SINGLE USE LIGATING DEVICE HX-400U-30 (REF N5382130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 239 adverse event reports that list this exact device (DI 04953170368615), received between Jul 16, 2018 and Sep 16, 2026 — classified as 120 injuries, 119 malfunctions.

The most frequently reported specific device problem is “Break” (75 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Oct 30, 2025Open, Classified

   Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

   Z-0570-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 239 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break; Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797005 ↗
• InjurySep 10, 2026Break; Detachment of Device or Device Component

  It was reported that during a therapeutic double balloon antegrade enterostomy, the Single use ligating device while being deployed inside the patient the wire snapped. As a result, the patient was taken for additional procedure into operation theater for Minilaparotomy, enterotomy, excision of polyp and release of entrapped detachable snare. The patient was operated and reported to be discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718473 ↗
• MalfunctionAug 28, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501085 ↗
• MalfunctionAug 17, 2026Separation Failure; Difficult to Open or Close; Mechanical Jam

  No additional information received from the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279389 ↗
• MalfunctionAug 12, 2026Fracture; Difficult to Remove; Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222543 ↗
• MalfunctionJul 10, 2026Difficult or Delayed Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783432 ↗
• MalfunctionMay 15, 2026Difficult or Delayed Separation

  IT WAS REPORTED THE SINGLE USE LIGATING DEVICE LOOP'S RING DOESN'T COME OUT. THE ISSUE OCCURRED DURING A THERAPEUTIC EMR PROCEDURE. THE PROCEDURE WAS DELAYED, HOWEVER THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25187065 ↗
• InjuryMay 12, 2026Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A COLONOSCOPY, WHILE PERFORMING A POLYPECTOMY, THE LOOP OF THE LIGATING DEVICE WAS UNABLE TO DETACH, AND THE CANNULA/DEPLOYMENT DEVICE WAS UNABLE TO BE WITHDRAWN AFTER THE DEVICE WAS DEPLOYED. THE SLIDER LOCATED ON THE DEVICE HANDLE COULD NOT MOVE FORWARD OR BACKWARD. THE OPERATING WIRE HAD TO BE CUT TO REMOVE THE DEVICE FROM THE PATIENT/SCOPE. THE HOT SNARE WAS REQUIRED TO REMOVE THE STUCK POLYP LOOP. THE SCOPE WAS REMOVED AND REINSERTED. AN ENDOSCOPIC SUBMUCOSAL DISSECTION WAS PERFORMED TO COMPLETE THE PROCEDURE. IN ADDITION, IT WAS REPORTED THAT THE LESION WAS A 30 MM PEDUNCULATED POLYP ON A STALK LOCATED IN THE SIGMOID COLON. THE PROCEDURE WAS DELAYED FOR ABOUT 75 MINUTES, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA WITH PROPOFOL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION DUE TO THE LENGTH OF THE PROCEDURE TIME AND EXTENSIVE POLYPECTOMY TO ENSURE NO BLEEDING. THE PATIENT WAS DISCHARGED IN STABLE CONDITION. THIS REPORT IS 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156699 ↗
• InjuryMay 12, 2026Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A COLONOSCOPY, WHILE PERFORMING A POLYPECTOMY, THE LOOP OF THE LIGATING DEVICE WAS UNABLE TO DETACH, AND THE CANNULA/DEPLOYMENT DEVICE WAS UNABLE TO BE WITHDRAWN AFTER THE DEVICE WAS DEPLOYED. THE SLIDER LOCATED ON THE DEVICE HANDLE COULD NOT MOVE FORWARD OR BACKWARD. THE OPERATING WIRE HAD TO BE CUT TO REMOVE THE DEVICE FROM THE PATIENT/SCOPE. THE HOT SNARE WAS REQUIRED TO REMOVE THE STUCK POLYP LOOP. THE SCOPE WAS REMOVED AND REINSERTED. AN ENDOSCOPIC SUBMUCOSAL DISSECTION WAS PERFORMED TO COMPLETE THE PROCEDURE. IN ADDITION, IT WAS REPORTED THAT THE LESION WAS A 30 MM PEDUNCULATED POLYP ON A STALK LOCATED IN THE SIGMOID COLON. THE PROCEDURE WAS DELAYED FOR ABOUT 75 MINUTES, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA WITH PROPOFOL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION DUE TO THE LENGTH OF THE PROCEDURE TIME AND EXTENSIVE POLYPECTOMY TO ENSURE NO BLEEDING. THE PATIENT WAS DISCHARGED IN STABLE CONDITION. THIS REPORT IS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156685 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THE SINGLE USE LIGATING DEVICE'S CABLE BROKE, DISALLOWING RELEASE WHILST TIGHTENED AROUND A LESION. THIS OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095462 ↗
• MalfunctionMay 1, 2026Material Deformation; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THE SINGLE USE LIGATING DEVICE DID NOT DEPLOY FROM DELIVERY SYSTEM ONCE PLACED ONTO POLYP. THE ISSUE OCCURRED DURING A THERAPEUTIC COLON POLYPECTOMY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056438 ↗
• MalfunctionApr 20, 2026Difficult or Delayed Separation

