ENDOPATH XCEL B5XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705036001249), received between Jul 19, 2019 and Sep 4, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND AFTER UNPACKING, IT WAS FOUND THAT THE PUNCTURE CORE WAS DEFORMED AND UNUSABLE. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963193 ↗
• MalfunctionOct 23, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN OPENING THE ITEM IN THE STERILE FIELD, NOTICED THAT THERE IS A DEFECT ON THE ITEM - TROCAR IS SLIGHTLY BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517666 ↗
• MalfunctionDec 20, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY, THERE WAS A CRACK WAS FOUND ON THE SLEEVE DURING THE PUNCTURE PROCESS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18368481 ↗
• InjurySep 27, 2022Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE; TITLE: THE EFFECT OF TRANSVESTIBULAR ENDOSCOPIC SURGERY ON THE COSMETIC OUTCOME AND LONG-TERM PROGNOSIS OF PATIENTS WITH UNILATERAL THYROID CARCINOMA. AUTHORS: HE LIANG, LI LEILEI, WU YALEI, QIU ZHENGLUN, ZHANG YANFANG. CITATION: CHINESE JOURNAL OF CLINICAL PRACTICAL MEDICINE, FEBRUARY 2021, VOL. 12, NO. 1, DOI: 10 3760/CMA J CN115570 ¯ 20200914 01423. THE OBJECTIVE OF THE STUDY WAS TO INVESTIGATE THE EFFECT OF TRANSORAL VESTIBULAR APPROACH ENDOSCOPY ON THE COSMETIC OUTCOME AND LONG-TERM PROGNOSIS OF PATIENTS WITH UNILATERAL PAPILLARY THYROID CARCINOMA. FROM NOVEMBER 2017 TO DECEMBER 2019, 80 PATIENTS WITH UNILATERAL PAPILLARY THYROID CARCINOMA WERE INCLUDED IN THE STUDY. THE PATIENTS WERE RANDOMLY DIVIDED INTO THE TOTAL AREOLA APPROACH GROUP AND THE TRANSORAL VESTIBULAR APPROACH GROUP, WITH 40 PATIENTS IN EACH GROUP. IN THE TOTAL AREOLA APPROACH GROUP, THERE WERE 8 MALES AND 32 FEMALES WITH A MEAN AGE OF 52.23 ± 5.32 YEARS (RANGE 35 TO 67 YEARS). IN THE TRANSORAL VESTIBULAR APPROACH GROUP, THERE WERE 9 MALES AND 31 FEMALES WITH A MEAN AGE OF 52.46 +/-5.58 YEARS (RANGE 33 TO 65 YEARS). IN THE TOTAL AREOLA APPROACH GROUP, THE 10 CM ENDOPATH XCEL

  Patient problems: Nerve Damage

  MAUDE report 15494992 ↗
• MalfunctionJul 19, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR HEAD WAS DETACHED FROM CANNULA. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809531 ↗