10 Series Upper Arm Blood Pressure Monitor BP7465Recalls & reported problems
Omron Healthcare, Inc. · 10 Series Upper Arm Blood Pressure Monitor with Easy-Wrap ComFit Cuff, 100 memory readings, with blue tooth connectivity, 2 user modes, TruRead, and possible and Atrial Fibrillation Detection. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00073796274658), received between Aug 24, 2026 and Aug 24, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Imprecision” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Imprecision1
Patient problems
- Stroke/CVA1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2026Imprecision
On (b)(6) 2026, the consumer emailed OMRON and stated their blood pressure monitor did not read correctly and they wanted to replace the unit. They stated the unit should still be under warranty and identified the model as BP7465. They stated it read too low. The Consumer Support Team emailed back requesting proof of purchase and further information about the issue.On (b)(6) 2026, the consumer emailed back and attached the receipt. The unit was purchased from (b)(6). The consumer stated that it had been reading very low for a long time. She and her husband believed their blood pressure had improved until her husband experienced a stroke during the previous week. They compared the monitor readings with readings obtained at the hospital and doctor's office. They also took the unit to the doctor's office to compare the readings at the same time. They reviewed the instructions to ensure the monitor was being used correctly. The consumer stated that she believed the OMRON unit was faulty and requested assistance. Based on the additional information provided, the Consumer Support Team emailed a QA Survey to obtain more information about the event. The consumer responded on (b)(6) 2026 an
Patient problems: Stroke/CVA; Visual Impairment
MAUDE report 50420095 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.