LIGACLIP LX207Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 20705036012891), received between Apr 16, 2018 and Sep 16, 2026 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (24 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788303 ↗
• MalfunctionFeb 10, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, FUNCTIONAL ISSUES WITH ALL FIVE CLIP APPLIERS IN THE LOT. SPECIFICALLY, THE LAPRA-TY DEVICES DID NOT SEAT PROPERLY ON THE JAWS AND WOULD NOT CLOSE OR LOCK AS INTENDED. IN ADDITION, BOTH THE HEM-O-LOCK BLUE CLIP APPLIERS AND THE WHITE CLIP APPLIERS WERE UNABLE TO HOLD THE CLIPS SECURELY AND WERE NOTED TO BE MISALIGNED. NO PATIENT CONSEQUENCE WERE REPORTED IN ASSOCIATION WITH THESE FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305508 ↗
• MalfunctionFeb 10, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, FUNCTIONAL ISSUES WITH ALL FIVE CLIP APPLIERS IN THE LOT. SPECIFICALLY, THE LAPRA-TY DEVICES DID NOT SEAT PROPERLY ON THE JAWS AND WOULD NOT CLOSE OR LOCK AS INTENDED. IN ADDITION, BOTH THE HEM-O-LOCK BLUE CLIP APPLIERS AND THE WHITE CLIP APPLIERS WERE UNABLE TO HOLD THE CLIPS SECURELY AND WERE NOTED TO BE MISALIGNED. NO PATIENT CONSEQUENCE WERE REPORTED IN ASSOCIATION WITH THESE FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305420 ↗
• MalfunctionOct 30, 2025Mechanical Problem; Mechanical Problem

  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 23423527 ↗
• MalfunctionOct 30, 2025Mechanical Problem; Mechanical Problem

  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 23423525 ↗
• MalfunctionApr 24, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DEVICE GETTING STUCK IN BETWEEN WHILE LODGING THE CLIPS, IT WAS NOT OPENING BACK ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901020 ↗
• InjuryNov 19, 2024Mechanical Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  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 20725214 ↗
• MalfunctionNov 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A GASTRECTOMY, CLIPS WERE OPENING UP. 15 PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233766 ↗
• MalfunctionNov 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A GASTRECTOMY, CLIPS WERE OPENING UP. 15 PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233755 ↗
• 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 18011513 ↗
• MalfunctionSep 21, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS DO NOT BITE WELL. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17790844 ↗
• MalfunctionAug 7, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WERE MISALIGNED/BENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477168 ↗
• MalfunctionAug 7, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WERE MISALIGNED/BENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477151 ↗
• MalfunctionAug 7, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WERE MISALIGNED/BENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477135 ↗
• MalfunctionAug 5, 2021Mechanical Problem; Failure to Form Staple; Mechanical Problem; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE HAD LACK OF BITE AND FAULTY CLIP FORMATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285574 ↗
• MalfunctionNov 13, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE FORMATION OF THE CLIPS WAS NOT OPTIMAL. THE LEGS DIDN'T CLOSE SYMMETRICALLY, WHICH LEAVES A SMALL PORTION OF THE LEG WITH NO COMPRESSION. SEVERAL CLIPS HAD TO BE USED TO OBTAIN HEMOSTASIS. THE CLIP FORMATION IN CLIP APPLIER WAS NOT OPTIMAL, THE LEGS DON¿T CLOSE SYMMETRICALLY, WHICH LEAVES A PORTION OF THE TISSUE WITH NO COMPRESSION. THE PORTION WITH NO COMPRESSION WAS MILLIMETRIC. THERE WAS NO DELAY TO PROCEDURE, SURGERY WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10836312 ↗
• MalfunctionAug 5, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE APPLICATOR CONTROLLER DOES NOT TIGHTEN THE STAPLE COMPLETELY. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370001 ↗
• MalfunctionMay 27, 2020Mechanical Problem; Failure to Form Staple; Mechanical Problem; Failure to Form Staple

