Medline MDS9407Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 40080196771333), received between Sep 11, 2026 and Sep 30, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953728 ↗
• MalfunctionSep 30, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951740 ↗
• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported that "CUSTOMER HAS BEEN HAVING ISSUES WITH THE CUFF LEAKING AIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947940 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932175 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "This item does not work properly, the readings a=e not accurate.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916703 ↗
• MalfunctionSep 25, 2026High Readings

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902926 ↗
• MalfunctionSep 25, 2026Gas/Air Leak

  It was reported that "bad adult size cuff, will not pump up."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900697 ↗
• MalfunctionSep 24, 2026Material Puncture/Hole; Gas/Air Leak

  This VMSR report summarizes 2 malfunction events that occurred between (b)(6) and (b)(6), 2025. The account reported that mobile aneroid blood pressure monitors (MDS9407) produced hissing noises and were unable to obtain blood pressure readings due to inflation failure. No patient information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884885 ↗
• MalfunctionSep 23, 2026Calibration Problem

  It was reported that "The dial will not register at bottom center \"0\" Therefore Med-Surg is not able to get accurate reading on patients."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872150 ↗
• MalfunctionSep 23, 2026Incorrect Measurement

  It was reported that "The issue is the unit is Its measuring 5-6 mmhgs off."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871838 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "ITEM IS DEFECTIVE AS NEEDLE KEEPS GETTING STUCK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871170 ↗
• MalfunctionSep 23, 2026Gas/Air Leak

  It was reported that both machines have tiny holes in the cuff itself. You can hear the pressure increasing but the air is escaping from the cuff.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870039 ↗
• MalfunctionSep 23, 2026Calibration Problem

  It was reported that "one of the machines is not operable (from day 1). It will not go to zero on the manometer."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868974 ↗
• MalfunctionSep 23, 2026Break; Unable to Obtain Readings; Failure to Disconnect

  It was reported that "2 CONNECTORS WERE NEVER ABLE TO PULL CONNECTORS APART WHEN PUMPING UP CUFF THE NEDDLE DOES NOT MOVE AND AIR WILL NOT RELEASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868191 ↗
• MalfunctionSep 23, 2026Calibration Problem

  It was reported that "First time that this BP unit was used the hand got stuck on 240."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867010 ↗
• MalfunctionSep 22, 2026Calibration Problem

  It was reported that gauge pin gets stuck in one position (at around 120~140 psi).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857195 ↗
• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "DAVID CI HAVING ISSUES W BP MONITOR. HE STATES READINGS ARE INNACURATE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856430 ↗
• MalfunctionSep 21, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848039 ↗
• MalfunctionSep 21, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847014 ↗
• MalfunctionSep 21, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839299 ↗
• MalfunctionSep 19, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831841 ↗
• MalfunctionSep 18, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827689 ↗
• MalfunctionSep 18, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825956 ↗
• MalfunctionSep 18, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824719 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820692 ↗