ENDOPATH XCEL CB12LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10705036001331), received between Jan 16, 2018 and Sep 21, 2026 — classified as 11 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Crack” (17 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Delivered as Unsterile Product

  It was reported that during a Proctocolectomy surgery, before used on the patient, noted the packing 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 50838217 ↗
• MalfunctionJun 11, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE (GASTRIC BYPASS), THE TROCAR WAS PLACED AND USED ACCORDING TO STANDARD INSTRUCTIONS FOR USE. THE WHITE PLASTIC LUMEN IS LOCATED AT THE PROXIMAL OPENING OF THE TROCAR. AFTER PROLONGED USE OF 5 MM INSTRUMENTS WITHIN A 12 MM TROCAR, THE WHITE LUMEN REMAINED DISPLACED OFF-CENTER. UNDER NORMAL CONDITIONS, THE LUMEN SHOULD RETURN AUTOMATICALLY TO ITS ORIGINAL POSITION, IN WHICH IT IS NO LONGER VISIBLE AT THE OPENING. DUE TO THIS MALFUNCTION, THE LUMEN DID NOT IMMEDIATELY RETURN TO ITS NORMAL POSITION AFTER INSTRUMENT REMOVAL. AS A RESULT, INSERTION OF A 12 MM INSTRUMENT (SUCH AS A STAPLER) WAS NOT POSSIBLE WITHOUT ADDITIONAL MANIPULATION. THE LUMEN FIRST HAD TO BE MANUALLY REPOSITIONED (PUSHED BACK) BEFORE THE STAPLER COULD BE INSERTED AND POSITIONED CORRECTLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25475434 ↗
• MalfunctionApr 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING UNK PROCEDURE THE INNER PLASTIC SEAL POPPED OUT OF THE TROCAR SLEEVE AND WAS IN PATIENT. THERE ARE NO PATIENT HARM OR CONSEQUENCE REPORTED. THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048700 ↗
• MalfunctionJan 5, 2026Crack

  IT WAS REPORTED THAT DURING LAPAROSCOPIC PROMONTOFIXATION, IT WAS FOUND DURING THE DISARMING OF THE TROCAR, THE CRACK OF THE RING OF THE TROCAR LINER. AN IDENTICAL REFERENCE AND LOT DEVICE WAS USED AS A REPLACEMENT. THIS INCIDENT HAD NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956034 ↗
• MalfunctionSep 9, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTROPLASTY PROCEDURE THE RUBBER OF TROCAR CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003666 ↗
• MalfunctionMar 3, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, BEFORE 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 21509529 ↗
• MalfunctionNov 20, 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 20736607 ↗
• MalfunctionOct 30, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE SLEEVE WAS BENT. CHANGED TO A NEW DEVICE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570820 ↗
• MalfunctionSep 10, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, USED AS A CAMERA PORT, THE VALVE CAME OFF AND FELL INTO THE PATIENT¿S BODY WHEN THE CAMERA WAS INSERTED. AFTER THAT, THE VALVE WAS REMOVED FROM THE PATIENT¿S BODY. 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 20180405 ↗
• MalfunctionJul 3, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE SURGICAL PROCEDURE IS CARRIED OUT WITHOUT ANY ISSUES. ALMOST AT THE END OF THE SURGERY, THE PIECE IS REMOVED FROM THE CAVITY, REMOVING THE TROCAR WITH THE CLIP AND THE BAG WITH THE PIECE THROUGH THE TRANSPARENT CANNULA, RELEASES EVERYTHING AND RE-INSERTS THE SHIRT WITHOUT THE PUNCH IN THE CAVITY. AT THE TIME OF MAKING A FINAL REVIEW OF THE PROCEDURE, THE DOCTOR INTRODUCES A LAPAROSCOPY FORCEPS AND THE DUCK BEAK SEAL FALLS INTO THE ABDOMINAL CAVITY. EXAMINATION IS DONE AND THE SEAL IS REMOVED FROM THE CAVITY TOGETHER WITH THE 12 MM SHIRT, REMOVING THE PRODUCT FROM THE SURGICAL FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667501 ↗
• MalfunctionMar 13, 2024Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS NOTICED THE VALVE OF THE TROCAR WAS LOOSE AND AIR LEAKED. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896502 ↗
• MalfunctionMar 5, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SILICON ON THE INSIDE OF THE TROCAR WAS NOT CUT PROPERLY WHICH WASN'T ALLOWING INSTRUMENTS TO BE ABLE TO PASS THROUGH. REPLACED WITH ANOTHER DEVICE TO PROCEED WITH THE CASE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838750 ↗
• MalfunctionDec 1, 2023Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, SLEEVE FELL OFF AFTER OPENED THE PACKING. CHANGED TO A NEW DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246870 ↗
• InjuryAug 30, 2023Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ENDOCUTTER COULD NOT BE REMOVED FROM THE TROCAR. THE SURGEON TRIED MANY TIMES TO REMOVE THE DEVICE BUT ALL FAILED. FINALLY CHANGE TO OPEN OPERATION AND REMOVE THE ENDOCUTTER AND TROCAR TOGETHER.

