LIGACLIP LT100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705036012788), received between Jun 28, 2018 and Mar 30, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (6 reports).

3 other recalls cover devices cleared under the same FDA submission (K830503); they may or may not involve this specific model.

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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, ONE OF THE CLIPS BROKE WHEN PLACING ON A VESSEL BEFORE TRANSECTION. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729093 ↗
• MalfunctionDec 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK PROCEDURE, THE NAIL IN THE STAPLER SUDDENLY BROKE. CHANGED ANOTHER ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767132 ↗
• MalfunctionJun 23, 2025Use of Device Problem; Failure to Form Staple; Use of Device Problem; Failure to Form Staple

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE THE CARDIAC SURGERY CLAIMS THAT DURING THE SURGICAL PROCEDURE THE CLIP DOES NOT WORK CORRECTLY, IT DOES NOT GRIP AS IT SHOULD, THE LEGS OF THE CLIP CROSS AND DURING THE PROCEDURE THE CLIP COMES LOOSE. THE CLIPPER IS NOT JOHNSON. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306607 ↗
• MalfunctionDec 8, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIP WAS LOOSE AND DEVICE CAN'T HOLD TIGHTLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291670 ↗
• InjuryJul 12, 2023Unintended Ejection; Failure to Form Staple; No Apparent Adverse Event; Unintended Ejection; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CABG PROCEDURE, CLIPS ARE COMING OUT OF THE CARTRIDGES. WHEN APPLYING CLIPS ON VESSELS, CLIPS ARE FALLING OUT OF APPLICATOR. SOME CLIPS ARE NOT GETTING APPLIED ON ARTERY OR VEIN, CAUSING BLEEDING AND OOZING. PROCEDURE DELAYED 120 MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17311616 ↗
• MalfunctionNov 11, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FIRED BUT CLIP/STAPLE WAS NOT FORMED COMPLETELY. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801452 ↗
• MalfunctionMar 17, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE LT100 CLIPS CREATED UNWANTED SECTIONING OR TEARING OF VESSELS TO WHICH THEY WERE APPLIED. PROCEDURE WAS DELAYED BY FIFTEEN MINUTES HOWEVER PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510144 ↗
• MalfunctionJul 9, 2018Difficult to Open or Close

  THE CLIPS DO NOT CLOSE PROPERLY WITH CONSEQUENT ISSUE FOR THE HEMOSTASIS. PROCEDURE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669211 ↗
• MalfunctionJun 28, 2018Detachment Of Device Component

  AFTER THE APPLICATION THE CLIP DETACHED. THE ISSUE WAS SOLVED USING A NEW ONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7646908 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K830503. One submission often covers many models, so check the product and lot details in each record.

• Z-1775-2013 · Apr 12, 2013 · Terminated
  LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instru
• Z-1776-2013 · Apr 12, 2013 · Terminated
  LIGACLIP Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, sing
• Z-1777-2013 · Apr 12, 2013 · Terminated
  LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient us