Omron 3 Series Upper Arm Blood Pressure Monitor BP7100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00073796710026), received between Mar 11, 2020 and Dec 4, 2020 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2020Inflation Problem; Physical Resistance/Sticking

  CONSUMER REPORTED THAT CUFF OVERINFLATED AND HURT HER ARM. THIS HAPPENED ABOUT 6 WEEKS AGO. THE CUFF SEEMED TO GET STUCK AND WOULD NOT RELEASE WHEN BUTTON WAS PUSHED. HER FINGERS WENT NUMB AND NOW SHE HAS NUMBNESS AND TINGLING ALL THE WAY DOWN THE ARM. SHE WENT TO THE DOCTOR AND IS ON PAIN MEDICATION. HER RIGHT ARM SIZE IS 9.5". CONSUMER DID NOT KNOW NOW HOW HIGH UNIT INFLATED BUT IT WAS OVER 220. CONSUMER DOES NOT PAY ATTENTION TO WHERE AIR HOSE LINES UP. HER NORMAL BLOOD PRESSURE READING RANGE IS 130/70. CONSUMER APPLIES CUFF ? INCH ABOVE ELBOW ON BARE SKIN, AIR HOSE IN LINE WITH MIDDLE FINGER AND SITS IN UPHOLSTERED CHAIR WITH ARM ON A TABLE. THE CUFF NOT APPLIED SNUG. CONSUMER WAS PROVIDED PROPER RIGHT ARM CUFF APPLICATION. CONSUMER WAS ADVISED NOT TO USE THE UNIT AGAIN AND SENT PREPAID SHIPPING LABEL TO RETRIEVE THE UNIT FOR FURTHER INVESTIGATION. DURING FOLLOW-UP CALL ON NOVEMBER 13, 2020. CONSUMER STATED UNIT OVER INFLATED THE ONE TIME. IT INFLATED SO HIGH THAT HER FINGERS WENT NUMB. THIS WAS AROUND (B)(6), SHE STILL FEELS THE PAIN, TINGLING AND NUMBNESS IN HER FINGERS. THE PAIN HAS SUBSIDED A LITTLE BIT BUT IS STILL THERE. IT WAS EXCRUCIATING, DID, AND STILL DOES INTERFERE

  Patient problems: Nerve Damage; Pain

  MAUDE report 10948200 ↗
• InjuryDec 1, 2020Therapeutic or Diagnostic Output Failure

  CONSUMER REPORTED THAT CUFF OVERINFLATED AND HURT HER ARM. THIS HAPPENED ABOUT 6 WEEKS AGO. THE CUFF SEEMED TO GET STUCK AND WOULD NOT RELEASE WHEN BUTTON WAS PUSHED. HER FINGERS WENT NUMB AND NOW SHE HAS NUMBNESS AND TINGLING ALL THE WAY DOWN THE ARM. SHE WENT TO THE DOCTOR AND IS ON PAIN MEDICATION. HER RIGHT ARM SIZE IS 9.5". CONSUMER DID NOT KNOW NOW HOW HIGH UNIT INFLATED BUT IT WAS OVER 220. CONSUMER DOES NOT PAY ATTENTION TO WHERE AIR HOSE LINES UP. HER NORMAL BLOOD PRESSURE READING RANGE IS 130/70. CONSUMER APPLIES CUFF ½ INCH ABOVE ELBOW ON BARE SKIN, AIR HOSE IN LINE WITH MIDDLE FINGER AND SITS IN UPHOLSTERED CHAIR WITH ARM ON A TABLE. THE CUFF NOT APPLIED SNUG. CONSUMER WAS PROVIDED PROPER RIGHT ARM CUFF APPLICATION. CONSUMER WAS ADVISED NOT TO USE THE UNIT AGAIN AND SENT PREPAID SHIPPING LABEL TO RETRIEVE THE UNIT FOR FURTHER INVESTIGATION. DURING FOLLOW-UP CALL ON NOVEMBER 13, 2020. CONSUMER STATED UNIT OVER INFLATED THE ONE TIME. IT INFLATED SO HIGH THAT HER FINGERS WENT NUMB. THIS WAS AROUND ON (B)(6). SHE STILL FEELS THE PAIN, TINGLING AND NUMBNESS IN HER FINGERS. THE PAIN HAS SUBSIDED A LITTLE BIT BUT IS STILL THERE. IT WAS EXCRUCIATING, DID, AND STILL DOES INTERFE

  Patient problems: Nerve Damage; Pain

  MAUDE report 10929476 ↗
• InjuryMar 12, 2020High Readings; High Readings

  CONSUMER REPORTED THAT THE UNIT WAS READING HIGH AND WAS GIVEN A MEDICATION BASED ON THOSE READINGS. AFTER THE MEDICATION CHANGE, SHE FAINTED TWICE, WAS INJURED, AND WAS IN THE HOSPITAL FOR 36 HOURS. SHE IS THE ONLY USER, USING IT THREE TIMES A DAY AND HAS HAD UNIT SINCE (B)(6) 2020. PER CONSUMER, THE UNIT HAS BEEN READING HIGH FROM THE FIRST USE. THE CUFF SIZE IS CORRECT AND THE CUFF WAS SECURED. THE AVERAGE BLOOD PRESSURE WHEN USING THIS MACHINE WAS IN THE ~ HIGH RANGE OF 130'S OVER HIGH 80'S. AT THE DOCTOR'S OFFICE, HER READING WAS 114/76. CONSUMER STATED AT THE DOCTOR'S OFFICE, OMRON UNIT INFLATED TO 150 TO 170 AND GAVE READING OF 140/90. AT THE HOSPITAL, HER READING WAS VERY LOW. AFTER A SODIUM DRIP, IT CAME UP TO MORE NORMAL READING. CONSUME STATED HER HOME UNIT READ HIGH SO SHE CALLED DOCTOR AND DOCTOR CHANGED HER MEDICATION TO DIURETIC. THE CUSTOMER FAINTED TWICE AND HER PRESSURE AT THAT TIME WAS 72/56. AT THE HOSPITAL, HER MEDICATION WAS CHANGED AT THE HOSPITAL. THE CUSTOMER WAS IN THE HOSPITAL FOR 36 HOURS. SHE HAD A BROKEN THUMB AND FACIAL LACERATIONS. BLOOD WORK AND ECHOCARDIOGRAM. X-RAYS OF HAND AND CHEST. CAT SCAN FOR BRAIN BLEED. DURING FOLLOW-UP CALL ON MARCH 9, CON

  Patient problems: Bone Fracture(s); Electrolyte Imbalance; Fainting; Laceration(s)

  MAUDE report 9827556 ↗
• InjuryMar 11, 2020High Readings; High Readings

  CONSUMER REPORTED THAT THE UNIT WAS READING HIGH AND WAS GIVEN A MEDICATION BASED ON THOSE READINGS. AFTER THE MEDICATION CHANGE, SHE FAINTED TWICE, WAS INJURED, AND WAS IN THE HOSPITAL FOR 36 HOURS. SHE IS THE ONLY USER, USING IT THREE TIMES A DAY AND HAS HAD UNIT SINCE (B)(6) 2020. PER CONSUMER, THE UNIT HAS BEEN READING HIGH FROM THE FIRST USE. THE CUFF SIZE IS CORRECT AND THE CUFF WAS SECURED. THE AVERAGE BLOOD PRESSURE WHEN USING THIS MACHINE WAS IN THE ~ HIGH RANGE OF 130'S OVER HIGH 80'S. AT THE DOCTOR'S OFFICE, HER READING WAS 114/76. CONSUMER STATED AT THE DOCTOR'S OFFICE, OMRON UNIT INFLATED TO 150 TO 170 AND GAVE READING OF 140/90. AT THE HOSPITAL, HER READING WAS VERY LOW. AFTER A SODIUM DRIP, IT CAME UP TO MORE NORMAL READING. CONSUME STATED HER HOME UNIT READ HIGH SO SHE CALLED DOCTOR AND DOCTOR CHANGED HER MEDICATION TO DIURETIC. THE CUSTOMER FAINTED TWICE AND HER PRESSURE AT THAT TIME WAS 72/56. AT THE HOSPITAL, HER MEDICATION WAS CHANGED AT THE HOSPITAL. THE CUSTOMER WAS IN THE HOSPITAL FOR 36 HOURS. SHE HAD A BROKEN THUMB AND FACIAL LACERATIONS. BLOOD WORK AND ECHOCARDIOGRAM. X-RAYS OF HAND AND CHEST. CAT SCAN FOR BRAIN BLEED. DURING FOLLOW-UP CALL ON (B)(6), CONS

  Patient problems: Bone Fracture(s); Electrolyte Imbalance; Fainting; Laceration(s)

  MAUDE report 9819547 ↗