ENDOPATH XCEL B12LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 10705036001164), received between Jan 16, 2018 and Sep 21, 2026 — classified as 17 injuries, 280 malfunctions.

The most frequently reported specific device problem is “Crack” (186 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 297 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846409 ↗
• MalfunctionSep 15, 2026Adverse Event Without Identified Device or Use Problem

  it was reported that during an Unknown procedure the defect noticed during surgery at the internal tip of the port. When brought to surgeon's attention,they stated that many have been why placing the port felt hard. Curve noticed outwards on the lipof the device.Patient Outcome/Consequences: N/A.No further information available as reporter details have not been disclosed (confidential).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772252 ↗
• MalfunctionSep 3, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591666 ↗
• MalfunctionMay 29, 2026Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN LAPAROSCOPY, AIR LEAKED FROM THE INTERNAL VALVE, AND PNEUMOPERITONEUM COULD NOT BE MAINTAINED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334819 ↗
• MalfunctionMay 21, 2026Material Integrity Problem

  B12LT USED IN A LAP CHOLE CASES. RUBBER VALVE DETACHED FROM TROCAR AND LANDED IN PATIENT'S ABDOMINAL SPACE, WHEN SURGEON WAS TRYING TO INSERT A GAUZE THROUGH THE TROCAR. FULL PIECE OF RUBBER VALVE WAS RECOVERED, CASE PROCEEDED WITH SECOND B12LT. ENDOPATH XCEL BLADELESS TROCAR (B12LT): SIDE AFFECTED: NOT APPLICABLE REASON PRODUCT IS NOT AVAILABLE: AVAILABLE LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO WAS THERE A SIGNIFICANT DELAY? IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247450 ↗
• MalfunctionMay 7, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, COULD NOT FIT SMOOTHLY INTO PATIENT. IT WAS REPORTED THAT DURING SURGERY, NOTED THE DEVICE COULD NOT FIT SMOOTHLY INTO PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25118822 ↗
• MalfunctionApr 8, 2026Crack

  IT WAS REPORTED THAT DURING BEFORE AN UNK PROCEDURE, CRACKING WAS OBSERVED ON B12LT TROCARS PRIOR TO REPROCESSING. SOME OF THE DEVICES OBSERVED WERE UNUSED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24822143 ↗
• MalfunctionApr 2, 2026Crack

  IT WAS REPORTED THAT DURING THE UNK SURGERY, NOTED THAT THE DEVICE WAS CRACKED. 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 24769885 ↗
• InjuryApr 2, 2026Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KANANI F, KOZIN M, BEN AVRAHAM Y, AVITAN E, GUREVICH M, NESHER E, GRAVETZ A. LAPAROSCOPIC LIVING DONOR NEPHRECTOMY: LEARNING CURVE ANALYSIS THROUGH 1446 CASES AND OUTCOMES FROM 200 CONSECUTIVE MASTERY-PHASE PROCEDURES-HOW I DO IT. J CLIN MED. 2026 FEB 9;15(4):1363. DOI: 10.3390/JCM15041363. PMID: 41753051; PMCID: PMC12941911. THE AIM OF THIS STUDY IS TO HIGH-VOLUME SINGLE-CENTER EXPERIENCE WITH STANDARDIZED TRANSPERITONEAL LAPAROSCOPIC DONOR NEPHRECTOMY AND CUSUM-BASED LEARNING CURVE ANALYSIS. BETWEEN (B)(6) 2015 AND (B)(6) 2024, A TOTAL OF 200 CONSECUTIVE LAPAROSCOPIC LIVING DONOR NEPHRECTOMIES WERE USING ETHICON ENDOPATH, ETHICON HARMONICACE® + SHEARSORHARMONIC SYNERGY® HOOK, ETHICON LIGACLIP®, ETHICON ECHELONFLEX¿, SURGICEL® ETHICON, 0-VICRYL, 4-0 MONOCRYL AND DERMABOND® (ETHICON). REPORTED COMPLICATIONS ARE N=8; CLAVIEN¿DINDO (GRADE I) TREATMENT: NOT MENTIONED N=3; CLAVIEN¿DINDO (GRADE II) TREATMENT: NOT MENTIONED N=1; CLAVIEN¿DINDO (GRADE=III) TREATMENT: NOT MENTIONED N=2; SUPERFICIAL SSI TREATMENT: NOT MENTIONED N=1; SEROMA TREATMENT: NOT MENTIONED N=1; INTRA-ABDOMINAL COLLECTION TREA

  Patient problems: Insufficient Information; Pain; Post Operative Wound Infection; Seroma; Urinary Retention

