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Evolv Upper Arm Blood Pressure Monitor BP7000Recalls & reported problems

Omron Healthcare, Inc. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00073796270001), received between Oct 9, 2018 and Oct 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Overheating of Device1
  • Smoking1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 9, 2018Overheating of Device; Smoking; Overheating of Device; Smoking

    CONSUMER REPORTED HE RECENTLY RECEIVED THE EVOLV WIRELESS BLOOD PRESSURE MONITOR AS A BIRTHDAY GIFT. HE PUT THE BATTERIES IN THE UNIT AND WENT TO USE THE BATHROOM; WHEN HE CAME BACK THERE WAS A HOT LIQUID COMING OUT OF THE UNIT AND IT STARTED SMOKING. EVENTUALLY, THE UNIT WAS ON FIRE AND IT BASICALLY BURNT UP THE WHOLE DEVICE. THE CONSUMER WROTE THAT HE WAS DISAPPOINTED AND UPSET ABOUT IT, ESPECIALLY BECAUSE IT WAS A GIFT. IT JEOPARDIZED THE SAFETY OF HIS FAMILY. HIS WIFE IS PREGNANT AND HE HAS CHILDREN. ONE OF HIS CHILDREN HAS ASTHMA AND IT IS RIDICULOUS AND UNACCEPTABLE THAT THIS EVEN HAPPENED IN THE FIRST PLACE. HE IS STILL AT A LOSS OF WORDS OVER THIS WHOLE INCIDENT AND IT WAS COMPLETELY UNACCEPTABLE. HE HAD TO DISPOSE OF THE UNIT DUE TO THE SMOKE AROMA WHICH WAS IN THE DEVICE AND HIS HOUSE. THE QUALITY ANALYST EMAILED THE CONSUMER REQUESTING A CALL BACK TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT. THE CONSUMER SENT AN EMAIL TO THE QUALITY ANALYST. IN THE EMAIL, THE CONSUMER WROTE THAT HE DOES NOT THINK HE CAN GET A REFUND SINCE HE RECEIVED THE UNIT AS A GIFT. HE HAD JUST RECEIVED THE UNIT AND HAD NOT EVEN USED IT FOR ONE DAY. HE WAS ONLY USER AND RECEIVED THE UNIT BR

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7949205 ↗

Other System, Measurement, Blood-Pressure, Non-Invasive devices

All System, Measurement, Blood-Pressure, Non-Invasive devices →

Sources and updates

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