LIGACLIP LT200Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10705036012801), received between Jan 4, 2018 and Jan 16, 2026 — classified as 8 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (45 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN INSTALLING CLIP WITH APPLIER, CLIP IS CROOKED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096739 ↗
• MalfunctionJan 16, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN INSTALLING CLIP WITH APPLIER, CLIP IS CROOKED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096731 ↗
• MalfunctionJan 16, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN INSTALLING CLIP WITH APPLIER, CLIP IS CROOKED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096709 ↗
• MalfunctionJan 15, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE SCISSORING EFFECT SEEN IN THE APPLICATORS. THE PROCEDURE WAS DELAYED BY 10 MINUTES AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082253 ↗
• MalfunctionNov 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CLIPS ARE SLIPPING AND NOT HOLDING SECURELY ON VESSELS DURING PROCEDURES. NO OTHER DETAILS PROVIDED. NO PATEINT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638374 ↗
• MalfunctionJun 3, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN OPENED, THE NAIL CLIPS ARE ALL SCATTERED ON THE OPERATING TABLE, AND THE NAIL CLIPS ARE MANUALLY FIXED ON THE CLAMPING FORCEPS, AND THE TISSUE IS TRIED TO CLAMP, BUT BECAUSE THE NAIL CLAMPS ARE TOO LOOSE, THE TISSUE CAN NOT BE FIXED AND CLAMPED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131269 ↗
• MalfunctionMar 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP DOESN'T SCREW ON TIGHTLY, SO THE CLIP IS MOUNTED AT AN ANGLE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652170 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DEVICE HAS ASYMMETRICAL JAWS AND THE CLIPS ARE NOT FORMED PROPERLY.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20833030 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DEVICE HAS ASYMMETRICAL JAWS AND THE CLIPS ARE NOT FORMED PROPERLY.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20833017 ↗
• MalfunctionNov 19, 2024Failure to Form Staple; Defective Device; Failure to Form Staple; Defective Device

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, STAPLES TACK TOGETHER AT AN ANGLE AND THE WHITE HOUSINGS IN WHICH THE STAPLES ARE INSERTED ARE COMING APART. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727009 ↗
• MalfunctionNov 19, 2024Failure to Form Staple; Defective Device; Failure to Form Staple; Defective Device

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, STAPLES TACK TOGETHER AT AN ANGLE AND THE WHITE HOUSINGS IN WHICH THE STAPLES ARE INSERTED IS COMING APART. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725226 ↗
• MalfunctionOct 16, 2024Failure to Form Staple; Defective Device; Failure to Form Staple; Defective Device

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIPS NOT MAINTAINING INTEGRITY CARTRIDGE BREAKING IN HALF AND CLIPS FALLING OUT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466497 ↗
• MalfunctionSep 24, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE LT200 LIGA CLIPS BROKE WHILE FIRING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292278 ↗
• MalfunctionSep 24, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE LT200 LIGA CLIPS BROKE WHILE FIRING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292227 ↗
• MalfunctionSep 24, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE LT200 LIGA CLIPS BROKE WHILE FIRING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292183 ↗
• MalfunctionSep 24, 2024Mechanical Problem; Failure to Form Staple; Mechanical Problem; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE LT200 LIGA CLIPS BROKE WHILE FIRING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292096 ↗
• MalfunctionSep 24, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE LT200 LIGA CLIPS BROKE WHILE FIRING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292092 ↗
• MalfunctionSep 24, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE LT200 LIGA CLIPS BROKE WHILE FIRING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292009 ↗
• MalfunctionAug 8, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS BREAK. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938429 ↗
• MalfunctionDec 22, 2023Unintended Ejection; Difficult to Insert; Manufacturing, Packaging or Shipping Problem; Unintended Ejection; Difficult to Insert; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING A MASTECTOMY PROCEDURE, WHEN REMOVE THE CLIP BANK FROM THE STERILE PACKAGING, IT ALREADY FALLS APART. THE CLIPS CAN THEN NO LONGER BE PROPERLY LOADED. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME LIKE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388591 ↗
• MalfunctionDec 15, 2023Difficult to Insert; Failure to Form Staple; Difficult to Insert; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP WAS MALFORMED. THE CLIP COULD NOT BE FED INTO THE JAW PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336666 ↗
• MalfunctionNov 30, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIP COULD NOT CLOSE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCE REPORTED, NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239898 ↗
• MalfunctionNov 9, 2023Unintended Ejection; Failure to Form Staple; Unintended Ejection; Failure to Form Staple

  IT WAS REPORTED THAT DURING A VASECTOMY PROCEDURE, THE NEEDED TO TAKE OUT EXTRA MAGAZINES OF CLIPS. THE CLIPS WHERE SOMETIMES FORMED AN "S" ALREADY IN THE MAGAZINE, SOMETIMES THE CLIPS JUST FELL OUT OF THE MAGAZINE. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104965 ↗
• MalfunctionNov 9, 2023Unintended Ejection; Failure to Form Staple; Unintended Ejection; Failure to Form Staple

  IT WAS REPORTED THAT DURING A VASECTOMY PROCEDURE, THE NEEDED TO TAKE OUT EXTRA MAGAZINES OF CLIPS. THE CLIPS WHERE SOMETIMES FORMED AN "S" ALREADY IN THE MAGAZINE, SOMETIMES THE CLIPS JUST FELL OUT OF THE MAGAZINE. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104850 ↗
• MalfunctionNov 9, 2023Unintended Ejection; Failure to Form Staple; Unintended Ejection; Failure to Form Staple

  IT WAS REPORTED THAT DURING A VASECTOMY PROCEDURE, THE NEEDED TO TAKE OUT EXTRA MAGAZINES OF CLIPS. THE CLIPS WHERE SOMETIMES FORMED AN "S" ALREADY IN THE MAGAZINE, SOMETIMES THE CLIPS JUST FELL OUT OF THE MAGAZINE. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104439 ↗

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-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
• 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