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
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- Medline MDS4003Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive398 reports
- Medline MDS4001Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive267 reports
- Medline MDS3001UMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive170 reports
- Medline MDS1001CSMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive1 recall57 reports
- Ultraview SL Ultraview SL®Spacelabs Healthcare (Washington), Inc · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE2 recalls2 reports
- DTX(TM) PLUS DT-4812 682000Argon Critical Care Systems Singapore Pte. Ltd. · System, Measurement, Blood-Pressure, Non-Invasive86 reports
- Medline MDS7001BMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive81 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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