eXcelon M00564120Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729748243), received between May 25, 2017 and Apr 8, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Bent” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXCELON TBNA NEEDLE WAS USED IN THE LUNGS DURING A PULMO PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS REMOVED FROM THE PATIENT AFTER A SECOND PUNCTURE. WHEN THE NEEDLE WAS EXTENDED TO RELEASE THE SECOND SAMPLE, THE NEEDLE FELL OUT OF THE SHEATH. ANOTHER EXCELON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21796665 ↗
• InjuryOct 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON NEEDLE WAS USED IN THE BRONCHI DURING A TRANSBRONCHIAL ASPIRATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PIECE OF THE NEEDLE DETACHED INSIDE THE PATIENT AND REMAINED IN THE BRONCHIAL WALL. THE DETACHED PIECE WAS RETRIEVED USING A LUNG BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXCELON NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10718717 ↗
• MalfunctionFeb 2, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELONTRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN AN UNKNOWN ANATOMY AREA ON AN UNKNOWN DATE. THE NAME OF THE PROCEDURE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THE NEEDLE WAS PUSHED OUT THE SIDE OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7239202 ↗
• MalfunctionSep 15, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON¿ WAS USED IN THE LUNGS DURING A TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE NEEDLE WAS UNABLE TO ADVANCE. 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 WAS BENT, THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6868402 ↗
• MalfunctionMay 25, 2017Bent; Bent

  NOTE: THIS REPORT PERTAINS TO THE ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2017-01599 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TBNA NEEDLE WAS USED DURING AN ASPIRATION PUNCTURE PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE SYRINGE LUER LEAKED. THE PROCEDURE WAS NOT COMPLETED BECAUSE ANOTHER EXCELON TBNA NEEDLE WAS NOT AVAILABLE. 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. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; NEEDLE BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591706 ↗
• MalfunctionMay 25, 2017Bent; Bent

  THIS REPORT PERTAINS TO THE TWO OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2017-01591 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TBNA NEEDLE WAS USED DURING AN ASPIRATION PUNCTURE PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE SYRINGE LUER LEAKED. THE PROCEDURE WAS NOT COMPLETED BECAUSE ANOTHER EXCELON TBNA NEEDLE WAS NOT AVAILABLE. 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. 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 Consequences Or Impact To Patient

  MAUDE report 6591605 ↗