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10 Series Plus Bluetooth Smart Blood Pressure Monitor BP786NRecalls & reported problems

Omron Healthcare, Inc. · Class 2

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

Adverse event reports
3
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00073796267865), received between Aug 31, 2018 and Mar 10, 2022 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Fire” (2 reports).

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

  • Fire2
  • Overheating of Device2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Death1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 10, 2022Fire; Overheating of Device; Fire; Overheating of Device

    THE CONSUMER REPORTED THAT HIS AC ADAPTER CAUGHT FIRE WHILE IT WAS PLUGGED INTO THE WALL. HE PULLED THE PLUG AND DOUSED THE FIRE OUT THEN THREW AWAY THE ADAPTER. HE HAD THE PART NUMBER FOR THE ADAPTER. IT WAS REQUESTED THAT HE SEND ANY PHOTOS OR SCREENSHOTS OF THE DAMAGE. NO PHOTOS HAVE BEEN SENT. HE REPAIRED THE OUTLET AT MINIMAL COST. DURING A FOLLOW-UP CALL, THE CONSUMER STATED THE AC ADAPTER MELTED THE OUTLET DUE TO OVERHEATING. THERE WAS NOT A FIRE IN THE OUTLET OR RADIATING UP THE WALL. THE ISSUE OCCURRED ABOUT 3 WEEKS AGO. THE UNIT WOULD WORK PROPERLY WHILE OPERATING WITH BATTERIES. HE WAS USING THE AC ADAPTER THAT CAME WITH THE UNIT, HEM-ADPTW5. HE NO LONGER HAD THE ADAPTER TO VERIFY THE MODEL NUMBER. HE ASSESSED THE OUTLET BY TAKING IT APART AND VERIFYING THAT THE AC ADAPTER CAUSED THE DAMAGE. HE HAD BEEN USING THE UNIT FOR 2 YEARS BUT NOT CONSISTENTLY. HE DID NOT LEAVE THE ADAPTER PLUGGED INTO THE OUTLET AND ONLY USED THE UNIT EVERY ONCE IN A WHILE. ONLY THE UNIT WAS PLUGGED INTO THE OUTLET. THE OUTLET WAS INSIDE WITH NO MOISTURE. THE UNIT WAS PLUGGED DIRECTLY INTO THE OUTLET. IT WAS REQUESTED THAT THE CONSUMER SEND IN THE UNIT AND A REPLACEMENT BP7450 WOULD BE SENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13717833 ↗
  • MalfunctionMar 4, 2022Fire; Overheating of Device; Fire; Overheating of Device

    THE CONSUMER REPORTED THAT HIS AC ADAPTER CAUGHT FIRE WHILE IT WAS PLUGGED INTO THE WALL. HE PULLED THE PLUG AND DOUSED THE FIRE OUT, THEN THREW AWAY THE ADAPTER. HE HAD THE PART NUMBER FOR THE ADAPTER. IT WAS REQUESTED THAT HE SEND ANY PHOTOS OR SCREENSHOTS OF THE DAMAGE. NO PHOTOS HAVE BEEN SENT. HE REPAIRED THE OUTLET AT MINIMAL COST. DURING A FOLLOW-UP CALL, THE CONSUMER STATED THE AC ADAPTER MELTED THE OUTLET DUE TO OVERHEATING. THERE WAS NOT A FIRE IN THE OUTLET OR RADIATING UP THE WALL. THE ISSUE OCCURRED ABOUT 3 WEEKS AGO. THE UNIT WOULD WORK PROPERLY WHILE OPERATING WITH BATTERIES. HE WAS USING THE AC ADAPTER THAT CAME WITH THE UNIT, HEM-ADPTW5. HE NO LONGER HAD THE ADAPTER TO VERIFY THE MODEL NUMBER. HE ASSESSED THE OUTLET BY TAKING IT APART AND VERIFYING THAT THE AC ADAPTER CAUSED THE DAMAGE. HE HAD BEEN USING THE UNIT FOR 2 YEARS BUT NOT CONSISTENTLY. HE DID NOT LEAVE THE ADAPTER PLUGGED INTO THE OUTLET AND ONLY USED THE UNIT EVERY ONCE IN A WHILE. ONLY THE UNIT WAS PLUGGED INTO THE OUTLET. THE OUTLET WAS INSIDE WITH NO MOISTURE. THE UNIT WAS PLUGGED DIRECTLY INTO THE OUTLET. IT WAS REQUESTED THAT THE CONSUMER SEND IN THE UNIT AND A REPLACEMENT BP7450 WOULD BE SENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13672708 ↗
  • DeathAug 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CONSUMER REPORTED THAT UNIT WAS NOT PROVIDING A READING. CONSUMER STATED THE UNIT IS INFLATING AND DEFLATING BUT NOT PROVIDING A READING. THE UNIT WOULD NOT PROVIDE A READING FOR HER HUSBAND AND HAD SHE KNOWN HIS BLOOD PRESSURE WAS AS HIGH AS IT WAS HER HUSBAND MAY NOT HAVE DIED FROM A LEAKING ANEURYSM. CONSUMER STATED THAT THE UNIT STILL WOULD NOT WORK ON HERSELF. CALLER STATES SHE WOULD REALLY LIKE A REFUND. CUSTOMER SERVICE REPRESENTATIVE ADVISED CONSUMER THAT THE TRUREAD MODE IS ON AND ASSISTED TURNING THE FEATURE OFF. CONSUMER WAS ADVISED CALLER TO TAKE A BP READING AND CALLER RECEIVED A READING. QUALITY MANAGER (QM) CALLED CONSUMER AND APOLOGIZED FOR CONSUMER'S LOSS OF HER HUSBAND AND OFFERED A REFUND AND REPLACEMENT UNIT. CONSUMER STATED SINCE THE UNIT IS WORKING, LET'S JUST FORGET ABOUT IT. CONSUMER STATED THE CUSTOMER SERVICE AGENT HELPED HER THIS MORNING AND SHE WAS ABLE TO GET HER BLOOD PRESSURE (BP) MEASUREMENT. SHE HAD SMALL PROCEDURE DONE COUPLE OF DAYS AGO AND WAS TRYING TO TAKE HER BP MEASUREMENT RECENTLY AND WAS NOT ABLE. BUT NOW THE UNIT IS WORKING. CONSUMER CONFIRMED HER HUSBAND PASSED AWAY ABOUT 3 MONTHS AGO. CONSUMER STATED HER HUSBAND HAD TONS OF PROBLEMS PRIO

    Patient problems: Death

    MAUDE report 7838779 ↗

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

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Sources and updates

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