ENDOPATH XCEL K12LTRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath XCEL Dilating Tip Trocar Paks containing: 1 Dilating Tip trocar with Stability Sleeve and 1 Stability Sleeve for Dilating Tip Trocar · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705036002284), received between May 20, 2022 and May 20, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022Material Separation; Material Separation
IT WAS REPORTED THAT DURING A BARIATRIC GASTRIC SLEEVE RESECTION THE TROCAR K12LT WAS BROKEN DURING SKIN PENETRATION. IT DIDN'T WORK PROPERLY AND SURGEON REPLACED IT WITH K11LT. THERE WAS A 15 MINUTE DELAY TO SURGERY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14459122 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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