LIGACLIP LT300Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10705036012825), received between Feb 15, 2018 and Sep 23, 2026 — classified as 14 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (21 reports).

3 other recalls cover devices cleared under the same FDA submission (K830503); they may or may not involve this specific model.

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 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  Patient problems: Insufficient Information

  MAUDE report 50873078 ↗
• MalfunctionSep 15, 2026Failure to Form Staple

  It was reported that during an Unknown surgery. After clamped the clips and clip could not close. Changed another one to complete the procedure. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777854 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  It was during an unknown procedure when the surgeon was using our clips, Surgeon used these clips in ARS hospital performing gallbladder surgery. He was using clips with Wolf clip applier and it was difficult to apply these clips but somehow he put them to the needed structure. Unfortunately patient had post op. bleeding because clip fall down and emergency surgery was done in the an other hospital. The patient's condition is serious.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50733079 ↗
• MalfunctionFeb 19, 2026No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE HEMOLOCK AND METAL CLIP PLACED ON THE KIDNEY ARTERY IN A LIVING DONOR PATIENT. CLIP THAT SLIPPED ON 3 CLIPS ONLY ONE REMAINS. HEMOCLIP WAS THE SUBJECT OF ANOTHER MATERIOVIGILANCE STATEMENT (B)(6). HAEMORRHAGIC AND VITAL RISK+++, CONTROLLED HEMORRHAGE, RESUMPTION WITH THREAD SUTURE.

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

  MAUDE report 24394191 ↗
• MalfunctionFeb 10, 2026No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CYSTIC DUCT AND CYSTIC ARTERY WERE LIGATED WITH LIGA-CLIP LT 300 CLIPS; THEY WERE SECURELY APPLIED AND CHECKED TO ENSURE THEY WERE WELL CLOSED. SUBSEQUENTLY, ON INSPECTING THE CAVITY, CLIPS WERE FOUND TO BE COMPLETELY LOOSE, WITH ACTIVE ARTERIAL BLEEDING AND BILE LEAKAGE FROM THE CYSTIC DUCT; THE STRUCTURES WERE URGENTLY LIGATED WITH PURPLE HEM-O-LOK CLIPS. NO PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 24306076 ↗
• MalfunctionFeb 10, 2026No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CYSTIC DUCT AND CYSTIC ARTERY WERE LIGATED WITH LIGA-CLIP LT 300 CLIPS; THEY WERE SECURELY APPLIED AND CHECKED TO ENSURE THEY WERE WELL CLOSED. SUBSEQUENTLY, ON INSPECTING THE CAVITY, CLIPS WERE FOUND TO BE COMPLETELY LOOSE, WITH ACTIVE ARTERIAL BLEEDING AND BILE LEAKAGE FROM THE CYSTIC DUCT; THE STRUCTURES WERE URGENTLY LIGATED WITH PURPLE HEM-O-LOK CLIPS. NO PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 24306052 ↗
• MalfunctionOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GLOBAL BRAND PROTECTION LATAM TEAM HAS CONDUCTED A TEST PURCHASE IN PERU FROM TWO UNAUTHORIZED AND SUSPICIOUS SELLERS. THE DETAILS OF ALL PURCHASED PRODUCTS ARE LISTED BELOW. PLEASE INITIATE A PRODUCT COMPLAINT TO DOCUMENT THE TEST PURCHASE, AND THOROUGHLY CHECK THE PRODUCTS, BATCHES, AND EXPIRY DATES TO VERIFY POTENTIAL COUNTERFEIT OR DIVERSION. THE BATCH WAS NOT FOUND IN THE J&J SYSTEM, AS SHOWN IN THE ATTACHED FILE. CONFIRMATION OF THIS INFORMATION IS REQUIRED TO QA TEAM. THERE ARE SIGNS OF POTENTIAL COUNTERFEITING, INCLUDING TYPOS, WHICH RAISE SUSPICION OF COUNTERFEIT ELEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300893 ↗
• MalfunctionOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GLOBAL BRAND PROTECTION LATAM TEAM HAS CONDUCTED A TEST PURCHASE IN PERU FROM TWO UNAUTHORIZED AND SUSPICIOUS SELLERS. THE DETAILS OF ALL PURCHASED PRODUCTS ARE LISTED BELOW. PLEASE INITIATE A PRODUCT COMPLAINT TO DOCUMENT THE TEST PURCHASE, AND THOROUGHLY CHECK THE PRODUCTS, BATCHES, AND EXPIRY DATES TO VERIFY POTENTIAL COUNTERFEIT OR DIVERSION. THE BATCH WAS NOT FOUND IN THE J&J SYSTEM, AS SHOWN IN THE ATTACHED FILE. CONFIRMATION OF THIS INFORMATION IS REQUIRED TO QA TEAM. THERE ARE SIGNS OF POTENTIAL COUNTERFEITING, INCLUDING TYPOS, WHICH RAISE SUSPICION OF COUNTERFEIT ELEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299683 ↗
• InjuryAug 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AND UNKNOWN PROCEDURE, A MULTIPLE CLIP APPLIER AND CLIPS WERE USED, IN WHICH 5 CLIPS WERE LEFT IN THE INCISION AS A MARKER FOR POSTOPERATIVE RADIOTHERAPY. AFTER THE OPERATION, THE METAL FOREIGN BODY WAS REPEATEDLY DISCHARGED FROM THE INCISION, AND 4 TITANIUM CLIPS HAVE BEEN DISCHARGED SO FAR. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22803470 ↗
• MalfunctionMar 25, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WERE CLOSING WRONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688857 ↗
• MalfunctionMar 25, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, QUALITY DEVIATION IN THE CLIP. THEY ARE CLOSING WRONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688434 ↗
• MalfunctionJan 9, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE, DEVICE DOES NOT CLOSE PROPERLY, REQUIRING EXCESSIVE FORCE TO DO IT. PROCEDURE DELAYED 30 MINUTES. PROCEDURE COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117841 ↗
• MalfunctionDec 11, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NON-COMPLIANCE WITH THE LABELING, REGULATORY AND TECHNICAL DOCUMENTATION WAS ESTABLISHED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906246 ↗
• MalfunctionSep 24, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIPS WERE VERY LOOSE IN THE APPLIER AND THE SURGEON HAD ONE THAT FELL OFF IN A PATIENT (THEY FOUND IT) PLUS THEY DID NOT SEAL AROUND THEY DUCT VERY WELL. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292329 ↗
• MalfunctionJun 18, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP DOES NOT CLOSE COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558609 ↗
• MalfunctionJun 11, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A GALLBLADDER PROCEDURE, THE CLIP DOES NOT CLOSE COMPLETELY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512917 ↗
• MalfunctionApr 9, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP CAME OPEN AND IT WAS NOT POSSIBLE TO CLIP, AS THE CLIP DID NOT CLOSE PROPERLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070786 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE BY VIDEOLAPAROSCOPY, A PROCEDURE THAT OCCURRED WITHOUT COMPLICATIONS. ON THE FOLLOWING DAY, PATIENT PRESENTED WITH DISTENSION AND ABDOMINAL PAIN, GASES, VOMITING AND DYSPNEA, WITH PROGRESSIVE WORSENING IN SUBSEQUENT DAYS, REQUIRING HOSPITALIZATION IN THE ICU WITH A DIAGNOSTIC HYPOTHESIS OF ABDOMINAL SEPSIS. PATIENT SUBMITTED TO LAPAROSCOPY DIAGNOSES,4 DAYS AFTER FIRST SURGICAL PROCEDURE. BILE EXTRAVASATION IDENTIFIED IN THE HEPATIC PEDICLE REGION, VERIFIED CYSTIC DUCT WITH IMPORTANT ESCAPE OF BILE BY DETACHMENT OF THE METAL CLIP USED IN THE PREVIOUS PROCEDURE.

