Medline DYND160814TRecalls & reported problems
Medline Industries, Inc. · TRAY,ERASE CAUTI,TEMP SENS 14FR 10ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884389123102), received between Dec 18, 2025 and Sep 30, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (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
- Failure to Deflate2
- Material Rupture2
- Expulsion1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Expulsion
It was reported that "Nurse found Foley catheter out and was laying on floor. It appears that the Foley balloon was defective."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949908 ↗MalfunctionSep 9, 2026Failure to Deflate
It was reported that "Nurse attempted to deflate balloon and no saline came out. Nurse then squeezed tubing below syringe connected area and 8cc of saline came out.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693352 ↗MalfunctionSep 8, 2026Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658907 ↗InjuryDec 23, 2025Material Rupture; Material Rupture
ACCORDING TO THE FACILITY S FOLEY WAS PLACED AND THE BALLOON BURST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23880084 ↗InjuryDec 18, 2025Material Rupture; Material Rupture
ACCORDING TO THE CUSTOMER, THE FOLEY BALLOON "BURST" DURING INSERTION AND REQUIRED AN ADDITIONAL FOLEY TO BE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838451 ↗
Other Catheter care tray devices
- Centurion Medical Products Corp CVI680CMedline Industries, Inc. · Catheter care tray2 recalls0 reports
- Medline Industries, Inc. DYNJ81597Medline Industries, Inc. · Catheter care tray2 recalls0 reports
- Bardia® Foley Catheter Insertion Tray 802010C. R. Bard, Inc. · Catheter care tray54 reports
- Medline DYND10160Medline Industries, Inc. · Catheter care tray1 recall4 reports
- Medline DYNC1816Medline Industries, Inc. · Catheter care tray1 recall2 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page