LigaSure XP LXMJ23SRecalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10884521830929), received between Jan 2, 2024 and Sep 30, 2026 — classified as 72 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (23 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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Energy Output Problem

  It was reported that during lobectomy procedure, the device was connected to the generator and output sound was heard; however, it could not be confirmed that output was being delivered in the surgical field. The device had no seal with no evidence of energy delivery and end tones heard. A new product was connected to the same generator and the first sealing was performed without any issues on approximately 8 to 10 millimeter in the interlobar / interlobar region. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941719 ↗
• MalfunctionSep 22, 2026Peeled/Delaminated; Detachment of Device or Device Component

  It was reported that, during a procedure, the lower jaw part of the device was detached from the tip. Another device was used with the same generator and it worked fine. Nothing fell on patient's cavity and there was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854205 ↗
• MalfunctionSep 4, 2026Energy Output Problem

  It was reported that during a total laparoscopic hysterectomy procedure, the handpiece worked fine initially and it gradually stopped working. The seal completion sounded immediately after tissue was clamped, but no seal could be done. It stopped creating seals. Another handpiece was used with the same generator and it worked fine.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613177 ↗
• MalfunctionAug 26, 2026Communication or Transmission Problem; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453060 ↗
• MalfunctionJul 28, 2026Failure to Seal

  Would not complete seal.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053584 ↗
• MalfunctionMay 18, 2026Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A THORACOSCOPIC LUNG RESECTION, THE HANDLE WAS VERY STIFF/HARD TO SQUEEZE DURING OUTPUT. THEREFORE, IT WAS REPLACED WITH ANOTHER NEW SAME PRODUCT. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DEVICE'S JAW OPENING AND CLOSING MECHANISM WAS FUNCTIONAL, HOWEVER IT WAS STIFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203826 ↗
• MalfunctionApr 24, 2026Energy Output Problem; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING PANCREATICODUODENECTOMY (PD), THE HANDPIECE JAWS CANNOT BE OPENED OR CLOSED AFTER 30 MINUTES OF USE. IT WAS APPLIED TO THE ADIPOSE (FAT) TISSUE WHEN THE ISSUE OCCURRED AND WAS FORCIBLY OPENED TO BE REMOVED. THE JAW AREA WAS CLEANED EVERY TIME IT GETS DIRTY. THE KNIFE BLADE WAS NOT EXTENDED NOR PROTRUDED BEYOND THE JAWS. ANOTHER HANDPIECE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO BLEEDING AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982048 ↗
• MalfunctionFeb 13, 2026Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A PANCREATICODUODENECTOMY PROCEDURE, THE DEVICE WAS UNABLE TO SEAL THE 1-2MM PANCREAS WHEREIN THERE WAS A SEAL COMPLETION SOUND, BUT THERE WAS NO EVIDENCE OF ENERGY SUPPLY AND NO REGRASP ALERT. THERE WERE 20 GOOD SEALS COMPLETED BEFORE THE PROBLEM OCCURRED. THE STAFF CLEANED THE AREA AROUND THE JAW EVERY TIME THAT SOME DIRT WAS OBSERVED IN THE JAW REGION. ANOTHER LIGASURE WAS APPROPRIATELY USED WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332773 ↗
• MalfunctionFeb 13, 2026Mechanical Problem; Difficult to Open or Close; Intermittent Energy Output; Separation Problem

