EchoTip AcuCore G59746Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002597464), received between Mar 12, 2024 and Mar 18, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Retraction Problem; Material Twisted/Bent; Retraction Problem; Material Twisted/Bent

  THE PROVIDE EXPLAINED THAT AFTER PASS 4 WITH THE NEEDLE THEY WERE UNABLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH AND WAS ALSO UNABLE TO ADVANCE THE STYLET ALL THE WAY BACK INTO THE NEEDLE. THE CASES WERE COMPLETED WITH A COMPETITOR DEVICE. THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON (B)(6) 2025. 2. IS AN ACKNOWLEDGMENT LETTER (FORMAL NOTIFICATION OF THE COMPLAINT BEING RECEIVED) REQUIRED? NO 3. IS ANY ACCOUNT ACTION NEEDED (CREDIT, NO CHARGE REPLACEMENT, NO ACTION, INVESTIGATION RESULTS, ETC.)? NO CHARGE REPLACEMENT. 4. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.) NO 5. CAN YOU PROVIDE ANY PATIENT INFORMATION (AGE, WEIGHT, GENDER, PREEXISTING CONDITIONS)? NO 6. WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? ENDOSCOPIC ULTRASOUND WITH FINE NEEDLE BIOPSY. 7. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS, ETC.) PANCREAS. 1. (IF LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G., 2R, 2L, 4R, AO, AR, 11RI, 11S, ETC.). 8. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. UNKNOWN. 9. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NO 10. WAS PUNCTURE OF THE TARGETED SITE DIFFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632645 ↗
• MalfunctionOct 23, 2024Break; Break

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 14-FEB-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513615 ↗
• MalfunctionMay 29, 2024Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  DESCRIPTION OF EVENT: AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN EBUS WITH FINE NEEDLE BIOPSY PROCEDURE OF THE GASTRIC HEPATIC LYMPH NODE IN WHICH THE ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE, G59746, WAS USED. THE ECHOTIP NEEDLE WOULD NOT PENETRATE THE LESION. DEVICE WAS REMOVED FROM THE PATIENT AND PROCEDURE COMPLETED WITH AN OLYMPUS VISISHOT NEEDLE. PATIENT/EVENT INFO - NOTES: 4.1 FOR ALL COMPLAINTS, ASK: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? NO BEND OR KINK WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO. PLEASE SPECIFY IF YES. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? N/A. IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? N/A. IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NO. WAS THE DEVICE USED IN A TORTUOUS POSITION? NO. WAS PUNCTURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19413307 ↗
• MalfunctionMay 22, 2024Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  DESCRIPTION OF EVENT: PER REP - 25APR2024 - THE DOCTOR FOUND IT DIFFICULT TO PUNCTURE THE LESION. THEY DID GET IT WORK WITH DIFFICULTY FOR TWO PASSES BUT USED A COMPETITIVE NEEDLE FOR A THIRD PASS. PATIENT/EVENT INFO - NOTES: 4.0 RPN PREFIX ECHO 4.1 FOR ALL COMPLAINTS, ASK: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO -NO IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? N/A, HANDLE END, PATIENT END -N/A WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO -NO PLEASE SPECIFY IF YES. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? N/A, YES, NO -N/A IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? N/A, YES, NO -N/A IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? N/A, YES, NO -NO WAS THE DEVICE USED IN A TORTUOUS POSITION? N/A, YES, NO -NO WAS PUNCTURE OF THE TARGET SITE DIFFICULT? N/A, YES, NO -YES PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370086 ↗
• MalfunctionMar 12, 2024Loss of or Failure to Bond; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Improper or Incorrect Procedure or Method

  AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT EMAIL "THE DISTAL END OF THE HANDLE BECAME DETACHED FROM THE NEEDLE. THE NEEDLE WAS REMOVED FROM THE SCOPE AND THE HANDLE WAS REATTACHED TO THE NEEDLE AND SPECIMEN WAS OBTAINED. THE PROCEDURE WAS COMPLETED USING A COMPETITIVE DEVICE." PATIENT/EVENT INFO - NOTES: 4.1 FOR ALL COMPLAINTS, ASK: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? N/A, HANDLE END, PATIENT END WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO ¿ PLEASE SPECIFY IF YES. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? N/A, YES, NO IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? N/A, YES, NO ¿ IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? N/A, YES, NO WAS THE DEVICE USED IN A TORTUOUS POSITION? N/A, YES, NO WAS PUNCTURE OF THE TARGET SITE DIFFICULT? N/A, YES, NO PLEASE DESCRIBE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886258 ↗