Medline DYND11553Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,100% SILICONE,8FR 3ML,LF · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10080196848836), received between Aug 12, 2020 and Sep 4, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (2 reports).
1 FDA recall record name this device's identifier.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 28, 2019Terminated
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Z-2043-2020 · Root cause: Manufacturing material removal · FDA record ↗
Most reported problems
Device problems
- Failure to Deflate2
- Appropriate Device Problem Term/Code Not Available1
- Material Rupture1
- Obstruction of Flow1
Patient problems
- Discomfort2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- Urinary Retention1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Failure to Deflate
It was reported that 3 out of 7 catheters would not deflate in the morning when removing.
Patient problems: Discomfort
MAUDE report 50619011 ↗MalfunctionSep 3, 2026Failure to Deflate
Patient problems: Discomfort
MAUDE report 50588579 ↗MalfunctionSep 2, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566652 ↗InjurySep 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY THE CATHETER WAS DISLODGED FROM THE PATIENT, 'AND THE BALLOON APPEARED TO HAVE BURST'. PER THE FACILITY AN ADDITIONAL CATHETER WAS PLACED AND NO SERIOUS INJURY OCCURRED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15411248 ↗MalfunctionAug 12, 2020Obstruction of Flow
IT WAS REPORTED THE FOLEY CATHETERS WERE CAUSING THE END USER "MORE PRESSURE THAN USUAL AND NOT DRAINING."
Patient problems: Urinary Retention
MAUDE report 10395831 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.