LIGACLIP EL214Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705036003844), received between Jan 16, 2020 and Jun 24, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (3 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2022Difficult to Insert; Failure to Form Staple; Difficult to Insert; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE EL214 DID NOT ALLOW CLIPS TO LOAD PROPERLY AND CLIP ON VESSELS PROPERLY INTRA OP. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799799 ↗
• MalfunctionJun 24, 2020Failure to Form Staple; Material Integrity Problem; Failure to Form Staple; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, "JOE'S LOOSE AND CLIP CANNOT BE LIGATED." THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE CUSTOMER DOES NOT WANT TO PROVIDE ADDITIONAL INFORMATION ABOUT THIS PC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10193144 ↗
• MalfunctionMay 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP WAS NOT PROPERLY FITTED INTO THE CLIP APPLIER. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10022576 ↗
• MalfunctionJan 16, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN SURGEON APPLIED EACH CLIP (LT200) TO VESSEL, SURGEON COULD SEE CLIPS WERE NOT FULLY CLOSED AND CLIPPED FROM LIGATED VESSEL. "ANOTHER APPLIER WASN'T MADE THIS PROBLEM BUT ONLY HAPPENED IT FROM THIS PRODUCT." IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED AND PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9598832 ↗