eXcelon M00564100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729748229), received between Jul 18, 2017 and Sep 16, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024

  WENT TO APPLY SUCTION ON DEVICE AND IT DID NOT ENGAGE, UNABLE TO COLLECT SPECIMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223829 ↗
• MalfunctionMar 9, 2023Defective Device; Physical Resistance/Sticking

  THE NEEDLE MALFUNCTIONED AND COULD NOT BE ADVANCED CONSISTENTLY THROUGH THE SHEATH. THIS MADE IT DIFFICULT TO OBTAIN ADEQUATE SPECIMENS FOR DIAGNOSIS AND ALSO PUT THE PATIENT AT RISK OF INJURY

  Patient problems: Insufficient Information

  MAUDE report 16512001 ↗
• MalfunctionJun 28, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TBNA NEEDLE WAS OPENED ON (B)(6) 2021. DURING PREPARATION, A HAIR WAS SEEN IN THE NEEDLE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXCELON TBNA NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080150 ↗
• MalfunctionMar 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TBNA NEEDLE WAS USED IN THE TRACHEA DURING A TRANSBRONCHIAL NEEDLE ASPIRATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE NEEDLE CAME APART INSIDE THE SCOPE. THE NEEDLE TIP DETACHED AND WAS RECOVERED FROM INSIDE THE SCOPE BY THE DECONTAMINATION TEAM AFTER THE SCOPE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXCELON NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11571612 ↗
• MalfunctionJun 24, 2020Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PULMONARY BIOPSY NEEDLE WAS PLANNED TO BE USED IN THE RESPIRATORY TRACT DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE TIP OF THE NEEDLE WAS DETACHED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PULMONARY BIOPSY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **ADDITIONAL INFORMATION RECEIVED (B)(6), 2020** BASED ON THE PHOTOS RECEIVED, IT WAS NOTED THAT THE NEEDLE WAS NOT DETACHED BUT INSTEAD WAS DAMAGED AND CONSTRAINED WITHIN THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10192471 ↗
• InjuryOct 16, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TBNA NEEDLE WAS USED IN THE LUNG DURING A TRACHEA BIOPSY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL PORTION OF THE NEEDLE FRACTURED AND DETACHED INSIDE THE PATIENT. THE DETACHED NEEDLE WAS REMOVED FROM THE PATIENT USING FORCEPS. THIS PROCEDURE WAS NOT COMPLETED, BECAUSE ANOTHER EXCELON NEEDLE WAS NOT AVAILABLE FOR USE. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197874 ↗
• MalfunctionFeb 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TBNA NEEDLE WAS USED IN THE BRONCHIAL DURING A BRONCHOSCOPY BIOPSY SAMPLE PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, WHILE THE DOCTOR WAS PREPARING THE NEEDLE OUTSIDE OF THE PATIENT TO INSERT INTO THE SCOPE, A 2-3 CM PIECE OF THE SHEATH DETACHED AT THE DISTAL END OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8307558 ↗
• MalfunctionOct 31, 2017Material Perforation; Material Perforation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE TRACHEA DURING A BRONCHI TISSUE ACQUISITION PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE NEEDLE FAILED TO EXTEND AND WAS STUCK AT DISTAL STOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 STABLE THE INVESTIGATION FOUND THE NEEDLE HAD PUNCTURED THROUGH THE SHEATH, THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6990870 ↗
• MalfunctionSep 28, 2017Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE LUNGS DURING A TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE DEVICE ADVANCED THROUGH THE SCOPE, IT WAS NOTED THAT THE NEEDLE PUNCTURED THROUGH THE SHEATH AND WAS BENT. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6900525 ↗
• MalfunctionSep 14, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELONTRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN A PROCEDURE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE NEEDLE WAS BENT AT THE TIP AND IT WAS UNABLE TO BE RETRACTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6866349 ↗
• MalfunctionJul 18, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELONTRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE NEEDLE BENDS EASILY. ADDITIONAL INFORMATION RECEIVED ON AUGUST 01, 2017. DURING THE PROCEDURE IT WAS NOTED THAT THE NEEDLE EASILY BENDS. ADDITIONALLY, THE SYRINGE DIDN'T FIT CORRECTLY AND WOULDN'T FULLY SCREW ON CREATING A POOR VACUUM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WAS ¿NO DAMAGE TO THE PATIENT¿.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6722861 ↗