Formula 0375628000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327061987), received between Jul 10, 2018 and Oct 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE OUTER TUBE DETACHED FROM THE DEVICE AFTER THE NURSE CLEANED THE DEVICE. THE DETACHED PART DIDN¿T FELL INTO PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352156 ↗
• MalfunctionMar 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BREAKING DURING THE PROCEDURE. ALL BROKEN PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684159 ↗
• MalfunctionOct 19, 2023Material Fragmentation; Material Integrity Problem; Material Fragmentation; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967778 ↗
• MalfunctionApr 26, 2022Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214954 ↗
• MalfunctionAug 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344452 ↗
• MalfunctionMar 10, 2021Packaging Problem; Contamination /Decontamination Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456210 ↗
• MalfunctionFeb 11, 2019Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8329181 ↗
• MalfunctionFeb 11, 2019Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8329127 ↗
• MalfunctionJul 10, 2018Break

  IT WAS REPORTED THAT THE TIP BROKE DURING A PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7675608 ↗