EchoTip ClearCore G60992Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002609921), received between Sep 18, 2025 and Jan 19, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Loss of or Failure to Bond

  A COMBINED INITIAL SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 23 DEC 2025. DESCRIPTION OF EVENT: THE CUSTOMER OPENED THE NEEDLE; THEY SAW THE LITTLE PLASTIC PART AT THE END OF THE NEEDLE WAS BROKEN (WHERE THE RECOIL STYLET GOES IN). THEY OPENED ANOTHER NEEDLE TO FINISH PROCEDURE. ANSWER TO ADDITIONAL QUESTIONS RECEIVED ON 04-NOV 25. 1. CAN PHOTOS OF THE DAMAGE BE PROVIDED? I SENT THE DEVICE IN TO COOK. 2. PLEASE DESCRIBE THE DAMAGE IN DETAIL: UPON OPENING THEY NOTICED THE PLASTIC PIECE AT THE BACK END OF THE NEEDLE WHERE THE RECOIL STYLET GOES WAS BROKEN 3. WAS THE DEVICE DAMAGE IDENTIFIED: A) PRIOR TO OPENING THE PACKAGE. -WHEN OPENING THE PACKAGE, THEY SAW IT WAS BROKEN. 4. WAS THE FUNCTIONALITY OF THE DEVICE TESTED PRIOR TO NOTICING THE DAMAGE? · IF YES, PLEASE PROVIDE ADDITIONAL DETAILS (INCLUDING OTHER DEVICES THAT MAY HAVE ENGAGED WITH THE COOK DEVICE). NO. 5. WERE ANY PREPARATORY STEPS PERFORMED TO THE DEVICE (PER INSTRUCTIONS FOR USE, IF APPLICABLE) PRIOR TO NOTICING THE DAMAGE? · IF SO, PLEASE DESCRIBE HOW THE DEVICE WAS PREPARED: NO 6. WAS THE DEVICE STORED ACCORDING TO THE STORAGE CONDITIONS ON THE LABEL (IF APPLICABLE)? · IF NO,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109462 ↗
• MalfunctionOct 28, 2025Retraction Problem; Material Twisted/Bent; Retraction Problem; Material Twisted/Bent

  THE NEEDLE TIP WOULD NOT GO FULLY BACK INTO THE SHEATH. THEY GOT ANOTHER DEVICE TO FINISH THE PROCEDURE. 1. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS, ETC.) (IF LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G., 2R, 2L, 4R, AO, AR, 11RI, 11S, ETC.) PANCREATIC HEAD 2. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? N/A, YES, NO YES 3. WAS PUNCTURE OF THE TARGETED SITE DIFFICULT? NO 4. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS 180 5. WAS THE SCOPE RECENTLY SERVICE/REPAIRED? NO 6. WAS THE DEVICE USED IN A TORTUOUS POSITION? YES 7. WAS FORCE REQUIRED TO REMOVE THE DEVICE? N/A, YES, NO 8. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TORETURN? (IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT(S) WERE OBSERVED AND WHERE ON THE DEVICE THIS WAS OBSERVED) NO 9. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? N/A, YES, NO10. IF ADDITIONAL INTERVENTION WAS PERFORMED, WAS IT DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A 11. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401906 ↗
• MalfunctionSep 18, 2025Accessory Incompatible; Off-Label Use; Accessory Incompatible; Off-Label Use

  WE USE THIS PRODUCT FOR COELIC PLEXUS BLOCK, WHEN WE ATTACHED THE 10ML SYRINGE THE NEEDLE CONNECTOR IS NOT FIX PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085723 ↗