  Patient problems: Insufficient Information

  MAUDE report 17653293 ↗
• InjuryAug 15, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE LOST ONE OF ITS MEMBRANES IN THE PATIENT CAVITY. MAY HAVE CAUSED A FOREIGN BODY TO BE LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549950 ↗
• MalfunctionJul 7, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE THE SURGERY, IT WAS NOTED THE PACKING WAS DAMAGED. CHANGED TO A DIFFERENT DEVICE, THE SAME PROBLEM HAPPENED AGAIN. 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 17279680 ↗
• MalfunctionJun 27, 2023Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  IT WAS REPORTED THAT THE DISTRIBUTOR RECEIVED STOCK OF CB12LT WHICH WAS SOILED AND IN NON SALEABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213978 ↗
• InjuryApr 7, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A RUPTURE OF THE DEVICE IN DISTAL PROXIMITY WITH CONSEQUENT LOSS OF A PIECE IN THE ABDOMEN, THAT WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16700798 ↗
• MalfunctionApr 5, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE 12 MM TROCAR MATERIAL WAS DEFECTIVE. ACCORDING TO THE SURGEON POSSIBLY DUE TO "THICKNESS OF THE ABDOMINAL WALL AND LOW COMPLACENT OF IT". FOR THIS REASON, IT WAS NECESSARY TO USE A NEW PRODUCT IN ORDER TO PROCEED WITH THE SURGERY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681735 ↗
• MalfunctionMar 28, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A VATS PROCEDURE, IT WAS DISCOVERED, WHILE MOVING THE CAMERA, THAT THE TROCAR WAS BROKEN WHILE INSIDE THE PATIENT. THE PIECE THAT BROKE OFF WAS RETRIEVED AND IT IS NOTED THAT NO EXTRA FORCE WAS NEEDED TO PLACE IT ORIGINALLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628576 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS THE PATIENT WAS SUBMITTED TO SURGERY AND PRESENTED AT THE END OF THE DAY AN EPISODE OF ABDOMINAL PAIN AND HYPOTENSION THAT RESPONDED WITH VOLUME EXPANSION AND ANALGESIA, THE FOLLOWING MORNING PRESENTED SYMPTOMS OF HYPOTENSION AND BLOOD COUNT WITH ANEMIA. IN ABDOMINAL TOMOGRAPHY, A MODERATE/LARGE AMOUNT OF FREE FLUID WAS EVIDENCED IN THE PERITONEAL CAVITY AND THE PATIENT WAS SUBMITTED TO BLOOD TRANSFUSION AND DIAGNOSTIC VIDEOLAPAROSCOPY. IN THIS SECOND PROCEDURE, A HEMOPERITONEUM WAS DIAGNOSED AND APPROXIMATELY 1.5L OF BLOOD AND CLOTS WAS ASPIRATED IN THE CAVITY, AND AN ACTIVE BLEEDING WAS OBSERVED AT THE EXCLUDING STOMACH STAPLING LINE, AND A STRENGTHENING SUTURE WAS REQUIRED IN THE REGION. AFTER THIS PROCEDURE, THE PATIENT HAD A FAVORABLE EVOLUTION AND WAS DISCHARGED AFTER 48H OF THE REINTERVENTION.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Low Blood Pressure/ Hypotension; Pain

  MAUDE report 16539320 ↗
• MalfunctionJan 26, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING A GASTRIC PROCEDURE, WHEN OPENING THE KIT, IT WAS IDENTIFIED THAT THE CANNULA PACKAGING WAS TORN, AND IT WAS NECESSARY TO CHANGE THE MATERIAL. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246728 ↗
• InjuryJan 24, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A NEPHRECTOMY, WHEN REMOVING THE TROCAR AT THE END OF THE PROCEDURE, IT WAS NOTED IT WAS BROKEN. THE SURGEON THEN LOOKED FOR THE BROKEN PIECES, AND SUCCESSFULLY REMOVED MOST OF THE MISSING PIECES. A SMALL, LESS THAN 1 MILLIMETER, PIECE WAS NOT ABLE TO BE FOUND AND WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16235463 ↗
• MalfunctionOct 27, 2022Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BEFORE THE SURGERY, SLEEVE FELL OFF AFTER OPENED THE PACKING. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WERE NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681999 ↗
• MalfunctionOct 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A HERNIA REPAIR, DAMAGE WAS NOTICED ON THE TOP SEAL; PART OF THE DEVICE HAD BROKEN OFF INTO THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624489 ↗