Medline Industries, Inc. URO175718Recalls & reported problems
Medline Industries, Inc. · 1LYRTR 18FR10ML 100%SILI SNAP · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489987430), received between Aug 25, 2025 and Sep 13, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (2 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
- Unintended Deflation2
- Inflation Problem1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2026Unintended Deflation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747015 ↗MalfunctionSep 10, 2026Inflation Problem
It was reported that "The balloon did not inflate, then wouldn't deflate and the balloon burst".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720861 ↗InjuryAug 27, 2025Unintended Deflation; Unintended Deflation
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THE CATHETER WAS PLACED AND "BALLOON FILLED WITH 10CC THEN THE CATHETER FELL OUT AND THE BALLON WAS NOT INFLATED" AND ANOTHER CATHETER WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903570 ↗MalfunctionAug 25, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FOLEY BALLOON RUPTURED DURING INFLATION. THE CATHETER WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22889997 ↗
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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