ENDOPATH XCEL B12LTHRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath XCEL Bladeless Trocars with Stability Sleeves · Class 2
All models of ENDOPATH XCEL (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705036001171), received between Mar 14, 2023 and Aug 18, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299260 ↗MalfunctionFeb 9, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, INSIDE THE TROCAR, IN THE INNER PART THERE WAS LOOSE PLASTIC. CASE COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18676606 ↗MalfunctionMar 14, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A PART OF THE RUBBER VALVE BROKE AND THIS PLASTIC PART ENDED UP IN THE PATIENT¿S ABDOMEN. THE PLASTIC WAS RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16539375 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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