ENDOPATH XCEL D12LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705036001577), received between Jan 8, 2018 and Sep 29, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Manufacturing, Packaging or Shipping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935647 ↗
• MalfunctionFeb 13, 2026Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE TROCAR PRESENTED A DEFECT IN THE MEMBRANE, CAUSING LOSS OF PNEUMOPERITONEUM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pneumothorax

  MAUDE report 24335461 ↗
• MalfunctionFeb 5, 2026Crack

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE BLADE IS NOT FIXED. SO REPLACE THE PRODUCT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271777 ↗
• MalfunctionJan 12, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE PLASTIC DEFECT OF THE TROCAR. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24044937 ↗
• MalfunctionDec 18, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THERE WAS A GAS LEAK THAT HAPPENED WHEN USING THE TROCAR, HCP USED A NEW TROCAR TO FINISH THE OPERATION. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838632 ↗
• MalfunctionDec 8, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE SPRING OF THE BLADE INSIDE THE TROCAR CANNOT EXTEND AND RETRACT PROPERLY. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745544 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ACCORDING TO THE REPORT, DURING USE THE TROCAR EXPLODED. IT WAS NECESSARY TO CONTINUE WITH THE RESET. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278615 ↗
• MalfunctionSep 17, 2025Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RETOSIGMOIDECTOMY WAS STARTED, THE TROCAR WAS USED, WHICH BEGAN TO LEAK THE GAS AND WHEN REMOVING IT FROM THE CAVITY, IT WAS OBSERVED THAT THE SAME CAME WITHOUT THE INTERNAL RUBBER THAT SEALS. ANOTHER ITEM WAS REQUESTED AND EVERYTHING OCCURRED IN THE USUAL WAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071973 ↗
• MalfunctionAug 11, 2025Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN OPENING THE STERILE PACKAGING OF THE PRODUCT, LARGE AMOUNT OF WHITE DUSTY MATERIAL (APPEARING TO BE COMING OUT OF THE PLASTIC SEAL OF THE PACKAGING) SPRAYED OUT POTENTIALLY CAUSING CONTAMINATION OF STERILE FIELD AND THE THEATRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770755 ↗
• MalfunctionAug 11, 2025Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN OPENING THE STERILE PACKAGING OF THE PRODUCT, LARGE AMOUNT OF WHITE DUSTY MATERIAL (APPEARING TO BE COMING OUT OF THE PLASTIC SEAL OF THE PACKAGING) SPRAYED OUT POTENTIALLY CAUSING CONTAMINATION OF STERILE FIELD AND THE THEATRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770739 ↗
• MalfunctionAug 11, 2025Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN OPENING THE STERILE PACKAGING OF THE PRODUCT, LARGE AMOUNT OF WHITE DUSTY MATERIAL (APPEARING TO BE COMING OUT OF THE PLASTIC SEAL OF THE PACKAGING) SPRAYED OUT POTENTIALLY CAUSING CONTAMINATION OF STERILE FIELD AND THE THEATRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770698 ↗
• MalfunctionMay 14, 2025Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A FAULTY SEAL, KEPT LEAKING THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017786 ↗
• MalfunctionDec 3, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE SHAFT HAS LOOSE RUBBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835665 ↗
• MalfunctionOct 30, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGICAL TROCAR HAD A DEFECT IN THE NOZZLE, WHICH WAS BROKEN AND LEAKING. REPLACED THE DEVICE WITH ANOTHER, ALLOWING THE PROCEDURE TO BE COMPLETED WITHOUT COMPLICATIONS OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570939 ↗
• MalfunctionOct 22, 2024Crack; Gas/Air Leak; Crack; Gas/Air Leak

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BROKEN DIAPHRAGM AND GAS ESCAPING. REPLACED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20508663 ↗
• MalfunctionOct 16, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A HOLE IN THE PRIMARY PACKAGING OF THE PRODUCT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462447 ↗
• MalfunctionJul 25, 2024Crack; Crack

  IT WAS REPORTED THAT DURING THE MIE PROCEDURE, DURING THE INSERTION OF THE TROCAR IN THE ABDOMINAL WALL THE TROCAR BROKE IN DIFFERENT LITTLE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827680 ↗
• MalfunctionApr 15, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A SMALL HOLE ON THE PACKAGE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104316 ↗
• MalfunctionApr 11, 2024Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER 10 MINUTES THE TROCAR BEGINS TO FAIL WITHOUT INSUFFLATION, IT IS VERIFIED AND IT IS OBSERVED THAT THE DUCKBILL SEAL IS DETACHED SO IT IS EXTRACTED. DEVICE REPLACED AND PROCEDURE CONTINUED WITH 15 MINUTE DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087859 ↗
• InjuryApr 9, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY, WHEN INDUCING THE TROCAR IN THE UMBILICAL SITE, BLOOD SPURTING FROM RIGHT COMMON ILEOARTERY WHEN VIEWING IT USING A CAMERA PORT. PROCEDURE WAS CONVERTED TO OPEN LAPAROTOMY TO SECURE BLEEDING. ON MARCH 27, PATIENT WAS FACING BOWEL INJURY AND HAD TO UNDERGO ANOTHER LAPAROTOMY. PATIENT IS STILL IN HOSPITAL CURRENTLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19069579 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WOULD ACTIVATE AND WOULD CLICK ON ENTRY, BUT THE BLADE WOULD NOT RETRACT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691916 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WOULD ACTIVATE AND WOULD CLICK ON ENTRY, BUT THE BLADE WOULD NOT RETRACT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691905 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WOULD ACTIVATE AND WOULD CLICK ON ENTRY, BUT THE BLADE WOULD NOT RETRACT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691892 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WOULD ACTIVATE AND WOULD CLICK ON ENTRY, BUT THE BLADE WOULD NOT RETRACT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691880 ↗
• MalfunctionJan 18, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A LOBECTOMY SURGERY (VATS APPROACH), WHEN TROCAR WAS REMOVED FROM PATIENT, IT WAS NOTICED TO BE BROKEN. SCANS IN THE SURGICAL FIELD WERE COMPLETED TO LOCATE AND REMOVE FRAGMENTS FROM PATIENTS BODY. THERE IS A POSSIBILITY THAT THEY WERE NOT ABLE TO GET ALL THE FRAGMENTS OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535706 ↗