Echotip Insight G46560Recalls & reported problems
Cook Ireland Ltd · Echotip Insight Portosystemic Pressure Gradient Measurement System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002465602), received between Jun 29, 2023 and Jul 11, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Material Twisted/Bent1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
PER REP - 13JUN2024 - THE DEVICE WAS GIVING SOME ERRONEOUS READINGS FOR THE HEPATIC AND PORTAL PRESSURE. WHEN MOVING THE MANOMETER, THE NUMBERS WOULD MOVE AROUND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19719178 ↗MalfunctionJan 10, 2024
MALFUNCTION WHILE SETTING UP FOR PROCEDURE, UNABLE TO FLUSH HEPARIN THROUGH THE NEEDLE, UNABLE TO USE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18484251 ↗MalfunctionJun 29, 2023Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17225570 ↗
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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