Omron 7 Series Connected Upper Arm Blood Pressure Monitor BP7350Recalls & reported problems
Omron Healthcare, Inc. · Upper arm blood pressure monitor with Bluetooth connectivity, 2 user modes and 60 readings per user. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00073796267353), received between Mar 18, 2024 and Mar 20, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Melted” (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.
Reports received per month
Most reported problems
Device problems
- Melted2
- Smoking2
- Sparking2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2024Melted; Smoking; Sparking; Melted; Smoking; Sparking
THE CONTACT PERSON CALLED ON BEHALF OF THE USER WHO EXPERIENCED THE EVENT. THEY STATED THEIR PARTNER HAD MULTIPLE PHYSICAL ILLNESSES AND NEEDED AN AUTOMATIC BLOOD PRESSURE MONITOR FOR FREQUENT READINGS. THE MACHINE WAS PURCHASED FROM A NEARBY WALGREENS. THEY STATED THE MONITOR LASTED LESS THAN A MONTH. DURING THE EVENT, THE USER TRIED TO TAKE A BLOOD PRESSURE READING AND THE MONITOR STARTED SMOKING AND SPARKING. THE USER'S FATHER UNPLUGGED THE MACHINE FROM THE USER'S ARM AND TOOK THE BATTERIES OUT OF THE MONITOR. IT HAD BURN DAMAGE AND OTHER VARIOUS BURN MARKS ON THE MACHINE. A FEW ATTEMPTS WERE MADE AFTER THE INITIAL CALL TO GET IN CONTACT WITH THE CONSUMER AND GET ADDITIONAL INFORMATION. THE CONSUMER RESPONDED ON (B)(6) 2024. THEY STATED THAT THE USER WAS 24 YEARS OLD. THEY HAD THE UNIT FOR 2 WEEKS AND THE UNIT IS USED 4 TIMES A DAY WHEN USER WOULD TAKE HER MEDICATIONS. THE EVENT OCCURRED ON 3/7/2024. THERE WAS ONLY ONE PERSON WHO USED THE MONITOR. WHEN TAKING A READING, THE USER WOULD SIT AT THE KITCHEN TABLE WITH THE MONITOR PLACED FLAT ON THE TABLE. SHE USED HER LEFT ARM. HER ARM CIRCUMFERENCE WAS 14 INCHES. THE CUFF WAS SNUG ON THE ARM AND TWO FINGERS CAN BE WEDGED UNDER IT W
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18946960 ↗MalfunctionMar 18, 2024Melted; Smoking; Sparking; Melted; Smoking; Sparking
THE CONTACT PERSON CALLED ON BEHALF OF THE USER WHO EXPERIENCED THE EVENT. THEY STATED THEIR PARTNER HAD MULTIPLE PHYSICAL ILLNESSES AND NEEDED AN AUTOMATIC BLOOD PRESSURE MONITOR FOR FREQUENT READINGS. THE MACHINE WAS PURCHASED FROM A NEARBY WALGREENS. THEY STATED THE MONITOR LASTED LESS THAN A MONTH. DURING THE EVENT, THE USER TRIED TO TAKE A BLOOD PRESSURE READING AND THE MONITOR STARTED SMOKING AND SPARKING. THE USER'S FATHER UNPLUGGED THE MACHINE FROM THE USER'S ARM AND TOOK THE BATTERIES OUT OF THE MONITOR. IT HAD BURN DAMAGE AND OTHER VARIOUS BURN MARKS ON THE MACHINE. A FEW ATTEMPTS WERE MADE AFTER THE INITIAL CALL TO GET IN CONTACT WITH THE CONSUMER AND GET ADDITIONAL INFORMATION. THE CONSUMER RESPONDED ON 3/13/2024. THEY STATED THAT THE USER WAS 24 YEARS OLD. THEY HAD THE UNIT FOR 2 WEEKS AND THE UNIT IS USED 4 TIMES A DAY WHEN USER WOULD TAKE HER MEDICATIONS. THE EVENT OCCURRED ON 3/7/2024. THERE WAS ONLY ONE PERSON WHO USED THE MONITOR. WHEN TAKING A READING, THE USER WOULD SIT AT THE KITCHEN TABLE WITH THE MONITOR PLACED FLAT ON THE TABLE. SHE USED HER LEFT ARM. HER ARM CIRCUMFERENCE WAS 14 INCHES. THE CUFF WAS SNUG ON THE ARM AND TWO FINGERS CAN BE WEDGED UNDER IT WHE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18924822 ↗
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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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