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Fire Concerns Prompt Recall of Edwards Lifesciences’ Hospital Bedside Monitoring Systems

By Burg Simpson

Medical Chart

May 29, 2019   Ohio Dangerous Drugs and Medical Devices, Ohio Legal Updates

By John Roberts, Burg Simpson Associate

Fire Concerns Prompt Recall of Edwards Lifesciences’ Hospital Bedside Monitoring Systems

 On March 21, 2019, Edwards Lifesciences LLC initiated a recall of its EV1000 clinical platforms. “Clinical platforms” are best characterized as the bedside computer system used to monitor a patient’s pulse and blood pressure both during and after surgery. The recall was motivated by fire hazard concerns, as fluids leaking into the platforms’ electrical components can lead to electrical short circuits. In the case of a short circuit, the clinical platforms may stop working or catch fire.

On May 24, 2019, the Food and Drug Administration (“FDA”) issued a FDA recall notice identifying the following serious injury risks to patients and health care professionals alike: electrical shock, burns, and cardiac arrest, or even death. The FDA classified the Edwards Lifesciences’ recall as a Class I recall, the most serious type issued by the FDA. Class I designation is reserved for situations in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

The recall affects a total of 11,000 Edwards Lifesciences’ devices in the United States distributed between November 5, 2010 and March 4, 2019. The affected devices are all lots of Model Nos. EV1000A, EV1000NI, and EV1000CS.

If you or a loved one have suffered surgical complications or injuries related to an electrical short circuit of an Edwards Lifesciences’ bedside monitoring device, contact one of the experienced product liability attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

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