Medline DYND11573Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,3-WAY,18FR,30ML,100% SILI · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884389119532), received between Oct 15, 2024 and Feb 4, 2026 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2026Insufficient Device Problem Information
ACCORDING TO THE FACILITY ON (B)(6) 2025, THE PRODUCT WAS BEING USED BY AN EXPERIENCED NURSE PRACTITIONER FOR UROLOGY WHO STATES THAT THIS "FOLEY CATHETER COULD NOT BE PLACED IN A PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261666 ↗MalfunctionJan 7, 2026
MEDLINE 16 FR SILICONE FOLEY CATHETER COULD NOT BE PLACED IN A PATIENT. HAD TO USE ALTERNATIVE CATHETER. UNSURE IF THIS IS A PROBLEM WITH THE CATHETER ITSELF, BUT THE CATHETER IS DEFECTIVE AND IS NOT THE SAME AS AN ALL-SILICONE CATHETER. IT CAN CAUSE SEVERAL PATIENT ISSUES, INCLUDING OCCLUSION AND TRAUMA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23990280 ↗InjuryOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THERE WAS AN INCIDENT OF "LEAKING FROM THE FLUSH PORT." THE CUSTOMER REPORTED THAT THE CATHETER WAS "CHANGED DUE TO THE LEAKAGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393665 ↗InjuryOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THERE WAS AN INCIDENT OF "LEAKING FROM THE FLUSH PORT." THE CUSTOMER REPORTED THAT THE CATHETER WAS "CHANGED DUE TO THE LEAKAGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392901 ↗MalfunctionOct 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
URINE LEAKING OUT OF PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20516337 ↗MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
Other CATHETER, RETENTION TYPE, BALLOON devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON234 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MC. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® All-Silicone Foley Catheter 165812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON151 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON2 recalls46 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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