ENDOPATH XCEL H12LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705036002017), received between Feb 27, 2020 and Oct 22, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING AN UNKNOWN SURGERY, THE SUTURED OLIVE PLUG CAME OFF DURING USE (B)(6). ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23356325 ↗
• MalfunctionSep 11, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A HOLE IN THE PACKAGE BEFORE TOOK OUT THE CONTENTS, SO IT COULD NOT BE USED. 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 23025337 ↗
• MalfunctionOct 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEUDRE, TROCAR - PIECE BROKE OFF , UNCERTAIN WHEN IT CAME OFF. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506813 ↗
• MalfunctionOct 15, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TROCAR WAS BROKEN AND COULD NOT BE USED. THE TROCAR WAS REPLACED AND THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452302 ↗
• MalfunctionApr 23, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DUCKBILL VALVE WAS DAMAGED. 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 19164508 ↗
• MalfunctionFeb 12, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TROCAR SLEEVE BROKE. PROCEDURE DELAYED 5 MINUTES AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685712 ↗
• MalfunctionJan 31, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE TRYING ATTACH THE SUTURE TO THE TROCAR THE PIECE ON THE TROCAR BROKE OFF. THE BROKEN FRAGMENT WAS RECOVERED. THE TROCAR WAS REMOVED AND REPLACED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616917 ↗
• MalfunctionMay 16, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN TROCAR WAS PLACED, IT BROKE INTO PIECES. A NEW ONE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16941051 ↗
• MalfunctionApr 7, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WAS INSERTED INTO THE UMBILICAL HOLE AND WHEN ENTERING THE LENS THE MEMBRANE WAS BROKEN AND THE CO2 GAS ESCAPED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700177 ↗
• MalfunctionApr 6, 2022Manufacturing, Packaging or Shipping Problem; Material Integrity Problem; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, IT WAS FOUND THAT THE OUTER SEAL WAS MISSING WHEN THE PACKAGE WAS OPENED. 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 14028882 ↗
• InjuryOct 13, 2021Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, THE SURGEON FOUND BLACK PIECES OF THE UNIVERSAL TROCAR SEAL FELL INTO THE PATIENT. A LARGE PIECE WAS FOUND AND REMOVED BUT THERE WAS A LITTLE PIECE THAT WAS MISSING FROM THE LARGER PIECE THAT WAS NOT FOUND, THOUGH THEY USED A LAPAROSCOPE AND GRAPSERS TO SEARCH THE ABDOMINAL CAVITY FOR ADDITIONAL PIECES. IT WAS NOTED THAT SEVERAL ITEMS WERE USED DOWN THIS TROCAR PORT INCLUDING AN ATS45, GRASPER, SPECIMEN RETRIEVAL BAG, AND A RAYTEC SPONGE. THE APPENDIX WAS ALSO REMOVED THROUGH THIS PORT USING A SPECIMEN RETRIEVAL DEVICE. THE PATIENT HAS NOT EXPERIENCED ANY ISSUES SINCE PROCEDURE AND THERE IS NO PLAN FOR ANY REOPERATION TO LOCATE TINY SEAL PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12628748 ↗
• MalfunctionDec 10, 2020Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WAS CRACKED WHILE INSERTING THE PORT. THERE WAS NO DELAY TO PROCEDURE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988941 ↗
• MalfunctionJun 10, 2020Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  HASSAN TROCAR: LOSING CO2, SEAL TORN, OPENED NEW DEVICE AND CONTINUED PROCEDURE WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10141072 ↗
• MalfunctionMay 28, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA PROCEDURE, EVERYTHING HAD GONE WELL IN THE SURGERY UNTIL THE DOCTOR TRIED TO INTRODUCE A GAUZE THROUGH THE TROCAR. IT WAS DISASSEMBLED AND THE TROCAR CLEANING MEMBRANES DETACHED AND FELL INTO THE PATIENT. THE TROCAR WAS DISARMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10099470 ↗
• MalfunctionApr 1, 2020Crack; Melted

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE DEVICE MELTED AND CRACKED DURING USE. THERE WAS A POSSIBILITY THAT THE DEVICE TOUCHED A HARMONIC DEVICE. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED 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 9910975 ↗
• MalfunctionFeb 27, 2020Detachment of Device or Device Component

  MIDDLE AGED FEMALE UNDERGOING PROCEDURE: EXAMINATION UNDER ANESTHESIA, OPERATIVE LAPAROSCOPY, LYSIS OF ADHESIONS, UNILATERAL SALPINGO-OOPHORECTOMY, HYSTERECTOMY AND CYSTOSCOPY. DURING PROCEDURE, A GRAY BUTTON/CAP POPPED OF THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9763455 ↗