Medline DYND11503Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,100%SILICONE,18FR,10ML,LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10080196845460), received between Nov 8, 2019 and Sep 4, 2025 — classified as 5 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (3 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
- Material Integrity Problem3
- Material Rupture2
- Appropriate Device Problem Term/Code Not Available1
- Deflation Problem1
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Abdominal Pain1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, THE CATHETER "FELL OUT" WHILE THE END-USER WAS "WALKING AROUND" AND A NEW CATHETER WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22973258 ↗MalfunctionJul 23, 2025Material Rupture; Material Rupture
A FOLEY BALLOON RUPTURED AND REQUIRED THAT A NEW CATHETER BE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22576652 ↗InjuryMay 28, 2025Deflation Problem; Deflation Problem
ACCORDING TO THE FACILITY "THE INCIDENT OCCURRED POST-OPERATIVELY ON THE SAME DAY THE PATIENT UNDERWENT A PROSTATECTOMY. WHILE EXPERIENCING ABDOMINAL PRESSURE, THE PATIENT WAS SITTING ON THE EDGE OF THE BED AND SUBSEQUENTLY LAID BACK. AT THAT MOMENT, THE FOLEY CATHETER DISLODGED AND FELL OUT.
Patient problems: Abdominal Pain
MAUDE report 22095753 ↗InjuryMay 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY THE BALLOON DEFLATED WHILE IN PLACE IN A PATIENT REQUIRING THE FOLEY CATHETER TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19278378 ↗MalfunctionDec 5, 2023Material Integrity Problem; Material Integrity Problem
InjuryNov 8, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 THE CATHETER THAT WAS PLACED ON (B)(6) 2023 CAME OUT WITH THE "BALLOON DEFLATED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093055 ↗InjuryApr 19, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY ON (B)(6) 2023 THE CATHETER BALLOON BURST REQUIRING THE FACILITY TO PLACE AN ADDITIONAL CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16768668 ↗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 9295596 ↗
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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