Medline MDS9973Recalls & reported problems
Medline Industries, Inc. · CUFF,BP,EXTRA LARGE ADULT, FOR MDS3001 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196721900), received between Sep 11, 2026 and Sep 29, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Inflation Problem2
- Unable to Obtain Readings2
- Gas/Air Leak1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Inflation Problem; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936785 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that the product was "Not working properly, goes too tight on the arm and doesn't allow for proper reading on blood pressure monitors."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899511 ↗MalfunctionSep 11, 2026Inflation Problem; Unable to Obtain Readings
It was reported that "The BP cuff is not working properly.From what I¿ve gathered from our clinical team they press start to check blood pressure and it does not trigger the cuff to tighten."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736886 ↗MalfunctionSep 11, 2026Unable to Obtain Readings
It was reported that the blood pressure cuff gets no results, it goes through the process of taking the readings, but no results come at the end.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732876 ↗
Other SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE devices
- Medline MDS5001Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive747 reports
- Medline MDS4003Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive398 reports
- Medline MDS4001Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive267 reports
- Medline MDS3001UMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive170 reports
- Medline MDS1001CSMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive1 recall57 reports
- Ultraview SL Ultraview SL®Spacelabs Healthcare (Washington), Inc · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE2 recalls2 reports
- DTX(TM) PLUS DT-4812 682000Argon Critical Care Systems Singapore Pte. Ltd. · System, Measurement, Blood-Pressure, Non-Invasive86 reports
- Medline MDS7001BMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive81 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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