Medline DYND160716Recalls & reported problems
Medline Industries, Inc. · TRAY,FOLEY,ERASE CAUTI,100%SILI,16FR10ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884389235133), received between Apr 24, 2018 and Sep 28, 2026 — classified as 10 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (7 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
- Inflation Problem7
- Fluid/Blood Leak3
- Material Rupture2
- Appropriate Device Problem Term/Code Not Available1
- Leak/Splash1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923802 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903590 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903561 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903515 ↗MalfunctionAug 18, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FOLEY BALLOON RUPTURED AND THE CATHETER FELL OUT OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22829154 ↗InjuryFeb 20, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 DURING INSERTION OF FOLEY CATHETER THE "BALLOON WOULD NOT INFLATE, REQUIRING AN ADDITIONAL CATHETER TO BE INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21426013 ↗InjuryFeb 20, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 DURING INSERTION OF FOLEY CATHETER THE "BALLOON WOULD NOT INFLATE, REQUIRING AN ADDITIONAL CATHETER TO BE INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21425780 ↗InjuryOct 21, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE FACILITY ON 9/23, "AFTER INSERTION, THE BALLOON WOULD NOT INFLATE. CATHETER WAS REPLACED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20494606 ↗InjuryAug 26, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE FACILITY ON 7/26/2024, "THE FOLEY BALLOON COULD NOT BE INFLATED. A NEW CATHETER WAS INSERTED. THERE WAS NO INJURY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20065525 ↗InjuryAug 12, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE FACILITY ON 7/15, "THERE WAS A FOLEY BALLOON PINHOLE LEAK AND THE FOLEY WAS REPLACED."
Patient problems: Insufficient Information
MAUDE report 19961246 ↗InjuryJul 23, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 AFTER INSERTING A FOLEY ON A MALE PATIENT THEY "WERE UNABLE TO BLOW UP THE BALLOON".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19810293 ↗InjuryJul 15, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 AFTER INSERTING A FOLEY THEY "WERE UNABLE TO BLOW UP THE BALLOON".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19746713 ↗InjuryJul 12, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 AFTER INSERTING A FOLEY THEY "WERE UNABLE TO BLOW UP THE BALLOON".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19731295 ↗InjuryJul 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON 06/05/2024 THE "CLINICIAN DESCRIBED AN INABILITY TO INFLATE THE BALLOON AFTER INSERTION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19721399 ↗InjuryApr 24, 2018Patient-Device Incompatibility
IT WAS REPORTED THAT THE END-USER EXPERIENCED IRRITATION AND A NEW FOLEY CATHETER WAS REQUIRED TO BE INSERTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7453917 ↗
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- SureStep Intermittent Catheter Tray INTAAIC. R. Bard, Inc. · Catheter care tray1 recall1 report
- Medline DYND10407Medline Industries, Inc. · Catheter care tray1 recall1 report
- MEDLINE URO4RR16CMedline Industries, Inc. · Catheter care tray1 recall0 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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