  NO NEW ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925110 ↗
• InjuryApr 13, 2026Entrapment of Device; Difficult to Remove; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, THE SINGLE USE LIGATING DEVICE MAY NOT HAVE BEEN DEPLOYED CORRECTLY. UPON FURTHER FOLLOW UP, THE CUSTOMER INDICATED THAT THE DEVICE ANCHORED ITSELF AROUND THE PATIENT'S TISSUE. THE PROCEDURALIST COULD NOT REMOVE IT FOR A PROLONGED PERIOD BECAUSE THE SLIDER PART OF THE DEVICE DETACHED FROM THE OPERATION WIRE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH A DELAY GREATER THAN OR EQUAL TO 30 MINUTES. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857501 ↗
• InjuryApr 13, 2026Entrapment of Device; Difficult to Remove; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, THE SINGLE USE LIGATING DEVICE MAY NOT HAVE BEEN DEPLOYED CORRECTLY. UPON FURTHER FOLLOW UP, THE CUSTOMER INDICATED THAT THE DEVICE ANCHORED ITSELF AROUND THE PATIENT'S TISSUE. THE PROCEDURALIST COULD NOT REMOVE IT FOR A PROLONGED PERIOD BECAUSE THE SLIDER PART OF THE DEVICE DETACHED FROM THE OPERATION WIRE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH A DELAY GREATER THAN OR EQUAL TO 30 MINUTES. THERE WERE NO REPORTS OF FURTHER PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED INCLUDING FURTHER PATIENT DETAILS, OUTCOME, AND METHOD OF DEVICE REMOVAL, BUT NO CUSTOMER RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857457 ↗
• InjuryApr 6, 2026Material Twisted/Bent; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A THERAPEUTIC POLYPECTOMY, THE SINGLE USE LIGATING DEVICE FAILED TO DEPLOY. WHILE ATTEMPTING TO ATTACH AND CLOSE THE LOOP AROUND THE POLYP, THE DEVICE GOT STUCK RESULTING IN FAILURE TO RELEASE THE LOOP. THE CATHETER HAD TO BE CUT ON THE HANDLE END OF THE DEVICE AND THE SCOPE WAS REMOVED. THE SCOPE WAS THEN REINSERTED, AND THE LOOP WAS REMOVED USING A LOOP CUTTER. UPON INSPECTION AFTER THE PROCEDURE, IT WAS NOTED THAT THE WIRE ON THE CATHETER HANDLE WAS BENT IN A Z SHAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796019 ↗
• MalfunctionMar 20, 2026Physical Resistance/Sticking

  IT WAS REPORTED THE SINGLE USE LIGATING DEVICE SLIDER PRESENTED SOME RESISTANCE DURING USE, HOWEVER DEVICE DEPLOYED AND PRODUCT USE WAS SUCCESSFUL. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651416 ↗
• MalfunctionMar 11, 2026No Apparent Adverse Event

  IT WAS REPORTED THE SINGLE-USE LIGATING DEVICE'S DETATCHABLE LOOP WAS LOOSENING DURING A POLYPECTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569776 ↗
• InjuryMar 7, 2026Difficult to Remove; Separation Failure

  IT WAS REPORTED THAT DURING A THERAPEUTIC PROCEDURE UNDER SEDATION, THE SINGLE USE LIGATURE COULD NOT BE RELEASED. THE LIGATURE WAS CUT AND REMOVED. NO REPORTS OF ADVERSE PATIENT HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539909 ↗
• InjuryFeb 20, 2026Difficult or Delayed Separation

  IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE THE SINGLE USE LIGATING DEVICE FAILED. AFTER ATTEMPTING DEPLOYMENT OF THE SINGLE USE LIGATING DEVICE, THE MECHANISM WOULD NOT RELEASE RESULTING IN THE WIRE NEEDING TO BE CUT TO REMOVE FROM THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405940 ↗
• InjuryFeb 10, 2026Difficult or Delayed Separation

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308645 ↗
• InjuryFeb 2, 2026Difficult or Delayed Separation

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236069 ↗
• MalfunctionJan 23, 2026Difficult to Open or Close

  IT WAS REPORTED THE SINGLE USE LIGATING DEVICE POLYLOOP WAS DEFECTIVE WHEREIN THE POLYLOOP YELLOW SLIDER WAS NOT SLIDING PROPERLY TO CLOSE LOOP SEEMED TO GET STUCK ON SHEATH. THE ISSUE OCCURRED DURING AND UNKNOWN COLONOSCOPY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163144 ↗
• MalfunctionJan 23, 2026Difficult to Open or Close

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163087 ↗
• InjuryJan 15, 2026Firing Problem; Premature Separation

  THIS IS REPORT 1 OF 2: IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS AN ATTEMPT TO USE A LIGATING DEVICE. THE LIGATING DEVICE WAS PREMATURELY DEPLOYED AND FELL OUT OF THE LESION. THERE AS AN ATTEMPT TO RETRIEVE THE LOOP WITH FORCEPS THROUGH THE INSTRUMENT CHANNEL OF THE SCOPE BUT NOTHING WAS FOUND AND THE PROCEDURE WAS CLOSED. THE SCOPE WAS REPROCESSED AS USUAL. A FEW DAYS LATER, AFTER A CASE, WITH NO REPORTED ISSUES OF THE SCOPE, DURING REPROCESSING, THE LOOP DROPPED OUT OF THE INSTRUMENT CHANNEL AND DISPOSED OF. LEAKAGE TESTING WAS CONDUCTED AND NO ISSUE TO BE FOUND. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082993 ↗
• InjuryJan 9, 2026Difficult or Delayed Separation

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021262 ↗