Medline DYND11756Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10080196726523), received between Feb 25, 2019 and Sep 4, 2026 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (4 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 4, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611459 ↗
• MalfunctionSep 3, 2026Decoupling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595787 ↗
• MalfunctionSep 3, 2026Failure to Deflate

  It was reported that "During routine indwelling Foley catheter exchange old catheter balloon would not deflate. Luer lock syringe used would be pulled back and canal to balloon would visibly deflate with no liquid return. Catheter remained anchored and could not be removed."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589099 ↗
• MalfunctionJun 17, 2026Failure to Deflate

  IT WAS REPORTED THAT BALLOONS WERE NOT FULLING DEFLATING INSIDE PATIENT'S BLADDER.

  Patient problems: Insufficient Information

  MAUDE report 25540696 ↗
• InjuryOct 16, 2025Break; Obstruction of Flow; Break; Obstruction of Flow

  ACCORDING TO THE CUSTOMER, "THE CATHETER WAS NOT DRAINING.". THE NOZZLE WAS REPLACED, THEN LATER IT WAS NOTICED THAT "THE VALVE BROKE OFF INSIDE THE PATIENT.". THE CUSTOMER WENT TO THE EMERGENCY ROOM, AN ULTRASOUND WAS PERFORMED AND "THEY COULD SEE THE PIECE OF CATHETER WAS STILL INSIDE THE BLADDER.". CUSTOMER WAS ADMITTED TO THE HOSPITAL AND SUBSEQUENTLY HAD A CYSTOSCOPY DONE TO REMOVE THE PIECE OF CATHETER.

  Patient problems: Foreign Body In Patient; Urinary Retention

  MAUDE report 23317159 ↗
• MalfunctionSep 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER HAD COME OUT OF THE PATIENT AND WAS NOTED TO BE BROKEN IN HALF WITH THE BALLOON INTACT. A NEW CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955546 ↗
• InjuryJul 31, 2025Deflation Problem; Failure to Deflate; Deflation Problem; Failure to Deflate

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THEY HAD TO GO TO THE EMERGENCY DEPARTMENT TO HAVE THEIR FOLEY CATHETER BALLOON DEFLATED AND REPLACED WHEN THE NURSE COULD NOT DEFLATE THE BALLOON IN THE HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676601 ↗
• InjuryJul 31, 2025Failure to Deflate; Failure to Deflate

  ACCORDING TO THE CUSTOMER, THE FOLEY CATHETER BALLOON FAILED TO DEFLATE AND THE CUSTOMER HAD TO HAVE THE BALLOON DEFLATED IN THE EMERGENCY ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675366 ↗
• MalfunctionMay 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  BALLOON WOULD NOT DEFLATE.

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

  MAUDE report 22105182 ↗
• InjuryDec 11, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER, WITHIN THE "LAST 3 MONTHS" THE FOLEYS ARE "FREQUENTLY LEAKING URINE" AFTER BEING INSERTED BETWEEN "A FEW DAYS TO A WEEK", CAUSING THE PATIENT'S BRIEFS TO BECOME "HEAVILY SOILED".

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

  MAUDE report 20903967 ↗
• MalfunctionAug 9, 2024Material Integrity Problem; Material Integrity Problem

  "FOLEY BALLOON BLEW UP AFTER INSERTING THE ITEM".

  Patient problems: Insufficient Information

  MAUDE report 19949416 ↗
• InjuryFeb 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CATHETER LEAKED REQUIRING ADDITIONAL CATHETER TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279913 ↗
• MalfunctionSep 14, 2020Break

  IT WAS REPORTED THAT A SILICONE ELASTOMER COATED LATEX FOLEY CATHETER BROKE INTO PIECES UPON REMOVAL. A NEW CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10532600 ↗
• MalfunctionOct 15, 2019Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT PROPERLY INFLATE RESULTING IN THE CATHETER NOT SECURING AND THE END USER EXPERIENCING URINARY RETENTION.

  Patient problems: Urinary Retention; Urinary Tract Infection

  MAUDE report 9191949 ↗
• MalfunctionApr 9, 2019Complete Blockage

  IT WAS REPORTED THAT AN UNIDENTIFIED NUMBER OF FOLEY CATHETERS ARE "CLOGGING VERY FREQUENTLY" REQUIRING TO BE CHANGED TWICE IN A SHIFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8495375 ↗
• MalfunctionFeb 25, 2019Deflation Problem

  IT WAS REPORTED THAT THE URINARY CATHETER BALLOON WAS UNABLE TO BE DEFLATED DURING REMOVAL.

  Patient problems: Unspecified Infection

  MAUDE report 8366252 ↗