Medline DYND11592Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,100% SIL,COUDE,16FR 10ML · 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 10884389124017), received between Mar 26, 2019 and Apr 28, 2026 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (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
- Obstruction of Flow2
- Deflation Problem1
- Disconnection1
- Material Integrity Problem1
Patient problems
- Discomfort2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- No Consequences Or Impact To Patient1
- Urinary Retention1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Disconnection
CUSTOMER REPORTED, "THE CATHETER CONNECTION IS DISCONNECTING.".
Patient problems: Insufficient Information
MAUDE report 25016890 ↗InjuryOct 21, 2025Obstruction of Flow; Obstruction of Flow
ON (B)(6) 2025, A 77-YEAR-OLD MALE PATIENT REPORTED SIGNIFICANT DISCOMFORT DUE TO A CLOGGED CATHETER. THE PATIENT ATTEMPTED TO FLUSH THE CATHETER WITHOUT SUCCESS AND REQUESTED A NURSE VISIT FOR REPLACEMENT. FOLLOW-UP CARE INCLUDED SCHEDULING AN ADDITIONAL NURSING VISIT TO ASSESS THE PATIENT AND REPLACE THE CATHETER.
Patient problems: Discomfort
MAUDE report 23349198 ↗InjuryOct 21, 2025Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE FACILITY, THE CATHETER WAS CLOGGED AND NOT FLOWING, CAUSING DISCOMFORT. THE CATHETER WAS REPLACED.
Patient problems: Discomfort; Urinary Retention
MAUDE report 23348137 ↗InjuryApr 19, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY ON (B)(6) 2023 "THE PATIENT GOT UP TO WALK AND THE FOLEY CATHETER FELL OUT AND THE BALLOON WAS COMPLETELY EMPTY AFTER 10CCS OF SALINE WERE USED TO INFLATE".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16769235 ↗MalfunctionMar 26, 2019Deflation Problem
IT WAS REPORTED THAT THE COUDE CATHETER'S BALLOON WOULD NOT DEFLATE DURING REMOVAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8451524 ↗
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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