EchoTip G24062Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002240629), received between Nov 14, 2017 and Dec 4, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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.

• MalfunctionDec 4, 2018Break; Break

  THE DEVICE WAS EVALUATED AND WHEN DISMANTLING THE HANDLE THE NEEDLE BROKE. CONSERVATIVE REPORT BASED ON THE US PRECEDENCE FOR BROKEN NEEDLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8128220 ↗
• MalfunctionMar 20, 2018Break; Break

  WHEN SETTING THE ADJUSTER ON MAXIMAL EXTENDING POSITION, SHEATH OF THE NEEDLE WAS STILL INSIDE OF THE WORKING CHANNEL (ABOUT 1,5 CM). UPON THE DEVICE EVALUATION IS WAS NOTED THAT THE NEEDLE WAS BROKEN IN THE HANDLE AND THE NEEDLE WAS ALSO CRUMPLED IN THE HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7353076 ↗
• MalfunctionNov 14, 2017Bent; Bent

  THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE CONCLUSIONS OF THE INVESTIGATION. NO BLEEDING DURING THE PROCEDURE. PROCEDURE STARTED WITH EBUS PROCORE 25G (NEEDLE TEST, SHE HAS NEVER USED 25G BEFORE) FOR FIRST FOUR PASSES. 2 PASSES FOR RIGHT HILAR, 2 PASSES FOR 4L : NEEDLE WEAKNESS THEN BREAKAGE DURING 4TH PASS THEN REMOVAL OF ALL TOGETHER(SEE FIRST COMPLAINT REPORT FOR DETAILS). THEN, A NEW NEEDLE, 25G ULTRA IS USED TO PROCEED PASSES FOR 4L. DOCTOR KNOWS NEEDLE IS MORE THIN, "FRAGILE" THAN 22GA, SHE IS CAREFUL WITH THE DEVICE. AT THE SECOND PASS, NEEDLE IS BENDED. PROCEDURE STOPPED. REMOVAL OF THE NEEDLE IN THE SHEATH. REMOVAL OF THE NEEDLE/SHEATH FROM ECHO ENDO. NO PROBLEM. A NEW AND LAST NEEDLE WAS NEEDED AND HAS BEEN USED : 22G ULTRA (THEY USE IT NORMALLY). FOR 4L AND LEFT HILAR (CLOSE TO IDENTIFIED AREA WITH PET/CT SCAN). PROCEDURE HAS BEEN ENDED WITHOUT INCIDENT ANYMORE. NO PROBLEM WITH ECHO ENDO. NO PROBLEM WITH ULTRA 22G NEEDLE INSERTION THROUGH ECHOENDO CHANNEL, NO REMOVAL PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7028075 ↗