Medline DYND11554Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,100% SILICONE,10FR 3ML,LF · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884389034422), received between Apr 8, 2020 and Sep 4, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2044-2020 · Root cause: Manufacturing material removal · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Failure to Deflate1
- Inflation Problem1
- Material Integrity Problem1
- Unintended Deflation1
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Break; Unintended Deflation
Patient problems: Insufficient Information
MAUDE report 50613222 ↗MalfunctionMay 20, 2026Failure to Deflate
CUSTOMER STATES BALLOON DID NOT PASSIVELY DEFLATE.
Patient problems: Insufficient Information
MAUDE report 25237542 ↗InjuryAug 3, 2023Material Integrity Problem; Material Integrity Problem
PER THE FACILITY THE FOLEY CATHETER BALLOON RUPTURED INSIDE THE PATIENT AND CAUSED PAIN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17450620 ↗MalfunctionApr 8, 2020Inflation Problem
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT PROPERLY INFLATE, WHICH REQUIRED REMOVAL AND RE-INSERTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9935298 ↗
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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