Medline DYND11523Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884389497296), received between Mar 21, 2024 and Sep 30, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (6 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Product Quality Problem; Unintended Deflation

  Patient problems: Pain

  MAUDE report 50951244 ↗
• MalfunctionSep 30, 2026Product Quality Problem; Unintended Deflation

  Patient problems: Pain

  MAUDE report 50951234 ↗
• MalfunctionSep 18, 2026Inflation Problem

  It was reported that "We had two of these, that the balloon didn¿t work".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819831 ↗
• MalfunctionSep 18, 2026Inflation Problem

  It was reported that "balloons are not inflating or popping."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813088 ↗
• MalfunctionSep 17, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812164 ↗
• MalfunctionSep 17, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812160 ↗
• MalfunctionSep 15, 2026Inflation Problem

  It was reported that "The attached catheter tray was defective, the balloon wouldn¿t inflate at all."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772251 ↗
• MalfunctionSep 11, 2026Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740400 ↗
• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697432 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak

  It was reported that "The customer has had multiple kits that are leaking in use".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695730 ↗
• MalfunctionSep 8, 2026Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675708 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670047 ↗
• MalfunctionDec 23, 2025Unintended Deflation; Unintended Deflation

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE CATHETER WAS FOUND TO BE "NOT DRAINING" AND THE "BALLOON HAD DEFLATED" RESULTING IN THE CATHETER BEING REPLACED. THE CUSTOMER REPORTED THAT THIS SAME PATIENT "HAD TO HAVE 3 FOLEYS REPLACED" IN TOTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882335 ↗
• MalfunctionDec 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  SYRINGE FILLED WITH AIR, NOT WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830366 ↗
• MalfunctionDec 17, 2025Inflation Problem; Inflation Problem

  FOLEY CATHETER BALLOON DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829180 ↗
• MalfunctionMar 21, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE SYRINGE COULD NOT ATTACH TO A PORT ON THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954391 ↗