Omron Platinum Upper Arm Blood Pressure Monitor BP5450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00073796265458), received between Jan 24, 2023 and Jan 31, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “High Readings” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2023High Readings; High Readings

  THE CONSUMER HAD STATED THAT HER READING WERE HIGH AT 180/110, WHEN COMPARED TO HER DOCTORS READING WHICH HAD BEEN 150/80. BASED ON HER READINGS FROM HER UNIT HER DOCTOR HAD INCREASED HER MEDICATION. CALLER STATES HAD A SEVERE FALL AND WAS HOSPITALIZED DUE TO BEING OVER MEDICATED. DURING FOLLOW-UP CALL WITH OMRON REPRESENTATIVE, CONSUMER STATED THAT ON (B)(6) 2022 SHE HAD A TERRIBLE FALL, DUE TO BEING OVER MEDICATED. THE CONSUMER HAD EXPLAINED THAT DURING THE FALL, SHE HAD LOST TEETH, SHE HAD A CONCUSSION AND SHE HAD BEEN HOSPITALIZED. THE CONSUMER HAD STATED THAT SHE IS THE ONLY PERSON USING THE UNIT. SHE HAD ALSO STATED HER ARM IS 16 1/2 INCHES. THE CONSUMER HAD EXPLAINED THAT SHE HAD NEVER HAD PROBLEM WITH HER READINGS AT THE DOCTOR'S OFFICE; SHE HAD STATED THE READINGS HAD ALWAYS BEEN NORMAL. OMRON CUSTOMER SERVICE REPRESENTATIVE ADVISED CONSUMER STOP USING THE UNIT AND NOT ADJUST MEDICATION BASED ON THE MEASUREMENT RESULTS FROM THE HOME BLOOD PRESSURE MONITOR. CONSUMER WAS ADVISED THAT ONLY PHYSICIAN IS QUALIFIED TO DIAGNOSE AND TREAT HIGH BLOOD PRESSURE

  Patient problems: Concussion; Fall; Loss of consciousness; Tooth Loss

  MAUDE report 16274095 ↗
• InjuryJan 24, 2023High Readings; High Readings

  THE CONSUMER HAD STATED THAT HER READING WERE HIGH AT 180/110, WHEN COMPARED TO HER DOCTORS READING WHICH HAD BEEN 150/80. BASED ON HER READINGS FROM HER UNIT HER DOCTOR HAD INCREASED HER MEDICATION. CALLER STATES HAD A SEVERE FALL AND WAS HOSPITALIZED DUE TO BEING OVER MEDICATED. DURING FOLLOW-UP CALL WITH OMRON REPRESENTATIVE, CONSUMER STATED THAT ON (B)(6) 2022 SHE HAD A TERRIBLE FALL, DUE TO BEING OVER MEDICATED. THE CONSUMER HAD EXPLAINED THAT DURING THE FALL, SHE HAD LOST TEETH, SHE HAD A CONCUSSION AND SHE HAD BEEN HOSPITALIZED. THE CONSUMER HAD STATED THAT SHE IS THE ONLY PERSON USING THE UNIT. SHE HAD ALSO STATED HER ARM IS 16 ½ INCHES. THE CONSUMER HAD EXPLAINED THAT SHE HAD NEVER HAD PROBLEM WITH HER READINGS AT THE DOCTOR'S OFFICE; SHE HAD STATED THE READINGS HAD ALWAYS BEEN NORMAL. OMRON CUSTOMER SERVICE REPRESENTATIVE ADVISED CONSUMER STOP USING THE UNIT AND NOT ADJUST MEDICATION BASED ON THE MEASUREMENT RESULTS FROM THE HOME BLOOD PRESSURE MONITOR. CONSUMER WAS ADVISED THAT ONLY PHYSICIAN IS QUALIFIED TO DIAGNOSE AND TREAT HIGH BLOOD PRESSURE.

  Patient problems: Concussion; Fall; Loss of consciousness; Tooth Loss

  MAUDE report 16232872 ↗