  IT WAS REPORTED THAT DURING A SEALING PROCEDURE, AFTER 3 HOURS OF SURGERY, ON THE TISSUE IN PELVIC AREA, THE DEVICE BECAME DIFFICULT OR IMPOSSIBLE TO OPEN, RESULTING IN THE JAWS BECOMING STUCK ON TISSUE, AND THE KNIFE BLADE COULD NOT ADVANCE. TISSUE WAS NOTED TO BE STICKING TO THE JAWS, CONSISTENT WITH ESCHAR BUILDUP. THE JAWS WERE FORCED OPEN TO REMOVE THE DEVICE. THE DEVICE WAS CLEANED OFTEN BECAUSE THEY KNEW THAT CLEANING WAS NECESSARY. THE PROCEDURE WAS EXTENDED BY 30 MINUTES AS A RESULT, AND THE SURGEON CHANGED THE DEVICE AFTER TESTING THE REQUESTED DEVICE. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332515 ↗
• MalfunctionJan 16, 2026Mechanical Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING USE THE DEVICE WAS NO LONGER ABLE TO SEAL, AND THE KNIFE'S MOVEMENT ALSO WORSENED. ANOTHER LIGASURE WAS PROPERLY USED WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091794 ↗
• MalfunctionJan 15, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, THE DEVICE WAS UNABLE TO SEAL. THERE WAS A SOUND OF SEAL COMPLETION, BUT THERE WAS NO EVIDENCE OF ENERGY SUPPLY. THERE WAS NO RE-GRASP ALERT OR ERROR OCCURRED. THE AREA AROUND THE JAW WAS CLEAN AND IT WAS UNABLE TO CREATE A GOOD SEAL AS THE ISSUE STARTED FROM THE BEGINNING OF THE PROCEDURE. ANOTHER LIGASURE WAS APPROPRIATE FOR USE WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078256 ↗
• MalfunctionDec 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING ADHESION DETACHMENT ON THORACOSCOPIC LUNG SEGMENTECTOMY, THE DEVICE'S JAW WAS DIFFICULT TO OPEN WHEN APPLIED TO THE TISSUE BUT OPENED TO THE END BY OPENING THE JAW WITH BOTH HANDS. THE DEVICE'S JAWS WERE CLEANED WHENEVER ESCHAR WAS IDENTIFIED. THE KNIFE BLADE WAS NOT EXTENDED AND DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. ANOTHER LIGASURE WAS PROPERLY USED WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875442 ↗
• MalfunctionNov 25, 2025Mechanical Problem; Retraction Problem; Mechanical Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A HEPATIC PROCEDURE, THE KNIFE BLADE WAS STUCK, IT COULD NOT ADVANCE AND COULD NOT RETRACT. THE KNIFE BLADE WAS NOT EXTENDED NOR PROTRUDED BEYOND THE EDGE OF THE JAWS. THE DEVICE WAS PLUGGED INTO A GENERATOR, AND ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643152 ↗
• MalfunctionNov 25, 2025Mechanical Problem; Retraction Problem; Mechanical Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A HEPATIC PROCEDURE, THE KNIFE BLADE WAS STUCK, IT COULD NOT ADVANCE AND COULD NOT RETRACT. THE KNIFE BLADE WAS NOT EXTENDED NOR PROTRUDED BEYOND THE EDGE OF THE JAWS. THE DEVICE WAS PLUGGED INTO A GENERATOR WITH SOFTWARE VERSION 5.0. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643062 ↗
• MalfunctionNov 6, 2025Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN USED FOR NORMAL LUNGS, THE DEVICE COULD NOT SEAL (THERE WAS A SEAL COMPLETION SOUND, BUT THERE WAS NO EVIDENCE THAT ENERGY WAS SUPPLIED). A RE-GRASP ALERT OCCURRED, BUT NO BLEEDING WAS OBSERVED. THE JAW PART WAS IN A CLEAN CONDITION AND WAS CLEANED EVERY TIME IT GOT DIRTY. ANOTHER DEVICE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487554 ↗
• MalfunctionOct 31, 2025Failure to Advance