  Patient problems: Dyspnea; Failure to Anastomose; Pain; Paresis; Sepsis; Vomiting

  MAUDE report 17347583 ↗
• InjuryJun 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY, A BILIARY LESION DUE TO INSTITUTIONAL LAPAROSCOPIC POST-OP D-CLIPS IS REPORTED. PATIENT GOES TO AN INSTITUTION WHERE A LOOSE CLIP IS EVIDENT.

  Patient problems: Insufficient Information

  MAUDE report 17080121 ↗
• MalfunctionMar 10, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP DID NOT CLOSE FULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523592 ↗
• MalfunctionFeb 22, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DEVICE WAS USED TO CLIP THE CECAL APPENDIX, BUT WHEN TIGHTENING, THE CLIP DID NOT SEAL. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418528 ↗
• MalfunctionFeb 22, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS IRREGULAR CLIPPING, NOT EFFECTIVE. CLIP DROPPING AFTER CLIPPING. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418435 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN THE IMMEDIATE POSTOPERATIVE PERIOD OF A CHOLECYSTECTOMY, FLUID WAS OBSERVED IN THE CAVITY AND THE DAY AFTER THE PROCEDURE THE PATIENT WAS TAKEN BACK TO THE SURGICAL CENTER AND IT WAS NOT POSSIBLE TO LOCATE WHERE THE BILE LEAK WAS. A DRAIN WAS PLACED AND THE PATIENT WAS KEPT IN THE ICU. AFTER A WHILE, THE PATIENT STARTED WITH HEMODYNAMIC INSTABILITY BECAUSE HE HAD CARDIOVASCULAR PROBLEMS AND DIED IN A FEW DAYS.

  Patient problems: Failure to Anastomose

  MAUDE report 15679360 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A CHOLECYSTECTOMY, REOPERATION WAS NEEDED BECAUSE OF A BILE LEAK. ERCO WAS PERFORMED AND A DRAIN WAS LEFT. PATIENT IN SERIOUS HOSPITALIZED CONDITION.

  Patient problems: Failure to Anastomose

  MAUDE report 15679255 ↗
• InjuryOct 27, 2022Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A CHOLECYSTECTOMY PROCEDURE, THE PATIENT IS IN THE ICU WITH A BILIOMA BECAUSE IT LEAKED THROUGH THE CLIP.

  Patient problems: Abdominal Distention; Discomfort; Failure to Anastomose; Inflammation; Pain

  MAUDE report 15679227 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K830503. One submission often covers many models, so check the product and lot details in each record.

• Z-1776-2013 · Apr 12, 2013 · Terminated
  LIGACLIP Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, sing
• Z-1777-2013 · Apr 12, 2013 · Terminated
  LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient us
• Z-1775-2013 · Apr 12, 2013 · Terminated
  LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instru