ENDOPATH XCEL D5STRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath XCEL Dilating Tip 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 10705036001607), received between Feb 10, 2020 and Mar 13, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Crack1
- Physical Resistance/Sticking1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2024Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TIP OF THE TROCAR CRUMBLED AND LEFT PIECES OF PLASTIC IN THE ABDOMEN. USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18897679 ↗MalfunctionFeb 11, 2020Physical Resistance/Sticking
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SHIELD RESET BUTTON WAS NON-FUNCTIONAL WHEN INSERTING THROUGH THE "PERITONEAL." "PATIENT WAS REPORTED TO BE OK."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9693979 ↗MalfunctionFeb 10, 2020Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING HAD A HOLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9691014 ↗
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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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