Medline DYND160806Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884389118900), received between Dec 15, 2017 and Sep 17, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Split, Cut or Torn

  It was reported that "The 6ft Medline foley has broken at the Y site junction on 2 occasions while in patients in the PICU."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806910 ↗
• MalfunctionSep 9, 2026Inflation Problem

  It was reported that the balloon is failing to inflate properly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691209 ↗
• InjuryJul 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER ON (B)(6) 2024, "THE BALLOON FILL LINE WOULD NOT ALLOW THE STERILE WATER SYRINGE TO FILL THE BALLOON, EXPERIENCED RESISTANCE. A NEW CATHETER FROM THE SAME LOT WAS INSERTED WITHOUT COMPLICATION.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700411 ↗
• InjuryJul 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, "THE BALLOON FILL LINE WOULD NOT ALLOW THE STERILE WATER SYRINGE TO FILL THE BALLOON, EXPERIENCED RESISTANCE. A NEW CATHETER FROM THE SAME LOT WAS INSERTED WITHOUT COMPLICATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700235 ↗
• InjuryDec 12, 2023Failure to Deflate; Failure to Deflate

  "BALLOON WOULD NOT DEFLATE."

  Patient problems: Foreign Body In Patient

  MAUDE report 18312483 ↗
• MalfunctionMar 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CATHETER RIPPED REQURING REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16488508 ↗
• MalfunctionFeb 17, 2020Material Split, Cut or Torn

  IT WAS REPORTED THAT THE URINARY CATHETER SHAFT TORE WHILE THE URINARY CATHETER WAS INSERTED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717841 ↗
• InjuryDec 15, 2017Break

  IT WAS REPORTED THAT DURING THE REMOVAL OF TEGADERM A FOLEY CATHETER BROKE IN HALF.

  Patient problems: Foreign Body In Patient

  MAUDE report 7122223 ↗