  MAUDE report 24769654 ↗
• MalfunctionMar 26, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, NOTED THE UNIVERSAL HAP LOOSE. CHANGED THE NEW ONE 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 24699957 ↗
• MalfunctionFeb 9, 2026Crack; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY, INTIMAL SHEET DEFECT DURING USE, EASY TO LEAK DURING OPERATION. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292581 ↗
• MalfunctionJan 8, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, UPON OPENING THE PACKAGE AND INSPECTING THE INSTRUMENT, THE SEALING FILM WAS FOUND TO BE 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 24010871 ↗
• MalfunctionDec 26, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE UNK SURGERY, THE SURGEON NOTED THE DEVICE HAD AIR LEAKAGE ISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, 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 23899364 ↗
• MalfunctionDec 17, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE VALVE IN THE TROCAR FALLS OUT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827869 ↗
• InjuryDec 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YUK FJ, CARR MT, SCHUPPER AJ, LIN J, TADROS R, WIKLUND P, SFAKIANOS J, STEINBERGER J. DA VINCI MEETS GLOBUS EXCELSIUS GPS: A TOTALLY ROBOTIC MINIMALLY INVASIVE ANTERIOR AND POSTERIOR LUMBAR FUSION. WORLD NEUROSURG. 2023 DEC;180:29-35. DOI: 10.1016/J.WNEU.2023.09.028. EPUB 2023 SEP 13. PMID: 37708971. THIS IS A CASE STUDY OF 65-YEAR-OLD MAN WITH CHRONIC LOW BACK PAIN AND LEFT GREATER THAN RIGHT LOWER EXTREMITY RADICULOPATHY WAS FOUND TO HAVE GRADE 1 SPONDYLOLISTHESIS AT L5/ S1 THAT WORSENED ON STANDING UPRIGHT. HE UNDERWENT ALIF (ANTERIOR LUMBAR INTERBODY FUSION) USING A DA VINCI ROBOTIC APPROACH, FOLLOWED BY PERCUTANEOUS POSTERIOR INSTRUMENTED FUSION WITH THE GLOBUS EXCELSIUS GPS ROBOT AND TWO 12- MM ETHICON 512 NT CAMERA PORTS, (JOHNSON & JOHNSON CO. SOMERVILLE, NEW JERSEY, USA). REPORTED COMPLICATIONS ARE N=1; 65 YEAR OLD-MAN. DEVELOPED A BRIEF EPISODE OF ILEUS FOR 2 DAYS. TREATMENT: STOOL SOFTENERS AND ENEMAS. IN CONCLUSION, WE REPORT ON THE FIRST ALL-ROBOTIC ALIF WITH POSTERIOR PERCUTANEOUS PEDICLE SCREW FIXATION, USING THE DA VINCI ROBOT FOR ANTERIO

  Patient problems: Obstruction/Occlusion

  MAUDE report 23696496 ↗
• MalfunctionOct 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LOWER ANTERIOR BOWEL RESECTION AND DURING CLEANING OF TROCAR USING GAUZE, THE GREY VALVE MATERIAL WAS TORN FROM INNER CIRCLE. A FRAGMENT WAS GENERATED BUT RETRIEVED. NEW PORT/TROCAR WAS OPENED AND REPLACED. THE SURGERY WAS DELAYED 3 MINUTES. REPLACED TROCAR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES, OTHER INFORMATION: CANNOT CONFIRM AT 100% IF THE SMALL CORNER REMAINED CAPTURED IN TROCAR OR IF IT FELL INTO PATIENT. NOTHING WAS IDENTIFIED THEREFORE ASSUMED IT WAS NOT LEFT IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412357 ↗
• MalfunctionOct 17, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BEFORE USED ON THE PATIENT, NOTED THE UNIVERSAL HAP LOOSE. CHANGED THE NEW ONE 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 23321852 ↗
• MalfunctionSep 11, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TROCAR COVER WAS NOT COUPLING PROPERLY, THAT IS, THERE WAS NO SEAL, AND THE TROCAR WAS NECESSARY TO REPLACE IT FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025100 ↗
• MalfunctionAug 18, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TROCAR COVER WAS NOT COUPLING PROPERLY, THAT IS, THERE WAS NO SEAL. IT WAS NECESSARY TO REPLACE THE DEVICE TO PERFORM THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827214 ↗
• MalfunctionAug 12, 2025Crack; Crack

  IT WAS REPORTED THAT BEFORE AN UNKNOWN SURGERY, NOTED THE DEVICE WAS BROKEN . ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781860 ↗
• MalfunctionJul 7, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE CONTAMINATED. IT WAS REPORTED THAT BEFORE THE SURGERY, OPEN THE PACKING AND NOTED THE DEVICE CONTAMINATED. 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 22411350 ↗
• MalfunctionMay 28, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE OUTSIDE OF TROCAR TUBE WAS BEDING SO IT WAS NOT POSSIBLE TO INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095441 ↗
• MalfunctionApr 17, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE UNKNOWN SURGERY, CRACKS WERE NOTED ON THE SEAL. CHANGED THE NEW ONE 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 21857862 ↗
• MalfunctionMar 25, 2025Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, RUBBER OF THE TROCAR LOOSENED AND BEGAN AN AIR LEAK. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690584 ↗
• MalfunctionMar 19, 2025Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SLEEVE FELL OFF AFTER OPENING 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 21646901 ↗