LIGACLIP LX210Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20705036012907), received between Apr 13, 2018 and Dec 11, 2025 — classified as 12 malfunctions.

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

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Failure to Form Staple; Failure 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 23777779 ↗
• MalfunctionOct 30, 2025Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE CLIP BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423522 ↗
• MalfunctionMar 20, 2025Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TIP IS DIFFICULT TO BITE DOWN ON. IT WON'T GO BACK AFTER BITING. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653059 ↗
• MalfunctionOct 26, 2023Failure to Form Staple; Material Integrity Problem; Failure to Form Staple; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIP APPLIER WILL NO LONGER HOLD THE CLIPS AND THE COATING IS CRACKED ON THE HANDLE AND A FEW THE TIPS ARE CROSSED. THERE WAS NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011525 ↗
• MalfunctionJul 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE, THE CLIPS WOULD LOAD INTO THE JAW, BUT FALL OFF WHEN APPLIED TO THE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398228 ↗
• MalfunctionDec 17, 2020Mechanical Problem; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP APPLIER DIDN'T APPLY PROPER CLIPS. THE JAWS WERE SPOILED. USER REPORTED THE CLIPS ARE NOT BROKEN, THE CLIP APPLIER DIDN'T HOLD THE CLIPS. CLIP APPLIER JAWS WERE BROKEN SO THEY DIDN'T HOLD THE CLIPS AND BECAUSE THE CLIP APPLIER JAWS WERE BROKEN, IT DIDN'T MAKE THE CLIPS HOLD THE VEIN, OR TISSUE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11033519 ↗
• MalfunctionDec 17, 2020Mechanical Problem; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP APPLIER DIDN'T APPLY PROPER CLIPS. THE JAWS WERE SPOILED. USER REPORTED THE CLIPS ARE NOT BROKEN, THE CLIP APPLIER DIDN'T HOLD THE CLIPS. CLIP APPLIER JAWS WERE BROKEN SO THEY DIDN'T HOLD THE CLIPS AND BECAUSE THE CLIP APPLIER JAWS WERE BROKEN, IT DIDN'T MAKE THE CLIPS HOLD THE VEIN OR TISSUE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11033319 ↗
• MalfunctionDec 17, 2020Mechanical Problem; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP APPLIER DIDN'T APPLY PROPER CLIPS. THE JAWS WERE SPOILED. USER REPORTED THE CLIPS ARE NOT BROKEN, THE CLIP APPLIER DIDN'T HOLD THE CLIPS. CLIP APPLIER JAWS WERE BROKEN SO THEY DIDN'T HOLD THE CLIPS AND BECAUSE THE CLIP APPLIER JAWS WERE BROKEN, IT DIDN'T MAKE THE CLIPS HOLD THE VEIN OR TISSUE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11033294 ↗
• MalfunctionDec 17, 2020Mechanical Problem; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP APPLIER DIDN'T APPLY PROPER CLIPS. THE JAWS WERE SPOILED. USER REPORTED THE CLIPS ARE NOT BROKEN, THE CLIP APPLIER DIDN'T HOLD THE CLIPS. CLIP APPLIER JAWS WERE BROKEN SO THEY DIDN'T HOLD THE CLIPS AND BECAUSE THE CLIP APPLIER JAWS WERE BROKEN, IT DIDN'T MAKE THE CLIPS HOLD THE VEIN OR TISSUE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11033260 ↗
• MalfunctionAug 5, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A "BROKEN APPLIER, SINGLE CLIP MEDIUM, WHITE 10 ½¿ (LX 210)". THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370100 ↗
• MalfunctionApr 13, 2018Break

  IT WAS REPORTED THAT THE JAW IS DAMAGED BEYOND REPAIR. THERE WAS NO PROCEDURE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429248 ↗
• MalfunctionApr 13, 2018Break

  IT WAS REPORTED THAT THE JAW IS DAMAGED BEYOND REPAIR. THERE WAS NO PROCEDURE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7428278 ↗