SINGLE USE LIGATING DEVICE HX-400U-30 (UDI 04953170194641)Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 04953170194641), received between May 13, 2018 and Sep 18, 2026 — classified as 58 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (31 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, 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 The colonoscope was withdrawn while biopsy forceps were advanced through the biopsy channel forcing the poly loop sheath to remain in patient while scope c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 ↗
• 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 ↗
• MalfunctionApr 16, 2026Material Split, Cut or Torn

  IT WAS REPORTED THE SINGLE USE LIGATING DEVICE LOOP DOES NOT CLAMP BUT CUTS OFF THE POLYP. THE ISSUE OCCURRED DURING A THERAPEUTIC POLYPECTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903437 ↗
• MalfunctionSep 12, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE SINGLE USE LIGATING DEVICE'S HANDLE SPRING BROKE AND WAS EJECTED, MAKING THE LIGATION LOOP UNABLE TO BE RELEASED. THEN THE DOCTOR CUT THE OUTER SHEATH WIRE, AND THE LIGATION LOOP WAS SUCCESSFULLY RELEASED. THE ISSUE WAS FOUND DURING AN ESD (ENDOSCOPIC SUBMUCOSAL DISSECTION) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043196 ↗
• MalfunctionSep 12, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHILE USING THE LIGATING DEVICE DURING SURGICAL HEMOSTASIS, THE WIRE AT THE HANDLE BROKE AND THE FRONT END COULD NOT BE RELEASED. THE HANDLE WAS CUT OFF AND THE PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038863 ↗
• MalfunctionSep 5, 2025Failure to Eject; Failure to Eject

  IT WAS REPORTED THE SUBJECT DEVICE WAS ATTEMPTING TO DISCHARGE THE POLY LOOP TO REMOVE THE POLYP THAT WAS STILL ATTACHED TO THE DEVICE, BUT IT WAS UNABLE TO BE RELEASED FROM THE POLY LOOP DEVICE. THE ISSUE OCCURRED DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986971 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THE SINGLE USE LIGATING DEVICE'S SPRING IN THE HANDLE BROKE. THE ENDOLOOP REMAINED STUCK IN THE COLONOSCOPE, STILL ATTACHED TO THE POLYP. THE ISSUE OCCURRED DURING A POLYPECTOMY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686170 ↗
• InjuryApr 25, 2025Break; Break

  IT WAS REPORTED DURING SEDATION OF AN UNKNOWN THERAPEUTIC PROCEDURE THE METAL OF THE LOOPS HANDPIECE BROKE AND THE POLY LOOP WAS STUCK INSIDE OF THE PATIENT WHICH REQUIRE SIDE CUTTERS TO REMOVE. THERE WAS A DELAY IF APPROXIMATELY 15 MINUTES AND THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909550 ↗
• InjuryApr 17, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A COLONOSCOPY, THEY COULDN'T GET SUBJECT DEVICE OFF FROM THE HOOK. THE HANDLE PART DIDN'T WORK. THE SUBJECT DEVICE GOT STUCK INSIDE OF THE PATIENT AND NEEDED TO USE SIDE CUTTERS TO GET THE DEVICE OUT. THEY DIDN'T GET THE POLYP OUT AND THEY HAD TO SEND THE PATIENT TO THE HOSPITAL. THE PROCEDURE WAS EXTENDED BY 20 MINUTES. THE PATIENT WAS ENDOSCOPICALLY EXAMINED AT THE UNIVERSITY HOSPITAL AND REQUIRED TWO NEW ENDOSCOPIC EXAMINATIONS. THE PATIENT REQUIRED ANOTHER CHECK-UP ONE WEEK LATER TO CHECK THE CONDITION OF THE LOOP AND A NEW APPOINTMENT TO ACTUALLY REMOVE THE POLYP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858777 ↗
