Medline DYND11532Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,100%SILICONE,16FR,30ML,LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10080196170982), received between Sep 29, 2022 and Sep 3, 2026 — classified as 9 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (6 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
- Material Rupture6
- Material Integrity Problem3
- Appropriate Device Problem Term/Code Not Available1
- Material Split, Cut or Torn1
- Obstruction of Flow1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information3
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Material Rupture; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595597 ↗MalfunctionMar 12, 2026Material Rupture
ACCORDING TO THE FACILITY, A 30 CC FOLEY CATHETER RUPTURED WHILE BEING USED FOR IOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583530 ↗InjuryOct 28, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 "SOON AFTER INSERTION OF THE FOLEY CATHETER - THE BALLOON RUPTURES AND FALLS OUT OF PLACE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404998 ↗InjuryOct 28, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 "SOON AFTER INSERTION OF THE FOLEY CATHETER - THE BALLOON RUPTURES AND FALLS OUT OF PLACE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404764 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 "A FOLEY CATHETER HAD DISLODGED FROM A RESIDENTS BODY." THE CUSTOMER REPORTED THAT THE "BALLOON OF THE CATHETER WAS POPPED AND BROKEN, LIKELY OCCURRING WHILE INSIDE OF THE RESIDENT."
Patient problems: Insufficient Information
MAUDE report 23288904 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, "A FOLEY CATHETER HAD DISLODGED FROM A RESIDENTS BODY." THE CUSTOMER REPORTED THAT THE "BALLOON OF THE CATHETER WAS POPPED AND BROKEN, LIKELY OCCURRING WHILE INSIDE OF THE RESIDENT.".
Patient problems: Insufficient Information
MAUDE report 23277914 ↗InjuryApr 9, 2024Material Integrity Problem; Material Integrity Problem
InjuryFeb 26, 2024Obstruction of Flow; Obstruction of Flow
CLOGGING OF CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18784207 ↗InjuryApr 19, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY "THE FOLEY CATHETER FELL OUT OF THE PATIENT AND UPON INSPECTION THEY DISCOVERED THE FOLEY BALLOON HAD RUPTURED".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16769937 ↗InjuryApr 19, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY "THE FOLEY CATHETER FELL OUT OF THE PATIENT AND UPON INSPECTION THEY DISCOVERED THE FOLEY BALLOON HAD RUPTURED". PER THE FACILITY "THE CATHETER WAS IN FOR 1-2 DAYS WHEN THE INCIDENT OCCURRED AND AN ADDITIONAL CATHETER HAD TO BE PLACED".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16768980 ↗InjurySep 29, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON (B)(6) 2022 A FOLEY CATHETER WAS BEING PLACED BY A RESIDENT FOR LABOR INDUCTION WHEN THE CATHETER BALLOON POPPED REQUIRING AN ADDITIONAL CATHETER TO BE PLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15506755 ↗
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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