SINGLE USE LIGATING DEVICERecalls & reported problems across all models

We found 2 models of SINGLE USE LIGATING DEVICE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 336 adverse event reports in the FDA's MAUDE database, received between May 13, 2018 and Sep 18, 2026 — classified as 178 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Break” (102 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SINGLE USE LIGATING DEVICE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 SINGLE USE LIGATING DEVICE problems

SINGLE USE LIGATING DEVICE models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SINGLE USE LIGATING DEVICE HX-400U-30

  Ligator, Esophageal
  1 recall239 reports
• SINGLE USE LIGATING DEVICE HX-400U-30

  Ligator, Esophageal
  97 reports

Recent SINGLE USE LIGATING DEVICE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Separation Failure

  The customer reported that a Single Use Ligating Device malfunctioned during a therapeutic polypectomy performed during a colonoscopy. The patient was sedated, and the device was in use when the event occurred.A regular colonoscope was advanced to the cecum, where a large polypoid lesion/lipoma was noted in the ascending colon. The physician requested a Ligating Device to ligate the base. The ligating loop was deployed at the base of the polyp / lipoma and tightened appropriately; however, the loop failed to deploy from the sheath of device. Multiple attempts by the physician and nursing staff to deploy the loop were unsuccessful.The physician attempted to insert a pediatric colonoscope with the regular colonoscope to advance a loop cutter and free the stuck Ligating Device sheath from the regular scope; however, this attempt was unsuccessful and was abandoned. Wire cutters were then used to cut the portion of the ligating loop hanging out of the biopsy channel in an effort to detach the endoscope from the stuck Ligating Device. The colonoscope was withdrawn while biopsy forceps were advanced through the biopsy channel forcing the poly loop sheath to remain in patient while scope c

  Patient problems: Laceration(s)

  MAUDE report 50828470 ↗
• 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 ↗
• MalfunctionJun 23, 2026Difficult or Delayed Separation

  THE CUSTOMER REPORTED POLYP CUT WITH THE ENDOLOOP, DID NOT DETACH DURING AN UNSPECIFIED POLYPECTOMY OF A PEDUNCULATED POLYP WITH A WIDE AND LONG STALK INVOLVING AN OLYMPUS SINGLE USE LIGATING DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

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

  MAUDE report 25595142 ↗
• MalfunctionMay 19, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE LIGATING DEVICE HOOK WAS EXTENDED BY PUSHING THE SLIDER, THE LOOP DETACHED FROM THE HOOK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224686 ↗
• 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 ↗

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