Medline MDS9380Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10080196717743), received between Sep 8, 2026 and Sep 30, 2026 — classified as 107 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (83 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 108 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 50952777 ↗
• MalfunctionSep 30, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948627 ↗
• MalfunctionSep 30, 2026Gas/Air Leak; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948265 ↗
• MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948092 ↗
• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported that "It has a pin hole it will not hold air."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947733 ↗
• MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak

  It was reported that, "It is not pumping air."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947587 ↗
• MalfunctionSep 30, 2026Gas/Air Leak

  This VMSR summarizes one malfunction event involving two Medline Hand Held Aneroids (catalog number MDS9380). This summary report covers malfunction events that occurred between (b)(6), 2025. The account reported that the devices were leaking air. Evaluation of the returned devices confirmed that both units contained bladder leaks that prevented cuff inflation. The affected devices were associated with lot numbers (b)(6) and (b)(6). The issue was confirmed and associated with SCAR-00444 for leakage. No patient information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946616 ↗
• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported that "Leaking air."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946405 ↗
• MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak

  It was reported that the internal bladder of the cuff starts to leak.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946224 ↗
• MalfunctionSep 29, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938496 ↗
• MalfunctionSep 29, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935021 ↗
• MalfunctionSep 29, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933570 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933187 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  It was reported that Sphygmomanometer will not inflate.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927880 ↗
• MalfunctionSep 28, 2026Gas/Air Leak

  This VMSR summary report covers malfunction events that occurred in Q3 of 2025. The report summarizes 8 malfunction events involving Sphygmomanometers (MDS9380). Customer reported that "cuffs are defective, the inflation bulb is not working it gets stuck together while taking blood pressure."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916250 ↗
• MalfunctionSep 28, 2026Gas/Air Leak

  It was reported that "THE BLADDER HAD SPLIT ON THEIR BP CUFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914373 ↗
• MalfunctionSep 25, 2026Material Puncture/Hole; Material Separation; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905932 ↗
• MalfunctionSep 25, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900430 ↗
• MalfunctionSep 25, 2026Calibration Problem

  It was reported that "Item is defective. Will not take accurate BP. Gauge is not working properly."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899116 ↗
• MalfunctionSep 25, 2026Gas/Air Leak; Material Split, Cut or Torn; Physical Resistance/Sticking

  It was reported that "THE BLACK HAND PUMP TO INFLATE THE CUFF IS NO LONGER REINFLATING WHEN RELEASING PRESSURE ON IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898733 ↗
• MalfunctionSep 25, 2026Gas/Air Leak; Material Split, Cut or Torn

  This summary report covers a malfunction event reported to Medline between January 1 and March 31, 2025. This VMSR summarizes one malfunction event involving eight Medline Hand Held Aneroids (catalog number MDS9380). The account reported that the blood pressure cuff bladders split when inflated, causing slow leaks or leaks large enough to render the cuffs unusable. Evaluation of the eight returned devices confirmed that they rapidly deflated and that all eight bladders had tears along the seams. No patient information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897824 ↗
• MalfunctionSep 25, 2026Material Puncture/Hole; Gas/Air Leak

  This summary report covers malfunction events that occurred between (b)(6) 2024. This VMSR summarizes one malfunction event involving three Medline Handheld PVC Aneroids (catalog number MDS9380). The account reported large openings and holes where the tubing connects to the cuffs, causing the cuffs not to inflate or hold pressure. Evaluation of the three returned devices confirmed that all three cuffs leaked near the tubing-to-bladder connection and slowly deflated during testing. No patient information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897661 ↗
• MalfunctionSep 25, 2026High Readings

  It was reported that "The SPHYGMOMANOMETER ANEROID HANDHELD ADULT PVC TUBING FINDER CUFF CARRYING CASE BLACK is not working correctly. I have had 3 clinical staff members try and it is giving a high reading."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897395 ↗
• MalfunctionSep 25, 2026Gas/Air Leak

  It was reported that "The BP cuff does not inflate nor does the needle on the Sphygmomanometer move."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895814 ↗
• MalfunctionSep 24, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886303 ↗