Medline URO170716Recalls & reported problems
Medline Industries, Inc. · TOTAL TRAY, DB, 100% SILI FOLEY, 16FR 10 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medline total tray with a silicone Foley catheter is used to place and drain urine from the bladder. The 28 reports mostly describe the tray components breaking, tearing or leaking — cracked syringes, holes and tears in the tubing, and balloon inflation or deflation trouble that sometimes let the catheter come out or require a second placement. Reports mention 18 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10888277866911), received between Jan 8, 2019 and Sep 16, 2026 — classified as 18 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem6
- Fluid/Blood Leak5
- Break4
- Inflation Problem3
- Appropriate Device Problem Term/Code Not Available2
- Crack2
- Deflation Problem2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Insufficient Information6
- No Consequences Or Impact To Patient2
- Foreign Body In Patient1
- No Code Available1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Detachment of Device or Device Component; Damaged Thread
It was reported that, "It appears that the threads are stripped where the tubing attaches to the syringe. Today, the tubing actually snapped off, leaving the end attached to the syringe."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793126 ↗MalfunctionSep 16, 2026Break; Fitting Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791212 ↗MalfunctionSep 9, 2026Fluid/Blood Leak; Material Puncture/Hole
It was reported that "Foley balloon pinhole leak" and "when reinflating the balloon, it was noted there was a tiny hole in the balloon and it was therefore leaking."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692938 ↗MalfunctionSep 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674677 ↗MalfunctionJan 12, 2026Material Puncture/Hole; Material Integrity Problem
ACCORDING TO THE FACILITY, ON (B)(6) 2025, AFTER AN INDWELLING URINARY CATHETER WAS PLACED, RN NOTICED LEAKING OF URINE ON THE BED PAD, AND NOTICED A HOLE IN THE TUBING OF THE FOLEY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24040004 ↗MalfunctionOct 15, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE "10ML SYRINGE PRODUCT WITHIN THE PRODUCT IS CRACKED AND LEAKS UPON USE."
Patient problems: Insufficient Information
MAUDE report 23291122 ↗MalfunctionOct 15, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE "10ML SYRINGE PRODUCT WITHIN THE PRODUCT IS CRACKED AND LEAKS UPON USE."
Patient problems: Insufficient Information
MAUDE report 23290661 ↗InjuryJan 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE FACILITY ON 12/6, THE FOLEY WAS PLACED AT 0538AM AFTER EPIDURAL PLACEMENT. THE BALLON WAS FILLED AND YELLOW URINE RETURNED IN THE BAG. TWO HOURS LATER WHEN PATIENT WAS CHECKED, THE FOLEY CATHETER WAS LAYING IN THE BED.
Patient problems: Insufficient Information
MAUDE report 21079170 ↗InjuryOct 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, THE FOLEY "RIPPED DURING DISCONNECTION" REQUIRING AN ADDITIONAL FOLEY TO BE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20509590 ↗InjuryApr 16, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, "IN EACH CASE, THE FOLEY WAS BEING INSERTED PRIOR TO SURGERY WHILE THE PATIENT WAS UNDER ANESTHESIA. BECAUSE OF DIFFICULTIES INFLATING THE BALLOON, A SECOND KIT WAS OBTAINED AND FOLEY REINSERTED".
Patient problems: Insufficient Information
MAUDE report 19115403 ↗InjuryApr 16, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, "IN EACH CASE, THE FOLEY WAS BEING INSERTED PRIOR TO SURGERY WHILE THE PATIENT WAS UNDER ANESTHESIA. BECAUSE OF DIFFICULTIES INFLATING THE BALLOON, A SECOND KIT WAS OBTAINED AND FOLEY REINSERTED".
Patient problems: Insufficient Information
MAUDE report 19115080 ↗InjuryApr 16, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, "IN EACH CASE, THE FOLEY WAS BEING INSERTED PRIOR TO SURGERY WHILE THE PATIENT WAS UNDER ANESTHESIA. BECAUSE OF DIFFICULTIES INFLATING THE BALLOON, A SECOND KIT WAS OBTAINED AND FOLEY REINSERTED".
