Cellebrity M00516000Recalls & reported problems
Boston Scientific Corporation · Endoscopic Cytology Brush · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729746232), received between Mar 3, 2025 and Mar 3, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO PULMONARY CYTOLOGY BRUSHES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PULMONARY CYTOLOGY BRUSH WAS TO BE USED DURING A PULMONARY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A CYTOLOGY BRUSH WAS OPERATED, AND IT WAS OBSERVED THAT THERE WAS NO BRUSH ATTACHED TO THE METAL TIP. ANOTHER BRUSH WAS OPENED FROM THE SAME LOT, WHICH ALSO DID NOT HAVE A BRUSH ATTACHED ON THE METAL TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER PULMONARY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21501803 ↗MalfunctionMar 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO PULMONARY CYTOLOGY BRUSHES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PULMONARY CYTOLOGY BRUSH WAS TO BE USED DURING A PULMONARY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A CYTOLOGY BRUSH WAS OPERATED, AND IT WAS OBSERVED THAT THERE WAS NO BRUSH ATTACHED TO THE METAL TIP. ANOTHER BRUSH WAS OPENED FROM THE SAME LOT, WHICH ALSO DID NOT HAVE A BRUSH ATTACHED ON THE METAL TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER PULMONARY CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21501801 ↗
Other BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) devices
- Cellebrity M00516150Boston Scientific Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)17 reports
- Cellebrity M00516010Boston Scientific Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)10 reports
- CONMED 130Conmed Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)4 reports
- Cellebrity M00516070Boston Scientific Corporation · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)3 reports
- superDimension SDTNB1500Covidien LP · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)2 reports
- superDimension SDTNB1000Covidien LP · BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)2 reports
- superDimension SDTNB1000Covidien LP · Brush, biopsy, bronchoscope (non-rigid)1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.