  IT WAS REPORTED BY SENIOR OPERATING NURSE THAT THERE WAS A DEFECT IN THE WORKING PART OF THE CLIP APPLIER (DIFFERENT JAW LENGTHS). ACCORDING TO THE NURSE, THE CLIP APPLIER DELIVERED TO THE CLINIC HAS AN OBVIOUS DEFECT. THE DIFFERENT LENGTHS OF THE "CLIPS" OF CLIP APPLIER, WHICH PREVENTS THE CLIP FROM CLOSING CORRECTLY (THE CLIP IS DEFORMED AND DOESN'T CLOSE COMPLETELY). THE START OF WORK OF THE CLIP APPLIER IN THE "OPERBLOCK" WAS SUPPOSED TO BE ON (B)(6) 2020, BUT AFTER (IN THAT DATE) PROBLEM WAS IDENTIFIED. SENIOR OPERATING NURSE, WHO HAD BEEN EXTENSIVE EXPERIENCE WORKING WITH A SIMILAR MEDICAL PRODUCT EARLIER, POINTED THE ABOVE DEFECT AND PERFORMED A CONTROL CHECK OF THE QUALITY OF THIS MEDICAL DEVICE (QUALITY OF CLOSURE THE CLIPS) BEFORE GIVING THE INSTRUMENT TO THE SURGEON. THERE WAS NO OPERATION, NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10094559 ↗
• MalfunctionDec 11, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING A PEDIATRIC THORACIC PROCEDURE, THE SURGEON DID AN ECHOCARDIOGRAM AND FOUND THAT THE CLIP WAS SCISSORED WHERE HE HAD APPLIED IT. ACCORDING TO THE CUSTOMER THE CLIP DID WHAT IS WAS SUPPOSED TO DO AND THERE WERE NO PATIENT CONSEQUENCES, BUT THE SURGEON NOTICED THAT IS WAS SCISSORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9454823 ↗
• MalfunctionJun 13, 2019Corroded; Failure to Align; Failure to Form Staple

  IT WAS REPORTED THAT THE CLIP APPLIER PRESENTED WITH OXIDIZED RINGS AND BAD CLIP FORMATION DUE TO THE MISALIGNED JAWS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696796 ↗
• MalfunctionJun 13, 2019Failure to Align; Failure to Form Staple

  IT WAS REPORTED THAT THE CLIP APPLIER PRESENTED WITH OXIDIZED RINGS AND BAD CLIP FORMATION DUE TO THE MISALIGNED JAWS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696739 ↗
• MalfunctionMay 6, 2019Failure to Align

  IT WAS REPORTED THAT DURING A CABG, THE QUALITY ISSUE PRESENTED WAS MISALIGNMENT IN THE JAWS OF THE DEVICE, CAUSING CLIPS MALFORMATION, DETACHING FROM THE PATIENT¿S TISSUE. THERE WERE NO CONSEQUENCES TO THE PATIENT. IT WAS NECESSARY TO USE ANOTHER DEVICE TO CONTINUE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8581971 ↗
• MalfunctionApr 10, 2019Failure to Align; Device Fell

  IT WAS REPORTED THAT THE JAWS OF THE CLIP APPLIERS ARE MISALIGNED, RESULTING IN THE CLIPS FALLING OUT OF THE JAWS OF THE INSTRUMENT DURING USE OR NOT LOCKING ON TISSUE DURING USE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500193 ↗
• MalfunctionJan 18, 2019Failure to Form Staple

  IT WAS REPORTED THAT THE CLIP APPLIER IS NOT HOLDING THE CLIPS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8262014 ↗
• MalfunctionJan 18, 2019Failure to Form Staple

  IT WAS REPORTED THAT THE CLIP APPLIER IS NOT HOLDING THE CLIPS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261995 ↗