ENDOPATH XCEL B11LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705036001126), received between Sep 6, 2018 and Sep 28, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Manufacturing, Packaging or Shipping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918429 ↗
• MalfunctionDec 8, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DISTAL TIP OF THE TROCAR HAD A FLAW IN THE INTEGRITY OF THE PLASTIC. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744466 ↗
• MalfunctionAug 21, 2025Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE REACHED THE LOCATION WITH THE LOOSE PART INSIDE THE PACKAGING (BROKEN). THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22863010 ↗
• MalfunctionMay 1, 2025Crack; Crack

  IT WAS REPORTED THAT DURING TRANS ORAL ENDOSCOPIC HEMITHYROIDECTOMY VESTIBULAR APPROACH, TIP OF THE BLADELESS TROCAR DEVICE WAS FOUND TO BE CRACKED/FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942548 ↗
• MalfunctionMay 1, 2025Crack; Crack

  IT WAS REPORTED THAT DURING TRANS ORAL ENDOSCOPIC HEMITHYROIDECTOMY VESTIBULAR APPROACH, TIP OF THE BLADELESS TROCAR DEVICE WAS FOUND TO BE CRACKED/FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942508 ↗
• MalfunctionSep 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200794 ↗
• MalfunctionMay 14, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TROCAR BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314839 ↗
• MalfunctionAug 13, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCARS HOUSING WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538166 ↗
• MalfunctionFeb 22, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, WHEN THE TROCAR WAS PLACED, IT GOT SPLIT INTO DIFFERENT PARTS. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417888 ↗
• MalfunctionSep 28, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ITEM B11LT CAME WITH TROCAR 11MM AND SLEEVE 12MM, ITEM IS FULLY SEALED FROM MANUFACTURE. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15497873 ↗
• MalfunctionJan 7, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT UPON USING 11 MM TROCAR WITH 30 DEGREE 5 MM SCOPE, HE SAW SHARDING IN THE OBTURATOR. THIS DID NOT AFFECT THE PATIENT, DID NOT ENTER THE ABDOMINAL CAVITY, BUT HINDERED THE SURGEON¿S VIEW WHILE ENTERING THE PERITONEAL CAVITY. THERE WAS NO DELAY TO PROCEDURE AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192605 ↗
• MalfunctionSep 8, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AT THE CONCLUSION OF AN UNKNOWN PROCEDURE THEY NOTICED A PIECE OF THE BLACK TROCAR DIAPHRAGM IN THE PELVIC FLOOR. IT WAS RETRIEVED AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443778 ↗
• MalfunctionAug 20, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE ¿BROKE OFF¿ IN THE PATIENT. A BLACK HALF OF A CIRCLE ¿RUBBER¿ PIECE WAS FOUND AFTER A SCOPE WAS RE-INTRODUCED. THE PIECE WAS RETRIEVED WITH A GRASPER WITHOUT ANY ADDITIONAL ASSISTANCE. ANOTHER DEVICE WAS NOT NEEDED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350567 ↗
• MalfunctionMay 10, 2021Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CO2 GAS WAS LEAKING FROM THE TROCAR. A NURSE FOUND THAT THE RUBBER SEAL WAS LOOSENED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803720 ↗
• MalfunctionSep 30, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT PRIOR TO A LAPAROSCOPIC CHOLECYSTECTOMY, THEY OPENED UP DEVICE, AND THERE WAS A PIECE MISSING, THE FLAPPER DOOR. THEY OPENED UP ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT CONTACT (NO PATIENT CONSEQUENCE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10610938 ↗
• InjuryMar 31, 2020Crack; Material Separation; Crack; Material Separation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DISTAL END OF THE TROCAR SLEEVE BROKE IN THE PATIENT. THE DOCTOR WAS ABLE TO VISUALLY RETRIEVE ONE PIECE FROM THE ABDOMEN BUT COULDN'T FIND THE OTHER PIECE, DECIDING TO LEAVE THE OTHER PIECE IN THE PATIENT. THE PIECE REMAINING WAS INTRA-ABDOMINAL AND THE TROCAR WAS NOT A REPROCESSED TROCAR. THE DOCTOR WAS ABLE TO COMPLETE THE PROCEDURE USING THE EXISTING TROCAR. THE PROCEDURE AND POST-OP CARE OF PATIENT WAS NOT ALTERED IN ANY WAY DUE TO THE RETAINED TROCAR PIECE. THERE WERE NO OTHER PATIENT CONSEQUENCES REPORTED AND THE PATIENT IS OK.

  Patient problems: No Code Available

  MAUDE report 9905857 ↗
• MalfunctionMar 26, 2020Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PRODUCT SHOWED FACTORY DAMAGE AS THE TIP WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886421 ↗
• MalfunctionMar 17, 2020Melted; Physical Resistance/Sticking; Melted; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ESOPHAGUS PROCEDURE, AFTER SOME TIME, THE SURGEON NOTICED THAT THE DEVICE WAS DRAGGING WHEN IT WAS PULLED BACK THROUGH THE TROCAR. IT LOOKED AS THOUGH THERE WERE MELTED GROOVES IN TO THE TROCAR. THE PROCEDURE WAS COMPLETED WITH THIS SAME TROCAR. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844788 ↗
• MalfunctionMar 17, 2020Melted; Physical Resistance/Sticking; Melted; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ESOPHAGUS PROCEDURE, HALFWAY THROUGH, THE SURGEON NOTICED THAT THE DEVICE WAS DRAGGING WHEN IT WAS PULLED BACK THROUGH THE TROCAR. IT LOOKED AS THOUGH THERE WERE MELTED GROOVES IN TO THE TROCAR. A SECOND LIKE DEVICE WAS PULLED AND THE PROCEDURE WAS COMPLETED WITH THE SECOND TROCAR. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844737 ↗
• MalfunctionJan 11, 2019Break

  THE TIP OF THE TROCAR WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241789 ↗
• MalfunctionDec 17, 2018Tear, Rip or Hole in Device Packaging

  THE PACKAGE UNCOMPLETED (HAVE A INCISION ON BACK). THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171096 ↗
• MalfunctionOct 4, 2018Scratched Material

  IT WAS REPORTED THAT THE TROCAR OUTER HAD A SCRATCH (01.MM) .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7935691 ↗
• MalfunctionSep 6, 2018Inadequacy of Device Shape and/or Size

  MISSHAPEN TIP TO STABILITY SLEEVE. NOTED WHEN PASSING THE TELESCOPE THROUGH THE SLEEVE AFTER INSERTION INTO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852554 ↗