Medline URO170816Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10888277862623), received between Mar 26, 2019 and Sep 23, 2026 — classified as 13 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that "10ml normal saline syringe in the foley kit that snapped off when connected to the connector. We had to use forceps to remove the tip of it."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867954 ↗
• MalfunctionSep 16, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794604 ↗
• MalfunctionSep 11, 2026Break

  It was reported that 1 EA Syringe tip broken from lot: 23ABR985.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733089 ↗
• MalfunctionSep 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50720547 ↗
• InjuryApr 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER ON 3/15, "A FOLEY WAS INSERTED BEFORE THE START OF A ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY AND THE BALLOON WAS FOUND TO HAVE BEEN RUPTURED WHEN SCRUB TECH AND RN WERE GOING TO DO A BLADDER BACK FILL.

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

  MAUDE report 19106756 ↗
• InjuryApr 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, ON 01/26/2024 WHEN INSERTING THE CATHETER, IT "SLID OUT RIGHT AWAY" AND WAS IN PLACE FOR "MINUTES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106074 ↗
• InjuryApr 15, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER, THE FOLEY CATHETER WAS LEAKING AND HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105901 ↗
• InjuryApr 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE PATIENT WAS "BEING ROLLED" AND THE CATHETER "CAME OUT" AFTER BEING IN PLACE FOR A "COUPLE HOURS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105710 ↗
• InjuryMar 25, 2024Material Integrity Problem; Material Integrity Problem

  FOLEY BALLOON RUPTURED WHILE IN PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18970650 ↗
• InjuryJan 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER ON 1/3/2024, THE FOLEY CATHETER "CAME OUT OF THE URETHRA" AFTER INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580549 ↗
• InjuryMar 30, 2023Leak/Splash; Leak/Splash

  ACCORDING TO THE FACILITY ON (B)(6) 2023 THE FOLEY CATHETER AND THE UROMETER COLLECTION DEVICE WAS LEAKING. PER THE FACILITY THE DEVICE WAS REMOVED AND THE FOLEY CATHETER WAS REPLACED.

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

  MAUDE report 16645373 ↗
• InjuryMar 21, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY ON (B)(6) 2023THE SAMPLE PORT DETACHED FROM THE FOLEY CATHETER, REQUIRING THE FACILITY TO REMOVE AND REPLACE THE FOLEY CATHETER.

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

  MAUDE report 16583541 ↗
• MalfunctionFeb 22, 2023Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT PULLED OUT THE FOLEY CATHETER WITH THE BALLOON INFLATED WHICH RESULTED IN THE BALLOON SHREDDING. A NEW CATHETER WAS PLACED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417946 ↗
• InjuryOct 31, 2022Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY ON (B)(6) 2022 THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM FOR A PROCEDURE AND A FOLEY CATHETER WAS PLACED AFTER THE PATIENT WAS POSITIONED. PER THE FACILITY UPON DRAPING THE PATIENT THE FOLEY CATHETER CAME OUT AND UPON INSPECTION THE BALLOON WAS BUSTED.

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

  MAUDE report 15700103 ↗
• InjuryJun 23, 2022Break

  ACCORDING TO THE FACILITY ON 5/24 THE TIP OF A CATHETER BROKE OFF IN A PATIENT AT THE TIME OF REMOVAL.

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

  MAUDE report 14789161 ↗
• InjuryApr 21, 2022Material Rupture; Device Fell

  ACCORDING TO THE FACILITY DURING A PROCEDURE THE FOLEY CATHETER BALLOON 'BURST INSIDE PATIENT AND FELL OUT'.

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

  MAUDE report 14168423 ↗
• InjuryApr 21, 2022Material Rupture; Device Fell

  ACCORDING TO THE FACILITY DURING A PROCEDURE THE FOLEY CATHETER BALLOON 'BURST INSIDE PATIENT AND FELL OUT'.

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

  MAUDE report 14168129 ↗
• InjuryApr 21, 2022Material Rupture; Device Fell

  ACCORDING TO THE FACILITY DURING A PROCEDURE THE FOLEY CATHETER BALLOON 'BURST INSIDE PATIENT AND FELL OUT'.

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

  MAUDE report 14167881 ↗
• MalfunctionJan 10, 2022Unintended Deflation

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER DEFLATED. A NEW FOLEY WAS REINSERTED WITHOUT FURTHER ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13210582 ↗
• MalfunctionJul 22, 2019Deflation Problem

  IT WAS REPORTED THAT SALINE WAS USED TO INFLATE THE FOLEY CATHETER BALLOON AND THE BALLOON COULD ONLY BE FILLED TO 5 ML. THE BALLOON WAS THEN REPORTEDLY UNABLE TO BE DEFLATED AND A NEEDLE WAS USED TO SUCCESSFULLY DEFLATE THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812518 ↗
• MalfunctionJun 28, 2019Break; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SYRINGE TIP BROKE OFF INTO THE URINARY CATHETER'S BALLOON INFLATION PORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743848 ↗
• MalfunctionMar 26, 2019Leak/Splash

  IT WAS REPORTED THAT THE URINARY CATHETER WAS LEAKING. THE URINARY CATHETER WAS REMOVED AND REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453785 ↗