E-Cath® II Tsui® 311285-40ERecalls & reported problems
Pajunk GmbH Medizintechnologie · E-Cath® II Tsui® SonoPlex® Stim cannula 21G with indwelling catheter 18G x 80mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048223121924), received between Feb 14, 2025 and Feb 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (1 report).
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
- Complete Blockage1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2025Complete Blockage; Complete Blockage
IRN# (B)(4) INCIDENT OCCURRED IN USA: SAYS THEY COULD NOT BOLUS THROUGH THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21401512 ↗MalfunctionFeb 14, 2025Nonstandard Device; Nonstandard Device
IRN# (B)(4). INCIDENT OCCURRED IN USA: WITH NEEDLE INSERTED, UPON INJECTING MEDICATION, THE "HUB" SPRUNG LEAK. THERE WAS A "FOUNTAIN" OF MEDICATION SQUIRTING FROM THE HUB WHILE UNDER PRESSURE. TRIED ANOTHER NEEDLE AND THE SAME EVENT OCCURED. TRIED A DIFFERENT PKG., DIFFERENT LOT#- ALL OK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21383088 ↗
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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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