Medline DYND11776Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,SILI-ELAST,LTX,16FR,30ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10080196726585), received between Nov 12, 2019 and Jun 16, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Inflation Problem1
- Leak/Splash1
- Material Discolored1
Patient problems
- Insufficient Information2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Fluid/Blood Leak
IT WAS REPORTED THAT WHEN USING THE CATHETER, IT WOULD FILL TO 30ML, THE NEXT DAY THE RN'S ARE CALLED BACK OUT BY PATIENT STATING IT IS LEAKING, WHEN RN CHECKS, ONLY 6ML ARE REMAINING.
Patient problems: Insufficient Information
MAUDE report 25526859 ↗InjuryDec 10, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash
ACCORDING TO THE FACILITY, EVERY PATIENT THEY HAVE USED THIS ON HAS EXPERIENCED LEAKAGE AND THE CATHETER BALLOON HAS NOT BEEN STAYING INFLATED.
Patient problems: Insufficient Information
MAUDE report 20895279 ↗InjuryNov 12, 2019Material Discolored
IT WAS REPORTED THAT THE URINARY CATHETER WAS DISCOLORED AND THAT A PATIENT EXPERIENCED AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9310068 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page