Medline Industries, Inc. URO175716Recalls & reported problems
Medline Industries, Inc. · 1LYRTR 16FR10ML 100%SILI SNAP · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10193489987423), received between Apr 1, 2024 and Sep 30, 2026 — classified as 5 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (6 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 Rupture6
- Inflation Problem4
- Fluid/Blood Leak3
- Material Integrity Problem3
- Burst Container or Vessel2
- Device Dislodged or Dislocated2
- Obstruction of Flow2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Burning Sensation1
- Laceration(s)1
- Perineal injury1
- Urinary Retention1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that "a patient came to us twice in the last 2 weeks due to issues with his foley drainage bag leaking. It is leaking where the drainage spout folds up."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941748 ↗MalfunctionSep 28, 2026Unintended Deflation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923817 ↗MalfunctionSep 18, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822836 ↗MalfunctionSep 18, 2026Material Rupture; Device Dislodged or Dislocated
Found catheter lying in the patient's bed while providing wound care. Upon inspection, the balloon appeared to have popped, causing the catheter to fall out.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816789 ↗MalfunctionSep 15, 2026Inflation Problem
It was reported that "The Balloons would not inflate on catheter."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776886 ↗MalfunctionSep 14, 2026Material Puncture/Hole; Material Split, Cut or Torn
It was reported that "The first ballon did not inflate the second ballon fell apart."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754850 ↗MalfunctionSep 11, 2026Material Rupture
Patient problems: Urinary Retention
MAUDE report 50739814 ↗MalfunctionSep 9, 2026Inflation Problem; Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695150 ↗MalfunctionSep 9, 2026Inflation Problem
It was reported that "The Balloons would not inflate on catheter."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50689606 ↗MalfunctionSep 8, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675484 ↗MalfunctionSep 8, 2026Inflation Problem
Patient problems: Insufficient Information
MAUDE report 50673858 ↗MalfunctionSep 8, 2026Break
It was reported that while prepping the catheter for insertion the syringe tip broke of in the balloon port.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50673366 ↗MalfunctionAug 21, 2026Fluid/Blood Leak; Obstruction of Flow
It was reported that the catheter was leaking and will not drain; Medline clinician tried troubleshooting with staff.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50377200 ↗InjuryApr 8, 2026Insufficient Device Problem Information
"FOLEY CATH NOTED TO BE PARTIALLY INFLATED, FOLEY BALLOON NOTED TO ONLY BE INFLATED WITH 7ML OF FLUID NOT 10 ML."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24818480 ↗MalfunctionMar 24, 2026Material Rupture
PER EMAIL; RUPTURED FOLEY CATHETER BALLOON INSIDE PATIENT, USED FOR CHEMOTHERAPY INSTILLATION (OFF-LABEL)
Patient problems: Burning Sensation
MAUDE report 24676482 ↗MalfunctionMar 23, 2026Leak/Splash; Material Rupture
ACCORDING TO THE CUSTOMER CONTACT, ONCE THE FOLEY CATHETER WAS INSERTED "THE BALLOON DID NOT HOLD WATER." THE CUSTOMER CONTACT STATED THAT AS A RESULT, THE FOLEY CATHETER HAD TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663712 ↗MalfunctionMar 16, 2026
PT FULLY DILATED, DR. [REDACTED] AT BEDSIDE FOR BEDSIDE SONO [SONOGRAM] WITH SVE [STERILE VAGINAL EXAMINATION]. UPON PROVIDER EXAM, PROVIDER STATES SHE COULD FEEL THE FOLEY BALLOON CATH AT THE EDGE OF PT URETHRA AND BEHIND BABY HEAD AND FOLEY CATH COMPLETELY DISLODGED AND CAUSE EXTENSIVE URETHRAL TRAUMA. RN AT BEDSIDE WITH DR. [REDACTED]. FOLEY CATH NOTED TO BE PARTIALLY INFLATED, FOLEY BALLON NOTED TO ONLY BE INFLATED WITH 7ML OF FLUID NOT 10 ML (NO LEAKING NOTED ON FOLEY CATH UPON EXAMINATION). PRESSURE APPLY TO URETHRA BY DR. [REDACTED], DR. [REDACTED] AND DR. [REDACTED] AT BEDSIDE FOR ASSESSMENT AND PT STRAIGHT CATH BEFORE PUSHING AND UROLOGY TEAM INVOLVED AFTER PT DELIVERED. PT PUSHED FOR 10 MIN AND ONLY HAD A 1ST DEGREE LACERATION. UNKNOWN IF PRODUCT WAS DEFECTIVE. FOLEY CATHETER PLACED WITH 10ML IN THE BALLOON. FOLEY CATHETER WAS EXPELLED THROUGH THE URETHRA WITH BALLOON INFLATED. VOLUME OF BALLOON WAS CHECKED AFTER EXPULSION AND HAD 7ML IN BALLOON. PRIOR TO THE EXPULSION OF THE FOLEY CATHETER, THE PATIENT WAS IN LABOR AND HER CERVIX FULLY DILATED TO 10CM. OTHER INFO FROM CATHETER PACKAGING: URO175716, (B)(4), EXP:2027-04-30.
Patient problems: Laceration(s); Perineal injury
MAUDE report 24604448 ↗MalfunctionFeb 25, 2026Material Rupture
ACCORDING TO THE CUSTOMER CONTACT, "BALLOON POPPED WHEN THEY FILLED".
Patient problems: Insufficient Information
MAUDE report 24444642 ↗MalfunctionJan 12, 2026Material Rupture; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE MD NOTICED A DIFFERENCE AS HE INFLATED THE BALLOON ON THE CATHETER. HE PULLED ON THE CATHETER AND THE FOLEY CAME OUT. THE BALLOON WAS NOTED TO HAVE RUPTURED. A NEW FOLEY WAS INSERTED. THERE WERE NO REPORTS OF SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24037132 ↗MalfunctionNov 19, 2025Material Integrity Problem; Material Integrity Problem
MalfunctionJun 5, 2025Material Integrity Problem; Material Integrity Problem
InjuryApr 28, 2025Material Integrity Problem; Material Integrity Problem
MalfunctionDec 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY (B)(6) 2024 "REGISTERED NURSE INSERTED FOLEY CATHETER AND WHEN REGISTERED NURSE WENT TO INFLATE BALLOON OF THE FOLEY CATHETER NOTICED SOMETHING FLOATING IN THE SALINE SYRINGE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20893906 ↗MalfunctionOct 31, 2024
FOLEY WAS INSERTED, INFLATED BALLOON WITH ABOUT 1.5ML WHEN IT STOPPED. UNABLE TO INSERT OR WITHDRAW ANY FLUID FROM THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20576819 ↗InjuryApr 29, 2024Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE FOLEY WAS PLACED PRIOR TO A SURGICAL PROCEDURE BUT, THE "NURSE'S DOCUMENTATION" STATED WHEN ATTEMPTING TO INFLATE THE BALLOON THE "SALINE FLUSH WOULD NOT PUSH THROUGH THE VALVE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19209784 ↗
Other Foley catheter kit (excludes HIV testing) devices
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- Medline Industries, Inc. DYKE1721Medline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
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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