eXcelon M00564110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729748236), received between Sep 15, 2017 and Feb 13, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Bent” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryFeb 13, 2023Retraction Problem; Detachment of Device or Device Component; Material Twisted/Bent; Retraction Problem; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON NEEDLE WAS USED IN THE BRONCHUS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEEDLE GOT STUCK IN THE EXTENDED POSITION. AS THE PHYSICIAN ATTEMPTED TO REMOVE THE SCOPE WITH THE NEEDLE, THE NEEDLE DETACHED FROM THE DEVICE AND NEEDED TO BE RETRIEVED. THE NEEDLE WAS OBSERVED KINKED WHEN RETRIEVED. AT THIS TIME, IT IS UNKNOWN HOW THE NEEDLE WAS RETRIEVED. REPORTEDLY, THE DEVICE CAUSED TRAUMA TO THE SURROUNDING TISSUE AND A HEMORRHAGE OCCURRED. THE PHYSICIAN ADMINISTERED ADRENALINE TO THE AFFECTED AREA AND THE PATIENT WAS BROUGHT TO THE CRITICAL CARE UNIT FOR OBSERVATION. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. AT THIS TIME, THE PATIENT HAS RECOVERED AND HAS NO FURTHER COMPLICATIONS.

  Patient problems: Hemoptysis; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 16368239 ↗
• MalfunctionSep 15, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELONTRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE MAIN CARINA DURING A TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE NEEDLE WAS STUCK ON DISTAL STOP. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THE INVESTIGATION FOUND THAT THE NEEDLE WAS BENT, THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6868393 ↗