Medline DYND11500Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,100%SILICONE,12FR,10ML,LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10080196801220), received between Mar 14, 2023 and Jun 26, 2026 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Dislodged or Dislocated1
- Incomplete or Inadequate Connection1
- Material Rupture1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Discomfort1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE LUER LOCK ON THE FOLEY CATHETER TUBING DISCONNECTED FROM TUBING AFTER URINE SAMPLE WAS OBTAINED.
Patient problems: Insufficient Information
MAUDE report 25641893 ↗MalfunctionMay 18, 2026Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY, A RN WENT TO REMOVE A FOLEY POST OP, THE BALLOON WAS DEFLATED AND REMOVED MOST OF THE WAY BUT THEN FELT RESISTANCE AT THE VERY END AS IT WAS STUCK.
Patient problems: Discomfort; Pain
MAUDE report 25210454 ↗InjuryNov 14, 2025Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated
DURING PATIENT REPOSITIONING, A FOLEY CATHETER DISLODGED. INSPECTION REVEALED THE RETENTION BALLOON HAD BURST. CATHETER WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23560462 ↗InjuryFeb 26, 2024Obstruction of Flow; Obstruction of Flow
CLOGGING OF CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18777387 ↗InjuryMar 14, 2023Break; Break
ACCORDING TO THE CUSTOMER, A FOLEY "BROKE INSIDE OF THE PATIENT WHILE IN USE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16537674 ↗
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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