Medline DYND11519Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10080196809790), received between Dec 9, 2019 and Sep 29, 2026 — classified as 10 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936144 ↗
• MalfunctionSep 25, 2026Fluid/Blood Leak

  It was reported that "We are having a problem with the valve leaking on all of the bags that are in our catheter kits that we have purchased."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899129 ↗
• MalfunctionSep 10, 2026Failure to Disconnect

  It was reported that "The catheter is increasingly hard to pull out of the tubing if the catheter were needed to be replaced."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714368 ↗
• MalfunctionJan 16, 2026Inflation Problem

  ACCORDING TO THE FACILITY, ON (B)(6) 2025, A PATIENT WAS UNDERGOING A LAPAROSCOPIC APPENDECTOMY. AFTER INDUCTION OF GENERAL ANESTHESIA AND PATIENT POSITIONING, THE FOLEY CATHETER FROM THE STERILE KIT WAS OPENED THE SURGEON INSERTED THE CATHETER INTO THE URETHRA AND ATTEMPTED TO INFLATE THE BALLOON WITH 10 ML OF STERILE WATER SUPPLIED IN THE KIT. NO RESISTANCE WAS FELT WHEN THE SURGEON WAS DRAWING THE CATHETER BACK AND SUBSEQUENTLY REMOVED IT FROM THE PATIENT. IT WAS OBSERVED THAT THE BALLOON HAD NOT INFLATED. THE CATHETER TIP SHOWED NO VISIBLE HOLES OR FRAYING. A REPLACEMENT FOLEY CATHETER WAS INSERTED WITHOUT ISSUE. THE PRODUCT REQUIRED REPLACEMENT: HOWEVER, NO PATIENT INJURY, NO ADDITIONAL MEDICAL INTERVENTION, AND NO FOLLOW UP CARE WERE REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094909 ↗
• InjuryNov 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, "HE WAS LYING IN BED WATCHING TV AND HE FELT THE POP OF THE BALLOON INSIDE."

  Patient problems: Discomfort

  MAUDE report 20622452 ↗
• InjuryOct 31, 2024Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE CUSTOMER ON 10/3, THE PATIENT WAS SITTING ON THE TOILET AND HAVING A BOWEL MOVEMENT AND HE FELT A POP INSIDE AND THE FOLEY CAME OUT.

  Patient problems: Burning Sensation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20577907 ↗
• MalfunctionOct 29, 2024Material Integrity Problem; Material Integrity Problem

  FOLEY BALLOON BURST.

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

  MAUDE report 20562259 ↗
• InjuryJul 6, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE CUSTOMER, THE FOLEY HAD FALLEN OUT OF THE PATIENT DUE TO A "SMALL PINHOLE LEAK" WHICH WAS NOTED WHEN THE FLUID WAS "RE- INSTILLED INTO THE BALLOON".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19685895 ↗
• InjuryJun 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY THE FOLEY CATHETERS BALLOON HAS RUPTURED AND THE FOLEY CATHETER HAD COME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605660 ↗
• InjuryApr 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RUPTURED BULB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135271 ↗
• InjuryApr 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  WHEN PATIENT STOOD AFTER PLACEMENT, THE CATHETER FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134351 ↗
• MalfunctionOct 31, 2023Material Integrity Problem; Material Integrity Problem

  "BALLOONS DEFLATING".

  Patient problems: Insufficient Information

  MAUDE report 18038963 ↗
• MalfunctionOct 30, 2023Infusion or Flow Problem; Infusion or Flow Problem

  "CATHETERS CLOGGING & DIFFICULT TO DISCONNECT".

  Patient problems: Insufficient Information

  MAUDE report 18031536 ↗
• InjuryMar 28, 2023Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER ON (B)(6) 2023 THERE WAS "LEAKAGE FROM AROUND THE TUBING" OF THE FOLEY CATHETER AFTER BEING IN PLACE FOR A DAY. THE CUSTOMER REPORTED A NEW CATHETER WAS PLACED.

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

  MAUDE report 16627442 ↗
• InjurySep 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2022 A HOME HEALTH NURSE WAS CALLED TO REPLACE A MEDLINE FOLEY CATHETER THAT WAS PLACED EARLIER THAT DAY, AND WOULD NOT DRAIN.

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

  MAUDE report 15404824 ↗
• InjuryDec 8, 2021Burst Container or Vessel; Device Slipped

  IT WAS REPORTED THAT THE INDWELLING FOLEY CATHETER BALLOON BURST WHILE INSERTED IN THE PATIENT. THE CATHETER FELL OUT OF THE PATIENT AND WAS REPLACED WITH A NEW CATHETER.

  Patient problems: Discomfort

  MAUDE report 12964817 ↗
• MalfunctionOct 7, 2021Device Fell

  IT WAS REPORTED, "A CATHETER HAD FALLEN OUT." A NEW CATHETER WAS PLACED THE FOLLOWING AFTERNOON."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591297 ↗
• InjuryFeb 24, 2021Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD A CATHETER IN PLACE FOR TWO DAYS AND THE CATHETER CAME OUT ON ITS OWN AFTER THE BALLOON POPPED. THE CATHETER WAS REPLACED WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371969 ↗
• MalfunctionJan 14, 2021Fluid/Blood Leak

  IT WAS REPORTED THE FOLEY CATHETER WAS LEAKING AND REQUIRED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11171582 ↗
• MalfunctionMar 23, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THE URINARY CATHETER BALLOON LEAKED DURING INFLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865716 ↗
• MalfunctionMar 23, 2020Material Rupture

  IT WAS REPORTED THAT THE URINARY CATHETER BALLOON FULLY DEFLATED AFTER INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865087 ↗
• MalfunctionDec 9, 2019Inflation Problem

  IT WAS REPORTED THAT AFTER BEING INSERTED INTO THE PATIENT, THE URINARY CATHETER BALLOON WOULD NOT INFLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440235 ↗
• MalfunctionDec 9, 2019Inflation Problem

  IT WAS REPORTED THAT AFTER BEING INSERTED INTO THE PATIENT, THE URINARY CATHETER BALLOON WOULD NOT INFLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440067 ↗
• MalfunctionDec 9, 2019Inflation Problem

  IT WAS REPORTED THAT AFTER BEING INSERTED INTO THE PATIENT, THE URINARY CATHETER BALLOON WOULD NOT INFLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437055 ↗