Medline URO170816SRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10889942126828), received between Jun 27, 2018 and Sep 12, 2026 — classified as 7 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2026Break; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746730 ↗
• MalfunctionSep 11, 2026Material Puncture/Hole; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736857 ↗
• InjurySep 17, 2025Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  ACCORDING TO THE FACILITY, ON (B)(6) 2025, IT WAS NOTICED THAT THE FOLEY CATHETER WAS NOT DRAINING PROPERLY AND LEAKING AROUND THE CATHETER INSERTION SITE. THE CATHETER WAS REMOVED AND THE PATIENT WAS STRAIGHT CATHETERIZED WITH LARGE AMOUNTS OF URINE COLLECTED. FACILITY REPORTS NO SERIOUS INJURY. INDIVIDUAL IS DOING "FINE".

  Patient problems: Urinary Retention

  MAUDE report 23078659 ↗
• InjurySep 17, 2025Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  ACCORDING TO THE FACILITY, ON (B)(6) 2025, IT WAS NOTICED THAT THE FOLEY CATHETER WAS NOT DRAINING PROPERLY AND LEAKING AROUND THE CATH INSERTION SITE. CATHETER WAS REMOVED AND THEN PATIENT WAS STRAIGHT CATHED WITH LARGE AMOUNT OF URINE COLLECTED. FACILITY REPORTS NO SERIOUS INJURY. INDIVIDUAL IS DOING "FINE."

  Patient problems: Urinary Retention

  MAUDE report 23078049 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED THAT URINE WAS LEAKING AROUND THE FOLEY. THE FOLEY WAS DISCONTINUED AND THE PATIENT WAS STRAIGHT CATHETERIZED. 1,800 ML OF URINE WAS DRAINED.

  Patient problems: Urinary Retention

  MAUDE report 23075014 ↗
• InjuryNov 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE FOLEY "CAME OUT WHEN PATIENT WAS FLIPPED INTO THE PRONE POSITION" DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604649 ↗
• MalfunctionOct 31, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE FOLEY "CAME OUT WHEN PATIENT WAS FLIPPED INTO THE PRONE POSITION" DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577687 ↗
• MalfunctionOct 30, 2024Material Integrity Problem; Material Integrity Problem

  BALLOON NOT INTACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570226 ↗
• InjuryMar 29, 2024Break; Break

  ACCORDING TO THE CUSTOMER, THE "SAMPLING PORT ON THE FOLEY CATHETER BROKE WHILE ATTEMPTING TO OBTAIN URINE SAMPLE WITH SYRINGE", A NEW CATHETER WAS INSERTED, AND THE NEW CATHETER SAMPLE PORT "DETACHED COMPLETELY FROM THE CATHETER, WHICH CREATED AN OPENING IN THE CATHETER TUBING" WHEN REMOVING A SYRINGE FROM THE PORT.

  Patient problems: Urinary Tract Infection

  MAUDE report 19004295 ↗
• InjuryMar 29, 2024Break; Break

  ACCORDING TO THE CUSTOMER, THE "SAMPLING PORT ON THE FOLEY CATHETER BROKE WHILE ATTEMPTING TO OBTAIN URINE SAMPLE WITH SYRINGE", A NEW CATHETER WAS INSERTED, AND THE NEW CATHETER SAMPLE PORT "DETACHED COMPLETELY FROM THE CATHETER, WHICH CREATED AN OPENING IN THE CATHETER TUBING" WHEN REMOVING A SYRINGE FROM THE PORT.

  Patient problems: Urinary Tract Infection

  MAUDE report 19004228 ↗
• MalfunctionFeb 13, 2024Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE CUSTOMER ON (B)(6) 2023, "THE RN WAS MOVING THE FOLEY TUBING TO HELP IT DRAIN, AND THE CATHETER CAME OUT OF THE PT'S URETHRA".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699258 ↗
• MalfunctionOct 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  LEAKING FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895235 ↗
• MalfunctionOct 9, 2023Unintended Movement; Unintended Movement

  FOLEY CAME OUT WITH BALLOON INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894844 ↗
• MalfunctionAug 5, 2022Burst Container or Vessel

  IT WAS REPORTED THAT THE NURSE ATTEMPTED TO PLACE A FOLEY CATHETER IN A PATIENT AND AFTER THE NURSE PUT MORE THAN 5ML'S IN THE BALLOON THE BALLOON EXPLODED. A NEW DEVICE WAS REQUIRED TO BE PLACED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174161 ↗
• InjuryJul 30, 2022Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NURSE ATTEMPTED TO PLACE A FOLEY CATHETER IN A PATIENT AND AFTER COMPLETING THE PROCEDURE, INFLATED THE BALLOON WITH 10MLS AND PULLED BACK ON THE CATHETER THE CATHETER JUST CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136756 ↗
• MalfunctionFeb 24, 2022Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INPATIENT WITH URINARY RETENTION HAD A URINARY CATHETER INSERTED. THE REGISTERED NURSE REPORTED THE CATHETER BECAME DISLODGED AND ANOTHER CATHETER WAS REQUIRED TO BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592412 ↗
• MalfunctionMar 23, 2021Material Rupture

  IT WAS REPORT "THE BALLOON POPPED AFTER INSERTION AS IT WAS BEING INFLATED." A SECOND FOLEY CATHETER WAS THEN TESTED AND IT TOO BURST BEFORE IT WAS FULLY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556531 ↗
• MalfunctionMay 15, 2020Material Rupture; Device Slipped

  IT WAS REPORTED THE CATHETER BALLOON RUPTURED AND THE CATHETER SLID OUT. IT WAS REPLACED WITH ANOTHER CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063406 ↗
• MalfunctionNov 26, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT THE ENTIRE FOLEY CATHETER SYSTEM (CATHETER AND DRAINAGE BAG) HAD TO BE REPLACED AFTER LEAKING WAS NOTED COMING FROM THE SLIDING CLAMP OF THE DRAINAGE BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9375673 ↗
• MalfunctionNov 26, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT THE ENTIRE FOLEY CATHETER SYSTEM (CATHETER AND DRAINAGE BAG) HAD TO BE REPLACED AFTER LEAKING WAS NOTED COMING FROM THE SLIDING CLAMP OF THE DRAINAGE BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9375537 ↗
• MalfunctionJun 27, 2019Device Dislodged or Dislocated; Device Fell

  IT WAS REPORTED THAT PATIENT'S FOLEY CATHETER "FELL OUT" AND PATIENT REQUIRED FOLEY CATHETER EXCHANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8741024 ↗
• MalfunctionJun 27, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S FOLEY CATHETER HAD "FALLEN OUT AGAIN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739843 ↗
• InjuryDec 28, 2018Leak/Splash

  IT WAS REPORTED THAT A FOLEY CATHETER EXPERIENCED A LEAK IN THE BALLOON AND WAS REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8202399 ↗
• MalfunctionJun 27, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH FOLEY CATHETER IN PLACE, WHO WAS IN LABOR, DEVELOPED BLADDER DISTENTION AND ARREST OF CERVICAL DILATION.

  Patient problems: No Code Available

  MAUDE report 7641547 ↗