LIGACLIP LX105Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20705036012846), received between Jan 9, 2018 and Mar 20, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 18941572 ↗
• MalfunctionOct 27, 2022Appropriate Device Problem Term/Code Not Available; Firing Problem; Appropriate Device Problem Term/Code Not Available; Firing Problem

  IT WAS REPORTED THAT DURING CORONARY ARTERY BYPASS GRAFT, CLIPS WERE MOVING TO THE PROXIMAL SIDE DURING APPLICATION ON ARTERY OR VEIN. CLIPS ARE NOT GETTING APPLIED ON ARTERY OR VEIN AND SOMETIMES CAUSE TRAUMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679899 ↗
• MalfunctionOct 27, 2022Appropriate Device Problem Term/Code Not Available; Firing Problem; Appropriate Device Problem Term/Code Not Available; Firing Problem

  IT WAS REPORTED THAT DURING CORONARY ARTERY BYPASS GRAFT, CLIPS WERE MOVING TO THE PROXIMAL SIDE DURING APPLICATION ON ARTERY OR VEIN. CLIPS ARE NOT GETTING APPLIED ON ARTERY OR VEIN AND SOMETIMES CAUSE TRAUMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679882 ↗
• MalfunctionOct 27, 2022Appropriate Device Problem Term/Code Not Available; Firing Problem; Appropriate Device Problem Term/Code Not Available; Firing Problem

  IT WAS REPORTED THAT DURING CORONARY ARTERY BYPASS GRAFT, CLIPS WERE MOVING TO THE PROXIMAL SIDE DURING APPLICATION ON ARTERY OR VEIN. CLIPS ARE NOT GETTING APPLIED ON ARTERY OR VEIN AND SOMETIMES CAUSE TRAUMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679837 ↗
• MalfunctionJun 9, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIPPER DOES NOT FULLY CLOSE THE CLIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14647300 ↗
• 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 8696847 ↗
• 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 8696838 ↗
• 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 8696766 ↗
• MalfunctionMay 6, 2019Material Deformation

  IT WAS REPORTED THAT DURING CHECKING THE CLIP APPLIER IT WAS FOUND THAT THE TIPS (THAT SQUEEZE THE CLIPS) WEREN¿T MEETING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583290 ↗
• MalfunctionMay 6, 2019Mechanical Problem

  IT WAS REPORTED THAT THE CLIP APPLIER WAS BEYOND REPAIR. IT WAS IDENTIFIED IN SPD. CLIP APPLIER WOULD NO LONGER HOLD CLIPS CONSISTENTLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8582308 ↗
• 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 8500339 ↗
• 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 8500165 ↗
• MalfunctionMar 6, 2018Crack; Failure to Form Staple

  QUALITY ISSUE, TIPS DON¿T MEET, CRACKED COATING ON HANDLES AND WON¿T HOLD CLIP. PROCEDURE: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7318257 ↗
• MalfunctionJan 9, 2018Failure to Align

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAWS OF THE DEVICE BECAME MISALIGNED. A ALTERNATE LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7176934 ↗