CONMED 130Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10653405052340), received between Apr 16, 2018 and Feb 20, 2025 — classified as 3 injuries, 1 malfunction.

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

• InjuryFeb 20, 2025Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER (B)(4) ON 4FEB2025. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST A 130, DISP MICROBIOLOGY BRUSH,Ø1 MM,1.8 MM WORKING DIA,110 CM L, DEVICE. THE DATE OF THE PROCEDURE WAS (B)(6) 2024. THE REPORTER REMAINED ANONYMOUS. THE REPORT STATES, ¿BRUSHING PERFORMED DURING BRONCHOSCOPY, WHILE THE PHYSICIAN WAS BRUSHING, THE BRUSH BROKE OFF INTO THE LUNG. THE PHYSICIAN ATTEMPTED TO REMOVE THE OBJECT, HOWEVER IT MOVED OUT OF VIEW. DURING BRUSH INSERTION INTO THE SCOPE, THERE WAS NO RESISTANCE OR KINKING. PHYSICIAN REQUESTED A STAT CHEST RADIOGRAPH, THE X-RAY COULD NOT VISUALIZE THE BRUSH.¿ THERE WAS NO REPORT OF HOSPITALIZATION FOR THE PATIENT DUE TO THE INCIDENT. THE REPORTER REMAINED ANONYMOUS; THEREFORE, CONMED IS UNABLE TO REQUEST FURTHER INFORMATION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF COMPONENT LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21420008 ↗
• MalfunctionSep 20, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE 130, DISP MICROBIOLOGY BRUSH,Ø1 MM,1.8 MM WORKING DIA,110 CM L WAS BEING USED ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿WHEN WE HAD THE BRUSH INTO THE SCOPE INTO THE AIRWAY I PUSHED THE BRUSH TIP OUT AND THIS SOFT BRISTLE LIKE OBJECT WAS PUSHED OUT INTO THE AIRWAY, UPON INSPECTION, IT WAS THE BRUSH TIP THAT CAME OFF THE BRUSH. NO HARM WAS CAUSED.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT NO FURTHER INFORMATION WAS AVAILABLE, HOWEVER, ALL PIECES WERE RETURNED, AND THE DEVICE WAS INTACT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268287 ↗
• InjuryAug 18, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 130, 1MM MICROBIOLOGY BRUSH 5/CS, WAS BEING USED DURING AN INTERNAL/EXTERNAL BILIARY DRAIN PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿TUBING BROKEN OFF IN PATIENT AND WAS NOT ABLE TO BE REMOVED.¿. THE REPORTER ALSO STATED THAT THE PATIENT HAD PROLONGED HOSPITALIZATION. FURTHER ASSESSMENT QUESTIONS WERE SENT, AND THE REPORTER GAVE FURTHER EXPLANATION OF THE PROCEDURE BY SAYING, ¿4 FRENCH DELIVERY CATHETER WAS SUBSEQUENTLY ADVANCED OVER THE WIRE TO THE LEVEL OF THE AMPULLA FOR ACQUISITION OF BRUSH BIOPSY. UNSUCCESSFUL BRUSH BIOPSY SAMPLES DUE TO ADVANCEMENT OF CONMED CATHETER BECAME KINKED AND COULD NOT BE REMOVED OVER THE WIRE. THE HUB OF THE CATHETER WAS CUT AND REMOVED. ATTEMPTS WERE MADE TO REMOVE CATHETER THROUGH A 6FR VASCULAR SHEATH WITHOUT SUCCESS.¿. THE PROCEDURE WAS COMPLETED AFTER A 30-MINUTE DELAY. THE PATIENT WAS REPORTED AS CURRENTLY BEING IN THE HOSPITAL. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO DEVICE COMPONENT BEING LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15247897 ↗
• InjuryApr 16, 2018Detachment Of Device Component; Detachment Of Device Component

  CONMED RECEIVED A MEDWATCH REPORT SUBMITTED BY THE USER FACILITY. IN THIS REPORT, THE USER FACILITY STATED THAT POST BRONCHOSCOPY PROCEDURE, THE 130 MICROBIOLOGY BRUSH'S TIP WAS NOTICED TO BE MISSING. ATTEMPTS WERE MADE TO SEARCH FOR THE DETACHED TIP ON THE PATIENT AND IN THE BRONCHIAL LAVAGE, BUT THE DEVICE'S TIP WAS NOT FOUND. UPON MULTIPLE ATTEMPTS TO GATHER INFORMATION, THE REPORTER STATED THAT NO ADDITIONAL INFORMATION REGARDING THE PATIENT STATUS OR PROCEDURE WILL BE MADE AVAILABLE. THE ONLY INFORMATION PROVIDED IS THE MEDWATCH, WHICH MAKES NO MENTION/REPORT OF ANY PROCEDURAL DELAYS OR PATIENT INJURY. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION, DUE TO WHICH, PART OF THE DEVICE DETACHED AND IT'S LOCATION IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 7434372 ↗