• InjuryMar 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE HANDLE PART BROKE, THE SPRING FLEW OFF AND THE DEVICE GOT STUCK INSIDE THE PATIENT. THEY HAD TO CUT THE WIRE WITH SIDE CUTTERS AND TOOK THE ENDOSCOPE OUT WITH THE DEVICE SHEATH. THERE WERE DIFFICULTIES TO CUT THE DEVICE OUT THE PATIENT AND THEY USED ANOTHER DEVICE THAT DIDN'T WORK. THEY EVENTUALLY USED A HOT SNARE TO CUT THE DEVICE OUT THE PATIENT SUCCESSFULLY. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665154 ↗
• InjuryMar 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A POLYPECTOMY PROCEDURE, THE POLYLOOPS', "HAND PART" BROKE DOWN. THE POLYLOOPS CABLE WAS STUCK INSIDE THE SCOPE AND INSIDE OF THE PATIENT. TROUBLESHOOTING WAS DONE USING A SIDE CUTTERS TO GET THE CABLE OUT FROM THE PATIENT. IT TOOK ABOUT 30 MINUTES TO GET THE CUTTERS AND GET THE CABLE OUT FROM THE PATIENT. THE PROCEDURE WAS STILL COMPLETED WITH THE USE OF THE SAME DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509580 ↗
• MalfunctionFeb 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SUBJECT DEVICE DID NOT TRIP OR DETACH FROM THE END OF THE WIRE AS IT SHOULD WORK. THE ISSUE OCCURRED DURING AN ENDOSCOPY PROCEDURE. ANOTHER PRODUCT LOOP CUTTER WAS USED TO REMOVE THE PRODUCT WIRE AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472829 ↗
• InjuryNov 20, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC LIGATURE, WHEN TIGHTENING THE LOOP AROUND THE POLYP, THE METAL ROD BENT AT THE HANDLE AND BROKE, AND A SECOND ENDOSCOPE HAD TO BE USED TO CUT THE LOOP. THE USER THEN USED A SECOND DEVICE AFTER CUTTING THE LOOP OF THE FAULTY DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735012 ↗
• MalfunctionNov 18, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, THE LIGATING DEVICE HAD DIFFICULTY, WHEN THE DEVICE WAS BEING RELEASED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE ISSUE OCCURRED, DURING ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. THERE WERE REPORTS OF A 2 MINUTE DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20716858 ↗
• InjurySep 9, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE GASTRIC MASS WAS LOCATED AT THE BOTTOM OF THE STOMACH. THE LOOP WAS BEING USED FOR TISSUE SUTURING. IT WAS CONFIRMED THAT THE DETACHED LOOP DID NOT FALL INTO THE PATIENT¿S BODY. THE PATIENT ONLY SUSTAINED MINOR ESOPHAGEAL MUCOSAL DAMAGE. ALTHOUGH THERE WAS REPORT OF MINOR BLEEDING, THE BLEEDING WAS NOT RELATED TO THE ESOPHAGEAL DAMAGE. HOWEVER, THE SOURCE OF THE BLEEDING WAS NOT PROVIDED. THE PROCEDURE WAS PROLONGED BY 10 MINUTES TO TROUBLESHOOT THE ISSUE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTIONS OR HOSPITALIZATION AND IS REPORTEDLY ¿DOING GOOD.¿

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 20172683 ↗
• InjuryAug 23, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS ALSO REPORTED THAT DURING THE ENDOSCOPIC RESECTION OF THE HUGE INTESTINAL POLYP, WHILE ATTEMPTING TO RELEASE THE NYLON ROPE (LOOP), THE WIRE BROKE AND COULD NOT BE RELEASED. THE RESECTION WAS INTERRUPTED. THE LOOP HAD TO BE CUT WITH THE LOOP CUTTER AND REPEATEDLY PULLED UNTIL IT FINALLY RELEASED. THE POLYP WAS FINALLY REMOVED AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057563 ↗
• MalfunctionAug 20, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A POLYPECTOMY, THE DEVICE FAILED TO DEPLOY PROPERLY AND BECAME STUCK IN THE PATIENT. CUTTING THE HANDLE/INTERNAL WIRE DID NOT RELEASE. THERE WAS DIFFICULTY REMOVING THE SCOPE OVER THE FAILED DEVICE FOR FEAR OF RIPPING OFF POLYP. EVENTUALLY THE CUSTOMER USED A SCISSOR TOOL THROUGH A DIFFERENT SCOPE AND CUT THE DEVICE OFF SAFELY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000631 ↗
