Echotip ClearCore G59742Recalls & reported problems
Cook Ireland Ltd · Echotip ClearCore EUS Biopsy Needle · Class 2
Data updated Oct 16, 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 00827002597426), received between Aug 11, 2025 and Nov 17, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Obtain Sample” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Obtain Sample1
- Material Twisted/Bent1
- Off-Label Use1
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.
MalfunctionNov 17, 2025Failure to Obtain Sample; Material Twisted/Bent; Failure to Obtain Sample; Material Twisted/Bent
AN INITIAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE DEVICE EVALUATION ON 10-OCT-2025. PER REP - (B)(6) 2025 - INITIALLY, THEY BIOPSIED THE LEFT LIVER LOBE AND WERE SUCCESSFUL IN OBTAINING A SAMPLE VIA A TRANS-GASTRIC APPROACH. THE NEEDLE WAS THEN REPOSITIONED TO SAMPLE RIGHT LIVER LOBE VIA A TRANS-DUODENAL APPROACH. HOWEVER, RESISTANCE WAS FELT WHEN EXTENDING THE NEEDLE OUT OF THE SCOPE. WHEN TRYING TO PUNCTURE TO OBTAIN THE SAMPLE, THE NEEDLE FAILED TO PUNCTURE AND PUSHED THE SAMPLE AWAY. TWO ATTEMPTS WERE TRIED AND UPON THE SECOND FAILURE, THE NEEDLE WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITIVE NEEDLE. 1. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? N/A, YES, NO. NO. 2. WAS PUNCTURE OF THE TARGETED SITE DIFFICULT? YES. 3. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? FUJI. 4. WAS THE SCOPE RECENTLY SERVICE/REPAIRED? UNKNOWN. 5. WAS THE DEVICE USED IN A TORTUOUS POSITION? SOMEWHAT. TRANSDUODENAL PUNCTURE ATTEMPTED. 6. WAS FORCE REQUIRED TO REMOVE THE DEVICE? N/A, YES, NO NO. 7. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TORETURN? (IF YES, PLEASE SPECIFY WHAT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23567952 ↗MalfunctionAug 11, 2025Off-Label Use; Off-Label Use
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 25-SEP-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769685 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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