  SEALER/DIVIDER BLADE STOPPED ADVANCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435794 ↗
• MalfunctionOct 27, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT, DURING OPEN WHIPPLE PROCEDURE, 30 MINUTES INTO THE CASE THE DEVICE HAD PARTIAL SEALING ON THE LESS THAN 7MM LYMPHATIC TISSUE. THERE WAS EVIDENCE OF ENERGY DELIVERY, THERE WAS NO REGRASP ALERT, AND END TONES WAS HEARD. THERE WAS NO BLEEDING AFTER CUTTING. THE DEVICE JAW WAS CLEANED WHEN THERE DEBRIS OR ESCHAR. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392394 ↗
• MalfunctionOct 15, 2025Device Alarm System; Energy Output Problem; Difficult or Delayed Activation; Intermittent Energy Output; Device Alarm System; Energy Output Problem; Difficult or Delayed Activation; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A BOWEL RESECTION PROCEDURE, THERE WAS AN ENERGY ACTIVATION ISSUE AND SEALING WAS INADEQUATE OR PARTIAL, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THE SEAL CYCLE FOR THE FIRST FEW SEALS WAS MUCH LONGER THAN USUAL. IT WAS ONLY PARTIALLY SEALING AND CONTINUALLY GIVEN THE ALARM THAT THE SEAL CYCLE WASN'T COMPLETE, DESPITE MAINTAINING THE ACTIVATION FOR A LONG TIME. THE JAWS WERE INSPECTED FOR DEBRIS AND NONE WAS FOUND. THE JAWS WERE CLEANED SEVERAL TIMES DURING THE PROCEDURE. APPROXIMATELY THREE GOOD SEALS OCCURRED BEFORE THE ISSUE, AND THE TISSUE BEING SEALED WAS THICK MESENTERY. THE DEVICE WAS PLUGGED INTO A GENERATOR, AND ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294178 ↗
• MalfunctionSep 18, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDPIECE COULD NOT SEAL. THERE WAS A SEAL COMPLETION SOUND, BUT THERE WAS NO EVIDENCE THAT ENERGY WAS SUPPLIED. A NEW HANDPIECE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084163 ↗
• MalfunctionSep 11, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, PRIOR TO USE, THE DEVICE JAWS REMAINED CLOSED AFTER THE LEVER WAS PULLED TOWARD THE USER, AND IT WAS DIFFICULT TO OPEN THEM. A NEW UNIT OF THE SAME DEVICE WAS OPENED AND WAS ABLE TO BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026775 ↗
• MalfunctionAug 4, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE KNIFE BLADE OF THE DEVICE COULD NOT BE RETRACTED. THE DEVICE WAS CONNECTED TO A GENERATOR WITH THE LATEST SOFTWARE VERSION. A NEW DEVICE WAS USED WITH THE SAME GENERATOR SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701256 ↗
• MalfunctionJul 18, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE'S KNIFE TRIGGER BECAME STUCK IN THE PULLED POSITION WHEN GRASPING TISSUE AFTER COAGULATING AND CUTTING. THE SURGICAL PROCEDURE WAS EXTENDED BY 10 MINUTES WHILE THE NEW INSTRUMENT WAS OPENED AND INSTALLED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541489 ↗
• MalfunctionJun 10, 2025Retraction Problem; Separation Problem; Retraction Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE LIVER RESECTION, THE FIRST INSTRUMENT WAS THE TRIGGER TO THE KNIFE STUCK AND COULD NOT RETRACT AFTER HALF AN HOUR OF USE. THE SECOND INSTRUMENT WAS THE SAME AND STUCK DIRECTLY. THE DEVICE WAS CLEAN. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175803 ↗
• MalfunctionJun 10, 2025Retraction Problem; Intermittent Energy Output; Retraction Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING THE LIVER RESECTION, THE FIRST INSTRUMENT WAS THE TRIGGER TO THE KNIFE STUCK AND COULD NOT RETRACT AFTER HALF AN HOUR OF USE. THE SECOND INSTRUMENT WAS THE SAME AND STUCK DIRECTLY. THE DEVICE WAS CLEAN. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175786 ↗
• MalfunctionJun 9, 2025Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  ACCORDING TO THE REPORTER DURING A THORACOSCOPY PULMONARY RESECTION, THE HANDPIECE HAD INADEQUATE/WEAK SEALING WHEN USED IN RIGHT PULMONARY PERIARTERIAL RESECTION. ENERGY OUTPUT AND SEAL COMPLETION SOUND WERE CONFIRMED. THE AREA AROUND THE JAW WAS CLEANED EVERY TIME IT GETS DIRTY. A NEW HANDPIECE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171223 ↗