Patient problems: Insufficient Information
MAUDE report 19114968 ↗InjuryApr 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER ON 3/19, "THE FOLEY WAS INSERTED INTO THE FEMALE PATIENT AND THE RN USED THE ENCLOSED SYRINGE WITH 10ML STERILE WATER TO INFLATE THE BALLOON. THE SURGEON NEEDED TO PERFORM A CYSTOSCOPY, SO SHE DEFLATED THE BALLOON AND REMOVED THE CATHETER. DURING THE CYSTOSCOPE, THE SURGEON NOTICED A FOREIGN BODY FLOATING IN THE BLADDER.
Patient problems: Foreign Body In Patient
MAUDE report 19114752 ↗InjuryMar 21, 2024Deflation Problem; Deflation Problem
ACCORDING TO THE CUSTOMER, THE FOLEY BALLOON "DEFLATED" CAUSING THE "LOSS OF CHEMO" AND "CHEMO LEAKAGE ONTO PATIENT".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18955758 ↗MalfunctionFeb 26, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE TIPS OF SYRINGE COMPONENTS ARE BREAKING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18777179 ↗MalfunctionOct 9, 2023Fluid/Blood Leak; Fluid/Blood Leak
FOLEY CATHETER LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17899957 ↗InjuryJun 27, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE CUSTOMER, THE PATIENT HAD A FOLEY INSERTED ON (B)(6) 2023 AND "3 HOURS LATER" THE BALLOON HAD "POPPED" CAUSING "BLOOD WHERE THE BALLOON WOULD HAVE BEEN".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17208637 ↗InjuryJun 27, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE CUSTOMER, THE PATIENT HAD A FOLEY INSERTED ON (B)(6) 2023 AND WOKE UP WITH PAIN AND THE FOLEY OUT ON (B)(6) 2023.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17208524 ↗InjuryJun 27, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE CUSTOMER, THE PATIENT HAD A FOLEY INSERTED ON (B)(6) 2023 AND THERE WAS "BALLOON DISRUPTION" CAUSING THE FOLEY TO COME OUT "HOURS AFTER" LEAVING THE UROLOGIST.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17208357 ↗InjuryMay 23, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY THE FOLEY CATHETER BALLOON BROKE INSIDE THE PATIENT. PER THE FACILITY THE CATHETER WAS INSERTED IN THE ER ON 05/01, AND THE BALLOON BROKE ON 05/06.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16985001 ↗MalfunctionMar 8, 2023Material Integrity Problem; Material Integrity Problem
CATHETER FELL OUT REQUIRING REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16502320 ↗InjuryFeb 23, 2023Break; Break
ACCORDING TO THE CUSTOMER, ON (B)(6) 2023, AFTER A FOLEY WAS INSERTED FOR "URINARY RETENTION," THE BALLOON WAS BEING INFLATED WHEN "THE TIP OF THE SYRINGE BROKE OFF IN THE PORT PRIOR TO THE RN INSTILLING THE NS TO INFLATE THE BALLOON."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16433430 ↗InjurySep 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON (B)(6) 2022. DURING THE INSERTION OF A FOLEY CATHETER, AFTER CONFIRMING PLACEMENT, THE FOLEY CATHETER SLIPPED OUT AND REQUIRED AN ADDITIONAL CATHETER PLACEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15405978 ↗InjuryJul 19, 2022Detachment of Device or Device Component
ACCORDING TO THE FACILITY A FOLEY CATHETER WAS PLACED ON 6/18 FOR URINARY RETENTION. PER THE FACILITY THE PATIENT FELT A 'POP' AND THE FOLEY CATHETER CAME OUT, REQUIRING A REPLACEMENT CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15059270 ↗InjuryJul 19, 2022Device Dislodged or Dislocated
ACCORDING TO THE FACILITY A FOLEY CATHETER WAS PLACED ON (B)(6) FOR URINARY RETENTION. PER THE FACILITY THE FOLLOWING DAY THE PATIENT FELT A 'POP' AND THE FOLEY CATHETER CAME OUT, REQUIRING A REPLACEMENT CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15058712 ↗
Other Catheter care tray devices
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- Centurion Medical Products Corp CVI680CMedline Industries, Inc. · Catheter care tray2 recalls0 reports
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- 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
- Centurion Medical Products Corp IVS3635BMedline 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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