Medline Industries, Inc. DYND150116Recalls & reported problems
Medline Industries, Inc. · TRAY,FOLEY,LATX,16FR,10ML,W/SD · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10195327043339), received between Feb 22, 2024 and Sep 28, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Contamination” (1 report).
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
- Contamination1
- Deflation Problem1
- Failure to Deflate1
- Fluid/Blood Leak1
- Material Rupture1
- Obstruction of Flow1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Clinical Signs, Symptoms or Conditions2
- Urinary Incontinence1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Fluid/Blood Leak
It was reported that "Within 10 minutes the catheter slid out. After this, the RN tested the balloon and it slowly deflated over a couple minutes and appeared to be leaking from the balloon inflation port."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914953 ↗MalfunctionFeb 20, 2025Contamination; Contamination
IT WAS REPORTED THAT ON 01/23/2025 THERE WAS "MILDEW/MOLD FOUND INSIDE STERILE WATER SYRINGE INSIDE FOLEY KIT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21423328 ↗MalfunctionAug 6, 2024Deflation Problem; Failure to Deflate; Deflation Problem; Failure to Deflate
BALLOON WOULD NOT DEFLATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19923808 ↗InjuryApr 4, 2024Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, POST "BLADDER REPAIR" THE FOLEY WAS "LEAKING", THE NURSE FLUSHED THE CATHETER, AND LATER IT WAS NOTED THAT THE FOLEY BALLOON WAS "NOT INFLATED" DUE TO THE BALLOON BEING "RUPTURED".
Patient problems: Urinary Incontinence
MAUDE report 19041951 ↗InjuryFeb 22, 2024Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE CUSTOMER, ON 01/24/2024 AFTER THE FOLEY CATHETER WAS UTILIZED FOR ADMINISTRATION OF "CHEMOTHERAPY MEDICATIONS INTO THE BLADDER" THE "FLUID IN THE BALLOON WOULD NOT COME OUT WHEN A SYRINGE WAS ATTACHED PER STANDARD PRACTICE" FOR THE REMOVAL OF THE FOLEY CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18759031 ↗
Other Foley catheter kit (excludes HIV testing) devices
- Medline Industries, Inc. DYND150200SMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYKE1455BMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYNJ902831DMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYNJ66449Medline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYNJ36728CMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYKE1350DMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- Medline Industries, Inc. DYNJ22890MMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)2 recalls0 reports
- 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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