Medline DYND11533Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,100%SILICONE,18FR,30ML,LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884389034552), received between Jun 22, 2020 and Feb 24, 2026 — classified as 3 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel2
- Material Integrity Problem2
- Material Rupture2
- Appropriate Device Problem Term/Code Not Available1
- Fluid/Blood Leak1
Patient problems
- Insufficient Information3
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Material Rupture
ACCORDING TO THE FACILITY, IT WAS REPORTED THAT A FOLEY CATHETER RUPTURED DURING INSERTION FOR CERVICAL RIPENING WHEN INFLATED WITH 12 ML OF STERILE WATER. THERE WAS NO FURTHER INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24427501 ↗InjuryMay 19, 2025Material Rupture; Material Rupture
FOLEY BALLOON RUPTURING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045705 ↗MalfunctionApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE FACILITY ON (B)(6) 2025 "THE PATIENT COMPLAINED OF BLADDER PAIN AND SAID THAT SHE FELT LIKE SHE HAD USED THE BATHROOM ON HERSELF, WHEN THE NURSE ASSESSED HER FOLEY, IT WAS HANGING OUT OF THE PATIENT WITH THE BALLOON DEFLATED".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21857887 ↗InjuryJan 6, 2025Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY, THE L&D DEPARTMENT HAD A MEDLINE BALLOON CATH MALFUNCTION INSIDE A PATIENT. THE FACILITY STATED THE PATIENT SAID SHE HEARD A POP AND THOUGHT HER WATER BROKE.
Patient problems: Insufficient Information
MAUDE report 21080141 ↗InjuryDec 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORT ON 11/02/2024 "THE BLUE TIP OF THE CATHETER BROKE OFF AND WAS LEFT IN THE PATIENT".
Patient problems: Foreign Body In Patient
MAUDE report 20854185 ↗MalfunctionFeb 7, 2024Material Integrity Problem; Material Integrity Problem
"THE BALLOON POPPED WHILE IN THE PATIENT".
Patient problems: Insufficient Information
MAUDE report 18663811 ↗MalfunctionJun 22, 2020Burst Container or Vessel
IT WAS REPORTED THE FOLEY CATHETER BALLOON BURST AND HAD TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10181372 ↗MalfunctionJun 22, 2020Burst Container or Vessel
IT WAS REPORTED THE FOLEY CATHETER BALLOON BURST AND HAD TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10180774 ↗
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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