ENDOPATH XCEL CB5STRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705036001355), received between Apr 15, 2019 and Jul 7, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionJul 7, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE CONTENTS OF PACKAGING LABELLED AS CB5ST WAS THE WRONG LENGTH. THE PACKAGING CONTAINS A CB5LT. THE REST OF THAT LOT NUMBER ON SITE WAS CHECKED, AND CONTAINED THE CORRECT ITEM INSIDE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411215 ↗
• MalfunctionSep 18, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TIP PART WAS MELTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250985 ↗
• InjuryApr 11, 2023Crack; Use of Device Problem; Crack; Use of Device Problem

  IT WAS REPORTED THAT DURING AN OB-GYN PROCEDURE, THE FORCEPS HIT THE TROCAR WHEN TAKING OUT THE FORCEPS THROUGH THE TROCAR, AND THE TIP OF THE TROCAR BROKE. THERE IS A POSSIBILITY THAT THE BROKEN PART WAS LEFT INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16714826 ↗
• InjuryFeb 11, 2022Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY, A "RUBBERY THING" FELL INTO THE ABDOMINAL CAVITY. THERE IS A POSSIBILITY THAT IT WAS FROM A COMPETITIVE DEVICE. THE DEVICE WAS USED ON THE STOMACH. THE SURGEON COMMENTED THAT A FORCEPS OR AN ELECTRIC DEVICE CLAMPED THE DEVICE. THE PROCEDURE WAS NOT CONVERTED TO AN OPEN PROCEDURE WHEN THE FALLEN PART WAS RETRIEVED. IT IS UNKNOWN WHETHER ALL PIECES WERE PICKED UP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT. THE PATIENT¿S CONDITION IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13518301 ↗
• MalfunctionJul 10, 2019Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE TIP OF THE SLEEVE WAS DEFORMED THINLY, AND FORCEPS CAUGHT AT THE TROCAR DURING USE. THE SAME DEVICE WAS USED AS IS TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776733 ↗
• MalfunctionApr 15, 2019Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE UNOPENED PACKAGE OF THE TROCAR WAS DAMAGED WITH A SMALL HOLE BEFORE USING ON THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8514157 ↗