MEDLINE DYND19122Recalls & reported problems
Medline Industries, Inc. · SET,IRRIGATION,CYSTO,Y-TYPE,90 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10080196993826), received between Jul 31, 2026 and Sep 29, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Disconnection” (3 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
- Disconnection3
- Connection Problem2
- Fluid/Blood Leak1
- Improper Flow or Infusion1
- Material Puncture/Hole1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Improper Flow or Infusion
It was reported that roller shutoff valve does not completely shutoff the flow of the irrigation solution.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934437 ↗MalfunctionSep 25, 2026Connection Problem
It was reported that "Disconnections - connection to foley catheter is too small."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896770 ↗MalfunctionSep 24, 2026Disconnection; Material Twisted/Bent
It was reported that "The single-end connection tube is too flexible and kinks and pops off."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884071 ↗MalfunctionSep 22, 2026Disconnection; Fluid/Blood Leak
It was reported that "They leak at the connection."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856545 ↗MalfunctionSep 17, 2026Material Puncture/Hole
It was reported that 4 of the tubes had holes in them. The holes were reported to be up before the fill chamber.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802626 ↗MalfunctionSep 13, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747697 ↗MalfunctionJul 31, 2026Connection Problem
Patient problems: Insufficient Information
MAUDE report 50105078 ↗
Other System, irrigation, urological devices
- MED-RX 10-4001Canadian Hospital Specialties Limited · System, Irrigation, Urological1 recall0 reports
- Arthromatic/Uromatic 2C4041Baxter International Inc. · System, irrigation, urological40 reports
- MEDLINE DYND19124Medline Industries, Inc. · System, irrigation, urological4 reports
- MEDLINE DYND19120Medline Industries, Inc. · System, irrigation, urological3 reports
- Irrigation Set 313003B. Braun Medical Inc. · System, irrigation, urological2 reports
- Medline DYND19140Medline Industries, Inc. · System, irrigation, urological1 report
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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