ENDOPATH XCEL K5LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705036002291), received between Jun 19, 2019 and Jun 19, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILE INSERTING TROCAR FOR THE FIRST TIME, YELLOW SHIELD GOT SPLIT. SURGEON WAS NOT ABLE TO REMOVE TROCAR FROM SLEEVE. HAD TO USE CLAMP TO BEND BACK YELLOW SHIELD IN ORDER TO REMOVE IT. THERE WERE NO PATIENT CONSEQUENCES. IT IS UNKNOWN IF THE PROCEDURE WAS DELAYED AND HOW THE PROCEDURE WAS COMPLETED. LOT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711756 ↗