E-Cath acc. Tsui 201185-40ERecalls & reported problems
Pajunk GmbH Medizintechnologie · E-Cath acc. Tsui SonoPlex Stim cannula 21G x 68mm indwelling catheter 18G x 51mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14048223025281), received between Sep 9, 2016 and Sep 9, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
- Manufacturing, Packaging or Shipping Problem1
- No Flow1
- Nonstandard Device1
- Product Quality Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2016Fluid/Blood Leak; Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem; No Flow; Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem; No Flow
(B)(4). SUMMARIZING TRANSLATION FROM INITIAL REPORTERS NARRATIVE: FLUID LEAKAGE AT THE TUBE-TO-CATHETER-CONNECTION
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 5938679 ↗
Other CATHETER, CONDUCTION, ANESTHETIC devices
- ARROW IPN925037Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC7 recalls0 reports
- ARROW IPN924999Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC3 recalls0 reports
- ARROW IPN924964Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls1 report
- ARROW IPN927743Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN925052Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN925020Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN922619Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN924975Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page