LIGACLIP LX107Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 20705036012853), received between Mar 9, 2018 and Sep 16, 2026 — classified as 2 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (55 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 105 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 50788300 ↗
• MalfunctionJul 6, 2026Failure to Form Staple

  IT WAS REPORTED THAT A CLIP APPLIER IS SCISSORING DURING CABG PROCEDURE. NO ADVERSE IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25716871 ↗
• MalfunctionJun 15, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE, CLIP APPLIERS ARE SCISSORING DURING CASES. THERE IS NO PATIENT HARM THAT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505608 ↗
• MalfunctionMay 29, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, IT WAS UNCLEAR WHETHER THE ISSUE OCCURRED PRIOR TO OR DURING THE PROCEDURE. THE FIRST DEVICE WAS REPORTED TO HAVE A TIP DEFECT, AND THE SECOND DEVICE WOULD NOT OPEN. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25335509 ↗
• MalfunctionMay 22, 2026Failure to Form Staple

  IT WAS REPORTED TO THE SALES REP THAT DURING A CABG PROCEDURE, THE SURGEON REPORTED SCISSORING WHEN ATTEMPTING TO APPLY CLIPS. WHEN CLIPPING DIRECTLY ON THE TISSUE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256213 ↗
• MalfunctionMay 22, 2026Failure to Form Staple

  IT WAS REPORTED TO THE SALES REP THAT DURING A CABG PROCEDURE, THE SURGEON REPORTED SCISSORING WHEN ATTEMPTING TO APPLY CLIPS. WHEN CLIPPING DIRECTLY ON THE TISSUE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256194 ↗
• MalfunctionMay 19, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE, CLIP APPLIERS ARE SCISSORING DURING CASES. THERE IS NO PATIENT HARM THAT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218353 ↗
• MalfunctionMay 14, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE CLIP APPLIERS ARE SCISSORING DURING CASES. THERE IS NO PATIENT HARM THAT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174889 ↗
• MalfunctionMay 14, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE, CLIP APPLIERS ARE SCISSORING DURING CASES. THERE IS NO PATIENT HARM THAT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174869 ↗
• 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 24305465 ↗
• 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 24305396 ↗
• MalfunctionJan 14, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THAT ON THREE DEVICES, THE SURGEON EXPERIENCED A SCISSORING ISSUE WITH THE CLIP APPLIER. WHEN THE DEVICE WAS CLOSED, THE RIDGE SEEMS OFF. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068054 ↗
• MalfunctionJan 14, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THAT ON THREE DEVICES, THE SURGEON EXPERIENCED A SCISSORING ISSUE WITH THE CLIP APPLIER. WHEN THE DEVICE WAS CLOSED, THE RIDGE SEEMS OFF. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068032 ↗
• MalfunctionJan 14, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THAT ON THREE DEVICES, THE SURGEON EXPERIENCED A SCISSORING ISSUE WITH THE CLIP APPLIER. WHEN THE DEVICE WAS CLOSED, THE RIDGE SEEMS OFF. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067981 ↗
• MalfunctionJun 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A THYROIDECTOMY SURGERY. AFTER CLAMPED THE CLIPS AND CLIP COULD NOT CLOSE. CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED, NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178980 ↗
• MalfunctionMar 19, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DEVICE BECOMES DISTORTED AND DOES NOT FULFILL ITS FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647222 ↗
• MalfunctionMar 4, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP IS NOT PERFORMING CORRECTLY. THERE WERE NO PATIENT CONSEQUENCE REPORTED. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518038 ↗
• 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 20725331 ↗
• MalfunctionOct 24, 2024No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP APPLIER IS CUTTING THE TISSUE WHEN THE JAW IS CLOSED, WHICH IS CAUSING LEAKAGE AND BLEEDING. PROCEDURE DELAYED 20 MINUTES. A NEW CLIP APPLIER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529859 ↗
• MalfunctionJul 17, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WOULD NOT BECOME SECURE AND WOULD SLIP OFF. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763638 ↗
• MalfunctionJul 17, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WOULD NOT BECOME SECURE AND WOULD SLIP OFF. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763606 ↗
• InjuryApr 17, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CABG PROCEDURE THAT THE CLIPS ARE EITHER SCISSORING OR FALLING OUT OF THE APPLIER BEFORE THEY CAN BE APPLIED. POST OP OF THE PROCEDURE, PATIENT DEVELOPED A BLEED WHICH WAS NOTICED BY THEIR HEMOGLOBIN DROPPING. PATIENT WAS BROUGHT BACK TO THE OR AND CLIPPED THE BLEEDING VESSEL WHICH HAD PREVIOUSLY RECEIVED A SCISSORED CLIP. PATIENT DOING FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19125237 ↗
• MalfunctionApr 11, 2024Unintended Ejection; Failure to Form Staple; Unintended Ejection; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS ARE NOT CLIPPING PROPERLY AND ARE NOT EFFECTIVE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091794 ↗
• MalfunctionMar 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS ARE NOT CAPTURING PROPERLY ON THE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941540 ↗
• MalfunctionMar 7, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A MYOCARDIAL REVASCULARIZATION WITH BYPASS PROCEDURE, DEVICE DOES NOT COMPLETE THE NECESSARY ADJUSTMENT OF CLIPS. THE CLIP DOES NOT PROPERLY GRASP THE VESSEL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857137 ↗