LIGACLIP LC310Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 20705036012662), received between May 9, 2018 and Oct 26, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 18011620 ↗
• 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 11033480 ↗
• 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 11033383 ↗
• 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 11033302 ↗
• 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 11033278 ↗
• MalfunctionMay 12, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS THAT WERE LOADED INTO LC310 FELL OUT OF THE CLIP APPLIER JAWS BEFORE SURGEON APPROACHED VESSEL FOR LIGATION. CLIPS WERE FOUND TO SCISSOR / BE MISALIGNED WHEN APPLIED USING THESE APPLIERS. THERE WAS NO DELAY TO PROCEDURE AND SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE EVENT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10049968 ↗
• MalfunctionMay 12, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS THAT WERE LOADED INTO LC310 FELL OUT OF THE CLIP APPLIER JAWS BEFORE SURGEON APPROACHED VESSEL FOR LIGATION. CLIPS WERE FOUND TO SCISSOR / BE MISALIGNED WHEN APPLIED USING THESE APPLIERS. THERE WAS NO DELAY TO PROCEDURE AND SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE EVENT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10049958 ↗
• 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 8696639 ↗
• MalfunctionMay 16, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CLIPS WERE FALLING OUT OF THE JAWS OF THE CLIP APPLIER WHEN THE CLIP WAS APPLIED TO THE TISSUE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615310 ↗
• MalfunctionMay 15, 2019Device Fell

  IT WAS REPORTED THAT THE CLIPS WERE FALLING OUT OF THE JAWS OF THE CLIP APPLIER WHEN THE CLIP WAS APPLIED TO THE TISSUE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8612016 ↗
• MalfunctionApr 17, 2019Peeled/Delaminated

  IT WAS REPORTED THAT THE DEVICE HAS THE COATING CHIPPING OFF AND HAVE BURS. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8523983 ↗
• MalfunctionNov 7, 2018Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN RECEIVED NEW PRODUCT REF LC310 IN THE ENGLISH DESCRIPTION ON THE PACKAGE THE LENGTH WAS 27, 5 UM, BUT IN THE (B)(4) DESCRIPTION ON THE PACKAGE THE LENGTH WAS 26, 7 UM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047589 ↗
• MalfunctionMay 9, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIP MALFORMATION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7498493 ↗