ENDOPATH XCEL CB11LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705036001324), received between Dec 19, 2017 and Jan 13, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Product Quality Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STABILITY SLEEVE CB11LT PACKAGING/EXPECTED 11MM DIAMETER SLEEVE BUT MISLABELED AS A 12MM WITH TEAL LETTERING. NO PATIENT HARM AND PACKAGING INTACT/STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058332 ↗
• MalfunctionNov 2, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OVARIAN CYST REMOVAL PROCEDURE, BEFORE CLOSING THE PATIENT, THE SURGEON FOUND SMALL RUBBER CIRCLE-SHAPED PIECES OF THE TROCAR WERE DETACHED FROM THE PRODUCT AND WERE FOUND IN THE BODY. THE SURGEON REMOVED ALL PIECES FROM THE PATIENT. THE PATIENT IS FINE AND DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738358 ↗
• MalfunctionOct 20, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE HOSPITAL COMPLAINED THERE WAS NO CLEAR MARKING ON THE BOX TO INDICATE WHAT PRODUCTS WERE INSIDE, AND THE WRONG BOX WAS OPENED IN THEATRE. THIS PRODUCT WAS NOT USED IN CASE AND A NEW KIT WAS OPENED. THERE WAS NO HARM TO THE PATIENT AND APPROXIMATELY TWO MINUTES OF THEATRE TIME WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669486 ↗
• MalfunctionJul 28, 2021Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FRONT END OF THE PRODUCT WAS CURLED AND DEFORMED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236068 ↗
• MalfunctionDec 19, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION, AFTER INSERTING THE TROCAR INTO THE PATIENT AND INSERTING AN INSTRUMENT INTO THE TROCAR, THE DOCTOR NOTICED A TINY PIECE OF PLASTIC DISLODGED AS THE INSTRUMENT WAS INSERTED THROUGH THE TROCAR, INTO THE PATIENT. THE DOCTOR WAS ABLE TO RETRIEVE THE TINY PIECE OF PLASTIC FROM THE PATIENT. THE DOCTOR CONTINUED TO USE THE SAME TROCAR TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7128265 ↗