Medline DYND11218Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,COUDE,LATEX,18FR,10ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196726776), received between May 23, 2019 and Aug 4, 2025 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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
- Inflation Problem2
- Deflation Problem1
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
- Obstruction of Flow1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, THE FOLEY "BALLOONS ARE LOSING WATER".
Patient problems: Insufficient Information
MAUDE report 22709606 ↗MalfunctionJun 2, 2025Inflation Problem; Inflation Problem
"BALLOON IS LOOSING WATER INSIDE OF THE PATIENT".
Patient problems: Insufficient Information
MAUDE report 22122425 ↗InjuryApr 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
"THE BALLOON DEFLATED WHEN INSERTING IT AND IT CAME OUT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21927845 ↗InjuryOct 1, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE CUSTOMER, OVER THE "LAST FEW YEARS" THE FOLEY BALLOONS "LEAK" CAUSING THE FOLEYS TO NOT LAST "30 DAYS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20343680 ↗MalfunctionFeb 13, 2020Deflation Problem
IT WAS REPORTED THAT THE URINARY CATHETER BALLOON WAS UNABLE TO BE FULLY DEFLATED.
Patient problems: No Code Available
MAUDE report 9705982 ↗MalfunctionMay 23, 2019Obstruction of Flow
IT WAS REPORTED THAT FOLEY CATHETERS WERE CLOGGING WITH SEDIMENTS REQUIRING FREQUENT THAN USUAL FOLEY CATHETER CHANGES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8637900 ↗
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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