Medline DYND11536Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,100%SILICONE,24FR,30ML,LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196029532), received between Aug 20, 2024 and Sep 4, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak2
- Break1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Genital Bleeding1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Fluid/Blood Leak
It was reported that "It was noticed while inflating the balloon with saline the blue cap and clear plastic have started leaking at about 9-10 ml and then separates."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619520 ↗MalfunctionSep 3, 2026Fluid/Blood Leak
It was reported that "It was noticed while inflating the balloon with saline the blue cap and clear plastic have started leaking at about 9-10 ml and then separates."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591008 ↗InjurySep 23, 2024Break; Break
ACCORDING TO THE FACILITY "THE FOLEY CATH BALLOON HAS POPPED WHILE IN US RESULTING IN BLEEDING".
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20279483 ↗InjuryAug 20, 2024Material Integrity Problem; Material Integrity Problem
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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