ENDOPATH XCEL B5LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10705036001225), received between Feb 23, 2018 and Aug 10, 2026 — classified as 1 death, 4 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Crack” (45 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 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Manufacturing, Packaging or Shipping Problem

  It was reported that during an Unknown surgery, opened the packing noted the device was damaged. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194153 ↗
• MalfunctionApr 21, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE AN UNK PROCEDURE USED ON THE PATIENT, NOTED THE SEAL WAS OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942587 ↗
• MalfunctionApr 11, 2026Product Quality Problem

  IT WAS REPORTED THAT BEFORE AN UNK PROCEDURE, A FOREIGN MATERIAL WHICH APPEARS TO BE A HAIR WAS IDENTIFIED IN AN UNOPENED PACKAGE OF THE PRODUCT. ISSUE WAS IDENTIFIED PRIOR TO A PROCEDURE AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847298 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT ¿RELEASE TABS FROZEN¿. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839533 ↗
• MalfunctionJun 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192701 ↗
• MalfunctionMar 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE AN UNKNOWN SURGERY, IT WAS NOTED THE PACKAGE WAS UNSEALED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691035 ↗
• MalfunctionMar 11, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS NOTED THE DEVICE WAS BROKEN . 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 21574778 ↗
• MalfunctionDec 4, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TROCAR BROKE. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845289 ↗
• MalfunctionNov 20, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733969 ↗
• MalfunctionOct 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY, TROCAR SHAFT SNAPPED IN HALF. RETRIEVED THE OTHER HALF AND COMPLETED THE CASE WITH A NEW DEVICE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465712 ↗
• MalfunctionOct 8, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WAS BENT. THIS HAPPENED DURING INSERTION INTO SUB XIPHISTERNUM AREA, WHEN THE TROCAR CANNOT GO THROUGH. A METAL PORT TO TRACT THAT AREA WAS USED FIRST BEFORE TROCAR WAS BEING INSERTED, AND DIDN'T FACE ANY CHALLENGE. NEEDED TO USE MORE STRENGTH TO INSERT THE TROCAR. THERE IS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396406 ↗
• MalfunctionSep 11, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN . 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 20195651 ↗
• MalfunctionSep 11, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, NOTED THE DEVICE WAS BROKEN. 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 20193340 ↗
• MalfunctionSep 11, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN . 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 20193270 ↗
• MalfunctionSep 6, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE LEAKED FROM THE PNEUMONIA THROUGHOUT THE PROCEDURE AND WAS DISMANTLED UPON COMPLETION AND REMOVAL FROM THE PATIENT'S BODY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155780 ↗
• MalfunctionSep 6, 2024Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE LEAKED FROM THE PNEUMONIUM THROUGHOUT THE PROCEDURE AND WAS DISMANTLED UPON COMPLETION AND REMOVAL FROM THE PATIENT'S BODY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155779 ↗
• MalfunctionAug 15, 2024Crack; Crack

  IT WAS REPORTED THAT DURING SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN . 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 19994184 ↗
• MalfunctionAug 6, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN. CHANGED TO ANOTHER DEVICE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 19924262 ↗
• MalfunctionAug 6, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERT INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN. CHANGED TO ANOTHER DEVICE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 19923860 ↗
• MalfunctionJul 16, 2024Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN OPENING THE PACKAGE, IT WAS NOTICED THE TROCAR WAS BROKEN BETWEEN THE METALLIC PART AND THE PLASTIC PART. NO PATIENT CONSEQUENCES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19754708 ↗
• MalfunctionMay 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WAS PACKAGED INCORRECTLY THAT THE ONE INSIDE THE PACKAGE WAS THE INCORRECT SIZE. THIS WAS NOTICED AFTER THE PACKAGING WAS OPENED. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381510 ↗
• MalfunctionApr 18, 2024Crack; Mechanical Problem; Material Integrity Problem; Crack; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE TROCAR BROKE AROUND THE RIBBING. IT PARTIALLY CRACKED AROUND THE RING. THEY WERE ABLE TO COMPLETE THE WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134941 ↗
• InjuryApr 17, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE TROCAR BROKE OFF INSIDE THE PATIENT OR WITHIN THE PACKAGING. NOT ABLE TO RETRIEVE THE TIP INSIDE THE PATIENT BUT WILL IF DISCOVERED LATER ON OR IF PATIENT EXPERIENCES POST-OP ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 19127283 ↗
• MalfunctionFeb 13, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER INSERTING INTO THE TROCAR, NOTED THE DEVICE WAS BROKEN . 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 18699360 ↗
• MalfunctionFeb 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAWS OF EL5ML COULD NOT BE CLOSED WHEN REMOVING IT THROUGH B5LT. 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 18641550 ↗