Medline DYND110516Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,TEMP SENS,16FR 10ML,LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884389122976), received between Aug 28, 2018 and Sep 3, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Fluid/Blood Leak2
- Inflation Problem1
- Leak/Splash1
- Material Integrity Problem1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595750 ↗MalfunctionSep 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589280 ↗MalfunctionFeb 23, 2026Inflation Problem; Material Integrity Problem
FOLEY CATHETER "SLIPPED OUT" DUE TO BALLOON NOT BEING INFLATED.
Patient problems: Insufficient Information
MAUDE report 24421447 ↗InjuryAug 27, 2025Material Rupture; Material Rupture
ACCORDING TO THE FACILITY, "BALLOON APPEARS TO HAVE RUPTURED; FOLEY WAS FOUND OUT OF PATIENT." PER THE FACILITY, A NEW FOLEY CATHETER HAD TO BE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22904572 ↗MalfunctionSep 30, 2021Break
IT WAS REPORTED, THE BALLOON BROKE ON A FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12556288 ↗MalfunctionSep 30, 2021Break
IT WAS REPORTED, THE BALLOON BROKE ON A FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12556117 ↗MalfunctionAug 28, 2018Leak/Splash
IT WAS REPORTED THAT THE BOTTOM OF THE FOLEY CATHETER DRAINAGE BAG WAS LEAKING AT THE SEAM. THE FOLEY CATHETER WAS REMOVED AND A NEW FOLEY CATHETER WAS REQUIRED TO BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7822160 ↗
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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