Medline DYND11520Recalls & reported problems
Medline Industries, Inc. · TRAY,FOLEY,100% SILICONE,18FR,10ML,LF · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10080196997060), received between Mar 22, 2021 and Sep 8, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel5
- Device Slipped1
- Fluid/Blood Leak1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Discomfort1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658901 ↗MalfunctionMar 20, 2023Burst Container or Vessel; Burst Container or Vessel
CATHETER FELL OUT, OR WAS LEAKING REQUIRING REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16573923 ↗MalfunctionMar 20, 2023Burst Container or Vessel; Burst Container or Vessel
CATHETER FELL OUT, OR WAS LEAKING REQUIRING REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16573866 ↗MalfunctionMar 20, 2023Burst Container or Vessel; Burst Container or Vessel
HOLD JS 3/21. BALLOON DEFLATED/RUPTURED REQUIRING REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16572640 ↗MalfunctionMar 20, 2023Burst Container or Vessel; Burst Container or Vessel
BALLOON DEFLATED/RUPTURED REQUIRING REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16572479 ↗InjuryDec 8, 2021Burst Container or Vessel; Device Slipped
IT WAS REPORTED THAT THE INDWELLING FOLEY CATHETER BALLOON BURST WHILE INSERTED IN THE PATIENT. THE CATHETER FELL OUT OF THE PATIENT AND WAS REPLACED WITH A NEW CATHETER.
Patient problems: Discomfort
MAUDE report 12964917 ↗MalfunctionMar 22, 2021Inflation Problem
IT WAS REPORTED THAT THE URINARY CATHETER BALLOON WOULD NOT INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11537099 ↗
Other CATHETER, IRRIGATION devices
- Navarre Opti-Drain NOD8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION901 reports
- Navarre NNU8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION736 reports
- BLAKE 2227Ethicon Inc. · CATHETER, IRRIGATION331 reports
- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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