ENDOPATH XCEL D12XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705036001584), received between Mar 2, 2020 and Jun 3, 2025 — classified as 6 malfunctions.

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

• MalfunctionJun 3, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND DURING PORTAL PUNCTURE, THE 12MM ETHICON TROCAR DISASSEMBLED, MAKING IT IMPOSSIBLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131164 ↗
• MalfunctionOct 8, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN POSITIONING THE TROCAR ON THE PATIENT WHEN REMOVING THE MANDREL, THE RUBBER FELL FROM THE TOP AND NO LONGER ENGAGED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396474 ↗
• MalfunctionMay 23, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TROCAR'S RUBBER VALVE CAME OFF WHILE THE SCREEN WAS BEING PASSED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19385958 ↗
• MalfunctionOct 6, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, MINOR DAMAGE TO THE PACKAGING WAS NOTED INDICATING CONTAMINATION OF THE PRODUCT. THERE WAS NO PATIENT CONSEQUENCE AS PRODUCT NOT USED ON PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10639886 ↗
• MalfunctionOct 6, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, MINOR DAMAGE TO THE PACKAGING WAS NOTED INDICATING CONTAMINATION OF THE PRODUCT. THERE WAS NO PATIENT CONSEQUENCE AS PRODUCT NOT USED ON PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10639875 ↗
• MalfunctionMar 2, 2020Retraction Problem

  IT WAS REPORTED THAT DURING A PROSTATECTOMY PROCEDURE, THE INSTRUCTOR NOTICED THAT THE TROCAR BLADE DID NOT RETRACT AS USUAL. IT WAS LOCKED AND THE SURGEON DECIDED TO CHANGE THE PRODUCT AND OPEN ANOTHER TROCAR. THE MOMENT THE INSTRUMENTATION ENCASED THE TROCAR IN THE CANNULA, THE BLADE ADVANCED AND WAS UNABLE TO DISARM IT. AT THAT MOMENT, IT WAS REQUESTED THE EXCHANGE OF THE MATERIAL, AVOIDING DAMAGE TO THE PATIENT. THE DEVICE HAD NOT BEEN INSERTED INTO THE PATIENT. THERE WAS NO DAMAGE TO THE PATIENT OR PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9775405 ↗