The FDA is warning consumers and healthcare providers not to rely on unauthorized blood pressure devices.
Many of the devices sold over the counter lack FDA authorization, according to a Sept. 16 news release from the agency. Using such a device, the safety and accuracy of which have not been verified, could result in misdiagnosis or delay treatment of high or low blood pressure, which could potentially cause stroke, heart attack, kidney failure or death.
The agency advised consumers to avoid unauthorized products, check the FDA’s 510K database to confirm whether a device has been authorized and consult a healthcare provider to pick the appropriate device, the release said.
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