Harrell 000140Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653405051091), received between Mar 6, 2024 and Apr 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT MW5152454 ON 25MAR24. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 000140, HARRELL 7MM BRONCH BRUSH (20/CS) DEVICE THAT WAS BEING USED DURING AN UNKNOWN PROCEDURE ON 27FEB24. THE REPORT STATED, ¿HEAD CAME OFF INSIDE PATIENTS LEFT LOWER LOBE, DOCTOR RETRIEVED IT USING ION CATH, PULMONARY FORCEPS AND THERAPEUTIC BRONCHOSCOPE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164023 ↗
• MalfunctionMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5151131) RECEIVED ON 21FEB24. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE 000140, HARRELL 7MM BRONCH BRUSH (20/CS). THE REPORT STATES THAT ON (B)(6) ¿DURING PROCEDURE DR. UTILIZED HARRELL UNSHEALTHED CYTOLOGY BRUSH (LOT # 202303164) TO ATTEMPT BRUSHING OF RIGHT LOWER LOBE OF LUNG. UPON WITHDRAWAL OF DISPOSABLE SHEATH, IT WAS NOTED THAT THE BRUSH HEAD WAS NOT ATTACHED. DR. USED FLUOROSCOPY TO LOCATE BRUSH AND REMOVED WITH BIOPSY FORCEPS. BRUSH HEAD APPEARED INTACT. ALL BRUSHES WITH THIS LOT NUMBER WERE REMOVED FROM ROOM AND STOCK AT THIS TIME.¿ THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847076 ↗