EchoTip G25492Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002254923), received between Nov 10, 2017 and Nov 16, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2017Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICAL USED A COOK ECHOTIP ULTRASOUND NEEDLE. DURING AN EUS WITH A FINE NEEDLE ASPIRATION (FNA) PROCEDURE, THE ECHOTIP ULTRASOUND NEEDLE WAS USED. WHILE PULLING THE DEVICE THROUGH THE SCOPE, THE HANDLE DETACHED FROM THE NEEDLE. NOTHING DETACHED INSIDE OF THE PATIENT. AN ADEQUATE SPECIMEN WAS OBTAINED SO NO FURTHER DEVICES WERE REQUIRED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 10/26/2017 AND IT WAS OBSERVED THE DISTAL END OF THE NEEDLE WAS SEVERELY BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7038462 ↗
• MalfunctionNov 10, 2017Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED COOK ECHOTIP ULTRASOUND NEEDLE. AS REPORTED TO CUSTOMER RELATIONS: "DURING AN EUS WITH AN FINE NEEDLE ASPIRATION (FNA) PROCEDURE, THE ECHOTIP ULTRASOUND NEEDLE WAS USED. WHILE PULLING THE DEVICE THROUGH THE ENDOSCOPE, THE HANDLE DETACHED FROM THE NEEDLE. NOTHING DETACHED INSIDE OF THE PATIENT. AN ADEQUATE SPECIMEN WAS OBTAINED, SO NO FURTHER DEVICES WERE REQUIRED." THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 10/18/2017 AND A SEVERE BEND IN THE DISTAL END OF THE NEEDLE WAS OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7017901 ↗