• MalfunctionAug 6, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE LIGATING DEVICE WAS UNABLE TO DETACH THE LOOP FROM THE POLYPLOOP AND THE HANDLE BROKE OFF. THE ISSUE OCCURRED DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918519 ↗
• InjuryMay 15, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SINGLE USE LIGATING DEVICE COULD NOT BE RELEASED (PRESUMED FROM A POLYP). THE CABLE HAD TO BE CUT USING A CLAMP. ANOTHER DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE; NO PATIENT INJURY OCCURRED. ADDITIONAL INFORMATION REGARDING THE PROCEDURE AND INTERVENTION WAS REQUESTED MULTIPLE TIMES, BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323991 ↗
• InjuryApr 22, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED DURING A POLYP LIGATION AT THE ASCENDING COLON THE LOOP DID NOT DETACH FROM THE HOOK OF THE SUBJECT DEVICE. AFTER GARLANDING THE LOOP, THE LOOP GOT TIGHTENED. THEY ATTEMPTED TO DEPLOY THE LOOP BUT IT DID NOT DETACH FROM THE HOOK. THEY CUT THE LOOP FROM THE HANDLE AND THE CABLE CONNECTING HOOK AND HANDLE MECHANISM BROKE. AFTER THEY CUT IT, THEY WERE ABLE TO REMOVE IT. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT AND THERE WAS NO INJURY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19158951 ↗
• InjuryMar 11, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, DURING THE MIDDLE OF THE COLONOSCOPY SCREENING, THE ENDOLOOP LIGATING DEVICE WAS SECURED TO THE POLYP AND WAS UNABLE TO BE RELEASED, AND HAD TO BE CUT WITH LOOP CUTTERS. THE CABLE AND THE HANDLE WERE SAVED, HOWEVER THE CABLE SNAPPED INSIDE THE HANDLE, BUT OUTSIDE OF THE PATIENT. THE ISSUE CAUSED A 45-MINUTE PROCEDURAL DELAY WHILE THE PATIENT WAS UNDER CONSCIOUS SEDATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874388 ↗
• InjuryMar 11, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, DURING THE MIDDLE OF THE COLONOSCOPY SCREENING, THE ENDOLOOP LIGATING DEVICE WAS SECURED TO THE POLYP AND WAS UNABLE TO BE RELEASED, AND HAD TO BE CUT WITH LOOP CUTTERS. THE CABLE AND THE HANDLE WERE SAVED, HOWEVER THE CABLE SNAPPED INSIDE THE HANDLE, BUT OUTSIDE OF THE PATIENT. THE ISSUE CAUSED A 45-MINUTE PROCEDURAL DELAY WHILE THE PATIENT WAS UNDER CONSCIOUS SEDATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874384 ↗
• InjuryMar 4, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN UNSPECIFIED NUMBER OF COLON POLYPECTOMY PROCEDURES, THE PLASTIC PARTS OF THE COIL SHEATH AND STOPPER OF THE SUBJECT DEVICE WERE BENT WHEN THE UNIDENTIFIED SCOPE WAS ANGLED, AND THE HANDLE ON THE HAND SIDE WAS BENT AS WELL WHILE STRANGLING A POLYP AND PUSHING OUT THE HANDLE TO RELEASE THE SNARE. THE METAL PART OF THE SNARE BROKE AND COULD NOT BE RELEASED, AND THE DEVICE HAD TO BE CUT WITH NIPPERS AND OTHER UNSPECIFIED TOOLS. THE PROCEDURES WERE COMPLETED WITH THE SAME DEVICE. THE CUSTOMER COULD NOT DETERMINE THE EXACT DATES AND NUMBER OF TIMES THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18831665 ↗
• InjuryMar 4, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED, THE PLASTIC PARTS OF THE COIL SHEATH AND STOPPER OF THE SUBJECT DEVICE WERE BENT WHEN THE UNIDENTIFIED SCOPE WAS ANGLED, AND THE HANDLE ON THE HAND SIDE WAS BENT AS WELL WHILE STRANGLING A POLYP AND PUSHING OUT THE HANDLE TO RELEASE THE SNARE DURING A COLON POLYPECTOMY. THE METAL PART OF THE SNARE BROKE AND COULD NOT BE RELEASED, AND THE DEVICE HAD TO BE CUT WITH NIPPERS AND OTHER UNSPECIFIED TOOLS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18831583 ↗