ENDOPATH XCEL CB5LTRecalls & reported problems
Ethicon Endo-Surgery, LLC · ENDOPATH XCEL Universal Trocar Stablility Sleeves · Class 2
Quick summary
This is an Ethicon ENDOPATH XCEL trocar stability sleeve, a single-use port sleeve used in laparoscopic surgery. The 75 reports mostly describe packaging that arrives unsterile or damaged, plus sleeves that crack or break — including one that snapped in half while being tunneled under the skin and had to be removed by the surgical team. Reports mention 1 death and 4 injuries. No recalls name this device. Reports dropped sharply, from 42 in the prior 12 months to 5 in the last12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 75
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10705036001348), received between Sep 19, 2013 and Mar 25, 2026 — classified as 1 death, 4 injuries, 70 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (50 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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product50
- Crack12
- Tear, Rip or Hole in Device Packaging5
- Break4
- Gas/Air Leak4
- Device Markings/Labelling Problem2
- Component or Accessory Incompatibility1
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- No Consequences Or Impact To Patient9
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE COSTUMER WAS COMPLAINING OF PACKAGING STERILITY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691506 ↗MalfunctionMar 25, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE COSTUMER WAS COMPLAINING OF PACKAGING STERILITY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691497 ↗MalfunctionMar 25, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE COSTUMER WAS COMPLAINING OF PACKAGING STERILITY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691488 ↗MalfunctionMar 25, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE COSTUMER WAS COMPLAINING OF PACKAGING STERILITY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691464 ↗MalfunctionMar 25, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE COSTUMER WAS COMPLAINING OF PACKAGING STERILITY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691442 ↗MalfunctionOct 28, 2025Crack; Crack
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A 5MM X 100MM UNIVERSAL TROCAR STABILITY SLEEVE (ENDOPATH XCEL REF (B)(4)) BROKE IN HALF WHILE THEY ARE TUNNELLING IT UNDER THE SKIN GOING TO THE NECK CAVITY. THE CONSULTANT SURGEON AND THE ASSISTANT SURGEON SUCCEED IN CAREFULLY REMOVING THE PART OF THE TROCAR THAT GOT STUCK UNDER THE SKIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402153 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292453 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292449 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292447 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292416 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292344 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292335 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292332 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292268 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292266 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292264 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292262 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292257 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292254 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292093 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292084 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289331 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289330 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289299 ↗MalfunctionJun 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING IS NOT STERILE. THERE IS A STERILITY ISSUE ON THE PACKAGING. THERE ARE BUMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289296 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.