ENDOPATH XCEL B15LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705036001201), received between Feb 26, 2018 and Apr 23, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Component or Accessory Incompatibility; Material Integrity Problem; Component or Accessory Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAP SLEEVE GASTRECTOMY, THE SURGEON NOTED THAT THE FLOATING GASKET IN THE HOUSING OF THE TROCAR WAS GETTING STUCK IN KIND OF A LATERAL POSITION ONCE THEY WERE USING A 5MM INSTRUMENT. WHEN THEY WENT TO USE 12MM STAPLER WOULD NOT GO IN. THEY HAD TO CENTER THE GASKET WITH THEIR FINGER TO GET THE STAPLER IN. THE SURGEON REFERENCED BUT DID NOT REFERENCE HOW MANY TIMES. THAT THIS SAME EVENT HAS OCCURRED IN OTHER CASES. CASE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894831 ↗
• MalfunctionNov 6, 2024Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN GYNECOLOGICAL PROCEDURE, TROCAR DID NOT FIT INSIDE SLEEVE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622292 ↗
• MalfunctionJul 2, 2024Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE15MM TROCAR OBTURATOR DOES NOT FIT IN CANNULA. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660169 ↗
• MalfunctionMay 9, 2024Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TROCAR WILL NOT FIT INTO SHEATH. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281770 ↗
• MalfunctionApr 16, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SEAL WAS NOT WORKING ON THE TROCAR. CASE WAS COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119070 ↗
• MalfunctionJun 19, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17154500 ↗
• MalfunctionFeb 23, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TROCAR VALVE WAS DEFECTIVE AND WOULD NOT SEAL. THE PROCEDURE SUCCESSFULLY COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428995 ↗
• MalfunctionApr 11, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A HYSTERECTOMY THE DISTAL PORTION OF THE SLEEVE PRESENTS A RUPTURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14078788 ↗
• MalfunctionSep 11, 2019Break; Entrapment of Device

  SEE USER FACILITY MEDWATCH NUMBER: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8997485 ↗
• MalfunctionMar 29, 2019Break; Material Separation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROSTATECTOMY SURGERY, ENDOPATH XCEL TROCAR UNIVERSAL SEAL WAS BROKEN AND ONE PIECE OF THIS SEAL WAS FOUND SEPARATELY FROM THE OPERATION SITE. DARK GRAY LEAFLET ON THE INSIDE OF THE UNIVERSAL SEAL BECOME BROKEN. THIS PIECE OF SEAL WAS REMOVED, AND SURGERY CONTINUED IN USUAL MANNER. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464897 ↗
• MalfunctionJul 31, 2018Leak/Splash

  IT WAS REPORTED BY THE ACCOUNT CONTACT THAT THE DEVICE WAS LEAKING FROM A BAD SEAL. THERE WERE NO REPORTED PATIENT CONSEQUENCES. PROCEDURE: LAP GASTRIC SLEEVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7735583 ↗
• MalfunctionFeb 26, 2018Component Falling

  IT WAS REPORTED THAT DURING A ROBOTIC CYSTO PROSTATECTOMY THE INNER BLACK SEAL OF THE TROCAR FELL OUT AND INTO THE PATIENT. THE BLACK SEAL WAS RETRIEVED FROM THE PATIENT. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. IT ISN'T KNOWN IF THE BLACK SEAL WILL BE RETURNED WITH THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7295855 ↗