Medline Industries, Inc. URO175816Recalls & reported problems
Medline Industries, Inc. · 1LYRTR 16FR10ML100%SILI UMSNAP · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medline silicone Foley catheter kit, used to drain urine from the bladder. The 36 reports mostly describe the balloon not fully deflating so the catheter had to be cut and removed, urine or air leaking from the balloon port, drainage bag leaks, and the sterile gloves in the kit tearing during use. Twenty reports describe an injury and none describe a death. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10193489987461), received between Apr 4, 2023 and Sep 22, 2026 — classified as 20 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (9 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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem9
- Leak/Splash6
- Material Rupture5
- Break4
- Deflation Problem3
- Detachment of Device or Device Component3
- Fluid/Blood Leak3
- Inflation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information5
- Foreign Body In Patient3
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Genital Bleeding2
- Discomfort1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Fluid/Blood Leak
It was reported that "So far one person has complained that the bag is leaking urine. That she has experienced this happening three times."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855304 ↗MalfunctionSep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828926 ↗MalfunctionSep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828925 ↗MalfunctionSep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828924 ↗MalfunctionSep 10, 2026Break
It was reported that ¿SLIP TIP SPRUNG BROKE OFF IN INFLATION PART.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714214 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675488 ↗MalfunctionSep 7, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658037 ↗MalfunctionJun 2, 2026Failure to Deflate
IT WAS REPORTED THAT "THE NURSE WAS TAKING OUT THE CATHETER" AND "ONLY 9 ML OF STERILE WATER WAS ABLE TO BE PULLED BACK IN THE SYRINGE," INDICATING INCOMPLETE BALLOON DEFLATION. IT WAS FURTHER REPORTED THAT "THE CATHETER WAS THEN CUT AND REMOVED FROM THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25366146 ↗MalfunctionJun 1, 2026Deflation Problem
IT WAS REPORTED THAT UPON DEFLATION OF A CATHETER, "THERE WAS STILL A TINY AMOUNT OF AIR INFLATED IN THE BALLOON".
Patient problems: Genital Bleeding
MAUDE report 25354665 ↗MalfunctionMay 29, 2026Deflation Problem
MalfunctionMay 20, 2026Material Split, Cut or Torn
NURSING EDUCATION SHARED THAT THEY CONTINUE TO GET COMPLAINTS FROM NURSES ABOUT THE STERILE GLOVES RIPPING IN THE FOLEY CATHETER KITS. NURSES HAVE COME ACCUSTOMED TO BRINGING AN ADDITIONAL PAIR OF STERILE GLOVES WHEN THEY USE THESE KITS BECAUSE THE GLOVES IN THE KIT ARE RIPPING SO FREQUENTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237544 ↗MalfunctionMay 5, 2026
MULTIPLE COMPLAINTS: 1. THE NURSE WAS TAKING OUT THE CATHETER. THE NURSE NOTED THAT ONLY 9ML OF STERILE WATER WAS ABLE TO BE PULLED BACK IN THE SYRINGE. THE CATHETER WAS THEN CUT AND REMOVED FROM THE PATIENT. 2. CONNECTED A STERILE SYRINGE TO THE BALLOON PORT AND ALLOWED 9.5ML TO NATURALLY BACKFLOW INTO THE SYRINGE. THEN PULLED BACK WITH THE SYRINGE TO DOUBLE-CHECK IF THERE WAS ANY MORE AIR OR WATER LEFT IN THE BALLOON. PULLED BACK 2 ADDITIONAL TIMES TO VERIFY THERE WAS NOTHING LEFT IN THE BALLOON. CATHETER PULLED OUT WITH NO RESISTANCE. WHEN IT WAS COMPLETELY OUT, THERE WAS STILL A TINY AMOUNT OF AIR INFLATED IN THE BALLOON. PT BLED FROM HIS URETHRA FOR A FEW MINUTES AFTERWARDS AND THEN RESOLVED. 3. REMOVING THE PATIENT'S CATHETER- WITHDREW ALL 10ML OF SALINE, GOT A SECOND SYRINGE, AND DOUBLE-CHECKED THAT I REMOVED IT ALL, THEN PULLED IT. UPON REMOVAL, THERE WAS STILL A SMALL AMOUNT OF SALINE AND/OR AIR LEFT, CAUSING DISCOMFORT TO THE PATIENT AND ULTIMATELY A SMALL AMOUNT OF BLEEDING FROM THE URETHRA.
Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding
MAUDE report 25080737 ↗InjuryJan 23, 2026Break; Leak/Splash
ACCORDING TO THE REPORT, ON (B)(6) 2025, "FOLEY CATHETER LEAKING FROM THE INFLATION PORT. THE SECURE LOCK DEVICE SOMETIMES BREAKS DURING USE."
Patient problems: Insufficient Information
MAUDE report 24167698 ↗MalfunctionDec 9, 2025Leak/Splash; Leak/Splash
CATHETER LEAKING FROM DRAINAGE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756087 ↗InjurySep 8, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE "CATHETER BALLOON RUPTURED INSIDE THE PATIENT, LEAVING A 1.9CM PIECE OF THE CATHETER BALLOON IN THE PATIENT'S BLADDER" AFTER BEING IN PLACE FOR "APPROXIMATELY 1.5 HOURS".
Patient problems: Foreign Body In Patient
MAUDE report 22994088 ↗InjuryJul 17, 2025Material Integrity Problem; Material Integrity Problem
InjuryJul 10, 2025Burst Container or Vessel; Burst Container or Vessel
MalfunctionJul 10, 2025Material Rupture; Material Rupture
A FOLEY CATHETER BALLOON RUPTURED DURING A PROCEDURE. THE FOLEY CATHETER WAS DISCONTINUED AT THE END OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22470443 ↗InjuryJun 13, 2025Contamination /Decontamination Problem; Detachment of Device or Device Component; Contamination /Decontamination Problem; Detachment of Device or Device Component
STOOL IN SAMPLE PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22205745 ↗InjuryJun 13, 2025Device Contamination with Body Fluid; Detachment of Device or Device Component; Device Contamination with Body Fluid; Detachment of Device or Device Component
ACCORDING TO THE FACILITY ON (B)(6) 2025 "PATIENT HAD A STOOL EVENT SO HAD BOTH STOOL INGRESS AND SAMPLE PORT DETACHMENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202372 ↗InjuryMay 27, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn
ACCORDING TO THE FACILITY ON (B)(6) 2025 "AS SOON AS THE REGISTERED NURSE COMPLETED THE FOLEY INSERTION, SHE NOTICED THE PATIENT WAS WET, THE FOLEY HAD SLIPPED OUT OF THE PATIENT AND WHEN SHE EXAMINED THE BALLOON, SHE NOTICED IT WAS SPLIT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22087412 ↗InjuryMay 20, 2025Break; Break
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE SAMPLE PORT "CAME OUT WITH LITTLE TO NO PRESSURE" REQUIRING THE CATHETER TO BE REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055460 ↗InjuryJul 16, 2024Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE FOLEY WAS NOT "WORKING/DRAINING APPROPRIATELY" AND THE PATIENT WAS "NOTED TO BE HAVING LOW URINE OUTPUT AND VOIDING AROUND THE FOLEY".
Patient problems: Urinary Retention
MAUDE report 19756634 ↗InjuryJul 12, 2024Deflation Problem; Deflation Problem
ACCORDING TO THE CUSTOMER, "THE PATIENT HAD A FOLEY INSERTED BY UROLOGIST FOR A ROBOTIC PROSTATECTOMY. THE BALLOON NEEDS TO BE DEFLATED MID-SURGERY FOR REMOVAL AFTER PROSTATE IS EXCISED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19733660 ↗MalfunctionMay 8, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER ON (B)(6), "THE BALLOON DID NOT INFLATE, SECOND FROM THE LOT#. MEDICAL INTERVENTION WAS NECESSARY. NO PATIENT WAS HARMED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19267831 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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