Medline DYND11504Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,100%SILICONE,20FR,10ML,LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10080196845521), received between Oct 14, 2019 and Sep 7, 2026 — classified as 6 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Gas/Air 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
- Appropriate Device Problem Term/Code Not Available2
- Gas/Air Leak2
- Material Integrity Problem2
- Burst Container or Vessel1
- Deflation Problem1
- Material Perforation1
- Material Puncture/Hole1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Clinical Signs, Symptoms or Conditions3
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2026Deflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50657097 ↗InjuryMar 20, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE CUSTOMER, THE "BALLOON RUPTURED INSIDE OF THE PATIENT AND FELL OUT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18944228 ↗InjuryOct 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER ON (B)(6) 2023 THE FOLEY CATHETER BALLOON DEFLATED AND IT HAD TO BE REPLACED WITH ANOTHER FOLEY CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17895239 ↗InjuryOct 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER ON (B)(6) 2023 THE FOLEY CATHETER BALLOON DEFLATED AND IT HAD TO BE REPLACED WITH ANOTHER FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17895156 ↗InjuryMar 8, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE CUSTOMER ON (B)(6) 2023 "WHILE HER SON WAS BEING PLACED IN BED THE CATHETER CAME OUT" REQUIRING THE CUSTOMER TO REPLACE THE CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16505252 ↗InjuryMar 8, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE CUSTOMER ON (B)(6) 2023 "WHILE PUTTING HER SON ON THE COMMODE AND REMOVING HIS BRIEF, THE CATHETER CAME OUT" REQUIRING THE CUSTOMER TO REPLACE THE CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16504792 ↗InjuryFeb 9, 2023Material Puncture/Hole; Material Perforation; Material Puncture/Hole; Material Perforation
ACCORDING TO THE CUSTOMER ON 01/17/23 "THE FOLEY CATHETER CAME OUT AS THE BALLOON WAS NO LONGER INFLATED".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16334968 ↗MalfunctionNov 8, 2019Gas/Air Leak
IT WAS REPORTED THAT THE FOLEY CATHETER'S BALLOON SPONTANEOUSLY DEFLATED AND END-USER REQUIRED A NEW FOLEY CATHETER INSERTED.
Patient problems: No Code Available
MAUDE report 9295454 ↗MalfunctionOct 14, 2019Gas/Air Leak
IT WAS REPORTED THAT THE URINARY CATHETER BALLOON DEFLATED WHILE INSERTED INTO A SUPRAPUBIC SITE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9185967 ↗
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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