ENDOPATH XCEL D11LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705036001560), received between Dec 15, 2017 and Mar 23, 2026 — classified as 1 death, 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (9 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, PRESENTED A DEFECT IN THE SEALING PETAL VALVE AT THE TIME OF PUNCTURE BY THE SURGEON, AND IT WAS NECESSARY TO OPEN A NEW TROCAR TO PROCEED WITH THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24667404 ↗
• MalfunctionOct 29, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WE FOUND DETACHMENT OF THE PRIMARY PACKAGING, WHICH CAUSED CONTAMINATION OF THE PRODUCT AND MADE IT IMPOSSIBLE TO USE SAFELY IN SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413075 ↗
• 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 22770756 ↗
• 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 22770749 ↗
• 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 22770748 ↗
• MalfunctionJul 17, 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 22530313 ↗
• DeathDec 31, 2024Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SEVERE EVENT, PATIENT DEATH, WITH VASCULAR TRAUMA TO THE LEFT ILIAC DURING THE FIRST PUNCTURE WITH DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 21048030 ↗
• MalfunctionOct 2, 2024Crack; Crack

  IT WAS REPORTED THAT PRE-OPERATION TO AN UNKNOWN PROCEDURE, IT WAS FOUND THE TROCAR TIP WAS DAMAGED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350924 ↗
• MalfunctionJul 3, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED LAPAROSCOPIC PROCEDURE; THE TIP OF THE TROCAR PARTIALLY BROKE WHILE IN THE PATIENT. IT WAS TURNED INWARD AND BLOCKING THE CAMERA/TOOL FROM ADVANCING WITHIN THE TROCAR. REMOVED THE TROCAR AND BROKE OFF A PORTION OF THE TROCAR USING A HEMOSTAT. THERE WAS NO PATIENT CONSEQUENCES REPORTED. UNKNOWN IF SURGERY WAS COMPLETED SUCCESSFULLY. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667422 ↗
• MalfunctionMay 23, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE TROCAR WAS OPENED IT WAS FOUND THAT THE TIP WAS BENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382423 ↗
• MalfunctionMay 21, 2024Material Separation; Component or Accessory Incompatibility; Material Separation; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN INSERTING INTO THE TROCAR, IT DOES NOT FIT. TRIED INSERTING MULTIPLE TIMES AND FRACTURED WHEN FORCED HARDER. NO PATIENT CONSEQUENCES. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359087 ↗
• MalfunctionDec 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ADHESIVE PART OF THE PACKAGING IS OPEN. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312116 ↗
• MalfunctionNov 10, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR WAS BROKEN. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112273 ↗
• MalfunctionJun 2, 2022Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY AND AFTER OPENING THE PACKAGING, IT WAS OBSERVED THAT THE TIP OF THE CANNULA HAD A FOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14576904 ↗
• MalfunctionJun 1, 2022Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING A OOPHORECTOMY, THE PRODUCT SHOWED AIR LEAKAGE IN THE RUBBER (RUBBER RUNNING INSIDE THE TROCAR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565010 ↗
• MalfunctionNov 2, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OVARIAN CYST REMOVAL PROCEDURE, BEFORE CLOSING THE PATIENT, THE SURGEON FOUND SMALL RUBBER CIRCLE-SHAPED PIECES OF THE TROCAR WERE DETACHED FROM THE PRODUCT AND WERE FOUND IN THE BODY. THE SURGEON REMOVED ALL PIECES FROM THE PATIENT. THE PATIENT IS FINE AND DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738074 ↗
• MalfunctionOct 20, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE HOSPITAL COMPLAINED THERE WAS NO CLEAR MARKING ON THE BOX TO INDICATE WHAT PRODUCTS WERE INSIDE, AND THE WRONG BOX WAS OPENED IN THEATRE. THIS PRODUCT WAS NOT USED IN CASE AND A NEW KIT WAS OPENED. THERE WAS NO HARM TO THE PATIENT AND APPROXIMATELY TWO MINUTES OF THEATRE TIME WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669470 ↗
• MalfunctionApr 15, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE, THE PACKAGE WAS NOTED TO HAVE A TEAR. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11674945 ↗
• MalfunctionFeb 23, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE "SHADE" COULD NOT BE RETRACTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369722 ↗
• MalfunctionOct 6, 2020Component Missing; Material Integrity Problem; Component Missing; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPY PROCEDURE, IT WAS OBSERVED IN THE TROCAR THAT THE FITTING PIECE ABOVE THE UNIDIRECTIONAL VALVE WAS MISSING. THE PRODUCT WAS REPLACED AND DID NOT CAUSE ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10636167 ↗
• MalfunctionSep 30, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS NOTICE PRIOR TO AN UNKNOWN PROCEDURE (PREOP) THAT THE XCEL TROCAR PACKAGING WAS DAMAGED AND NOT GLUED WELL ON SIDE OF PACKAGING. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10610452 ↗
• MalfunctionSep 30, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS NOTICE PRIOR TO AN UNKNOWN PROCEDURE (PREOP) THAT THE XCEL TROCAR PACKAGING WAS DAMAGED, AND NOT GLUED WELL ON SIDE OF PACKAGING. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10610425 ↗
• MalfunctionSep 30, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS NOTICE PRIOR TO AN UNKNOWN PROCEDURE (PREOP) THAT THE XCEL TROCAR PACKAGING WAS DAMAGED AND NOT GLUED WELL ON SIDE OF PACKAGING. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10610376 ↗
• MalfunctionJan 10, 2020Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRODUCT WAS IN STOCK OF FINISHED PRODUCTS AT DISTRIBUTOR AND WHEN SORTING FOR SHIPPING TO THE CUSTOMER, IT WAS NOTED THAT THE PAPER POUCH HAD A HOLE. IN EVALUATING, IT WAS NOTED A SMALL BULGE OF THE PRODUCT, WHICH MAY HAVE CAUSED THE HOLE IN THE PACKAGING, LOSING ITS STERILITY. THIS SMALL BULGE MAY HAVE CAUSED THE HOLE DUE TO FRICTION WITH THE POUCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575067 ↗
• MalfunctionJan 3, 2020Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE TROCAR CAME WITH A BENT VALVE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547581 ↗