Medline DYND11552Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884389034415), received between Apr 20, 2018 and Mar 25, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (5 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. May 28, 2019Terminated

   Loose silicone particulate was found to be present on the shaft of the silicone catheters.

   Z-2042-2020 · Root cause: Manufacturing material removal · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Material Integrity Problem

  FOLEY WAS FOUND TO HAVE SNAPPED AT CONNECTION POINT TO THE Y BETWEEN THE DRAINAGE BAG AND THE BALLOON, CAUSING RUPTURE OF BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686905 ↗
• MalfunctionJan 29, 2024Inflation Problem; Inflation Problem

  BALLOON DIDN'T INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595706 ↗
• InjuryDec 1, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY THE FOLEY CATHETER FELL OUT OF THE PATIENT AND REQUIRED REINSERTION WITH A NEW CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18248526 ↗
• MalfunctionJul 17, 2023Material Integrity Problem; Material Integrity Problem

  CATHETER BROKE AT TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333735 ↗
• MalfunctionAug 25, 2020Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THE FOLEY CATHETER "SNAPPED OFF ABOVE THE BALLOON PORT WHILE STILL SECURED WITH DRESSING IN THE PATIENT." CATHETER WAS REPORTED TO BE LEAKING. CATHETER REMOVED AND REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451871 ↗
• MalfunctionAug 1, 2018Leak/Splash

  IT WAS REPORTED THAT A NEW FOLEY CATHETER WAS INSERTED AFTER THE FOLEY CATHETER'S BALLOON WAS NOTED LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7740927 ↗
• MalfunctionApr 23, 2018Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON, WHICH WAS FILLED WITH AIR, WOULD NOT HOLD INFLATION WHILE IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7451690 ↗
• MalfunctionApr 23, 2018Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON, WHICH WAS FILLED WITH AIR, WOULD NOT HOLD INFLATION WHILE IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7451563 ↗
• MalfunctionApr 20, 2018Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON, WHICH WAS FILLED WITH AIR, WOULD NOT HOLD INFLATION WHILE IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7448139 ↗
• MalfunctionApr 20, 2018Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON, WHICH WAS FILLED WITH AIR, WOULD NOT HOLD INFLATION WHILE IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7447816 ↗