lot numbers and advising customers to keep IV fluid bags and other fluids away from the AC power connector to avoid liquids leaking into the electrical components beginning on March 13, the FDA said.

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