LIGACLIP LT400Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705036012832), received between Jun 28, 2018 and Dec 4, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025No 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 A VASCULAR PROCEDURE, CUTTING THE VESSEL RESULTED IN BLEEDING INSTEAD OF CLAMPING. NO FURTHER INFORMATION PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 23716076 ↗
• MalfunctionFeb 28, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING INVENTORY IT WAS NOTICED THAT THERE WAS A PERFORATION IN DEVICES SECONDARY PACKAGING. DEVICE NOT USED IN PROCEDURE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797635 ↗
• InjuryJul 11, 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 POST OP TO A CHOLANGIOGRAPHY BY VIDEO LAPAROSCOPY, THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN, DISTENSION, NAUSEA AND VOMITING. THE PATIENT UNDERWENT A CT SCAN OF THE ABDOMEN AND IT WAS DISCOVERED THAT THERE WAS A SMALL AMOUNT OF FLUID IN THE ABDOMINAL CAVITY AND NOTABLY IN THE PELVIC REGION, AS WELL AS OBLITERATION OF ADJACENT FAT, RELATED TO PREVIOUS MANIPULATION. THERE WAS A NEED FOR SURGICAL RE-APPROACH, WHICH WAS IDENTIFIED THAT THE CLIP WAS OPEN.

  Patient problems: Abdominal Distention; Failure to Anastomose; Nausea; Pain; Vomiting

  MAUDE report 17302454 ↗
• MalfunctionSep 23, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT POST OP TO A LAPAROSCOPIC CHOLECYSTECTOMY THE PATIENT WAS FOUND TO HAVE 3,000 ML OF BLOOD IN THE ABDOMEN. THE PATIENT WAS REOPERATED ON AND IT WAS DISCOVERED THE CLIPS DID NOT CLOSE IN THE MIDDLE. THIS WAS CORRECTED AND FOUR UNITS OF BLOOD WERE GIVEN AND THE PATIENT IS IMPROVING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15474083 ↗
• InjuryJul 18, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT WITH ACUTE PANCREATITIS, HOSPITALIZED ON (B)(6) 2019, UNDERWENT LAPAROSCOPIC SURGERY CONVERTED TO LAPAROTOMY WITH BILEODIGESTIVE DERIVATION (HEPATICOJEJUNOSTOMY IN Y-DE-ROUX). CLIPS APPLIED IN THE LIGATION OF THE BILIARY TRACT WERE LOOSEN. PREOPERATIVE DIAGNOSIS: BILIARY FISTULA. POSTOPERATIVE DIAGNOSIS: LOOSENING OF THE CYSTIC DUCT LIGATURE + PARTIAL ISCHEMIA OF THE COLÉDOCO AND HEPATIC DUCT. INTERCURRENT: CONVERSION TO OPEN SURGERY. DESCRIPTION OF THE SURGERY: PATIENT IN DORSAL DECUBITUS UNDER GENERAL ANESTHESIA. ANTISEPSIS AND PLACEMENT OF STERILE FIELDS. WITHDRAWAL OF THE STITCHES OF THE PREVIOUS SURGERY AND PNEUMOPERITONEUM DONE BY THE UMBILICAL INCISION BY OPEN TECHNIQUE. CAVITY REVIEW: SMALL AMOUNT OF FREE BILIARY SECRETION IN HYPOCHONDRIUM D, INTENSE INFLAMMATORY BLOCK IN HCD. THE BLOCKAGE WAS DISASSEMBLED WITH EXTREME CAUTION WITH VISUALIZATION OF LOOSENING OF THE CYSTIC LIGATION CLIP, PARTIAL ISCHEMIA OF THE COMMON BILE DUCT AND HEPATIC DUCT APPROXIMATELY 20 MM PROXIMAL AND DISTAL TO THE LOCAL OF THE LOOSEN CLIP, INTENSE LOCAL INFLAMMATORY PROCESS. DUE TO THE IMPOSSIBILITY OF CONTINUING THE PROCEDURE BY LAPAROSCOPY, IT WAS DECIDED TO CONVERT T

  Patient problems: Failure to Anastomose; Fistula; Ischemia; No Code Available

  MAUDE report 8804490 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: MID-TERM OUTCOMES OF PATIENTS UNDERGOING ADJUSTABLE PULMONARY ARTERY BANDING AUTHORS: SACHIN TALWAR, NEERAJ ARAVIND KAMAT, SHIV KUMAR CHOUDHARY, SIVASUBRAMANIAN RAMAKRISHNAN, ANITA SAXENA, RAJNISH JUNEJA, SHYAM SUNDER KOTHARI, AND BALRAM AIRAN CITATION: I N D I A N H E A R T J O U R N A L 6 8 ( 2 0 1 6 ) 7 2 ¿ 7 6, HTTP://DX.DOI.ORG/10.1016/J.IHJ.2015.06.036. THE AIM OF THIS STUDY WAS TO ANALYZE THE OUTCOMES OF APAB IN THE MID-TERM IN TERMS OF THE REDUCTION OF PA PRESSURES AND SUITABILITY FOR DEFINITIVE PALLIATION AND TO STUDY THE BAND RELATED COMPLICATIONS ENCOUNTERED AT DEFINITIVE SURGERY. BETWEEN JANUARY 2002 UNTIL DECEMBER 2002, 73 PATIENTS UNDERWENT ADJUSTABLE PULMONARY ARTERY BAND (APAB) WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, THE MPA WAS LOOPED WITH A NO. 2 ETHIBOND (JOHNSON AND JOHNSON INC, SOMERVILLE, NJ) SUTURE AFTER PASSING A RIGHT-ANGLE FORCEPS BETWEEN THE AORTA AND THE MPA. BOTH ARMS OF THE SUTURE WERE CLIPPED TOGETHER WITH A LIGACLIP (LT 200; ETHICON ENDOSURGERY INC, CINCINNATI, OH) JUST ON THE PLEDGET. THESE SUTURES WERE BROUGHT OUT THROUGH THE PERICARDIUM AND THE LATERAL EDGE OF THE STERNUM AND THEN THROUGH SUBCU

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7869127 ↗
• MalfunctionJul 9, 2018Difficult to Open or Close

  THE CLIPS DO NOT CLOSE PROPERLY WITH CONSEQUENT ISSUE FOR THE HEMOSTASIS. PROCEDURE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669251 ↗
• MalfunctionJun 28, 2018Detachment of Device or Device Component

  AFTER THE APPLICATION THE CLIP DETACHED. THE ISSUE WAS SOLVED USING NEW ONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7646936 ↗

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-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
• 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