LigaSure XP LXMJ37LRecalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10884521830936), received between Oct 25, 2023 and Sep 29, 2026 — classified as 5 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (32 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Open or Close; Intermittent Energy Output

  It was reported that during the procedure, the device¿s jaw was difficult or impossible to open. The physician stated that opening and closing the jaw felt somewhat stiff at the handle and was not as smooth, but it could still function. After firing a few bites, fewer than 10, the jaw of the device became stuck and could not open. A new device was used as a replacement, and the procedure was completed smoothly. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933513 ↗
• MalfunctionSep 22, 2026Mechanical Problem; Retraction Problem; Intermittent Energy Output

  It was reported that during a left colectomy, the device was being used when the cutting trigger jammed after approximately 1 hour of use and the purple button for vessel sealing reportedly continued to function, but the cutting function did not work during mobilization of the colon. The blade would not advance or not return to its original position. The blade was stuck in the middle. The blade was not protruded. Knife trigger could not be pulled in. It was not applied at the tissue at that time. A second LigaSure device was then used with the same generator and reportedly worked as expected through the end of the procedure. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857194 ↗
• MalfunctionAug 25, 2026Mechanical Problem; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435674 ↗
• MalfunctionMay 13, 2026Device Alarm System; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO USE, TWO DEVICES ACTIVATED WHEN UNINTENDED AND THE GENERATOR SHOWED THE ERROR CODE E416. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157766 ↗
• MalfunctionApr 28, 2026Retraction Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING JAW CLOSURE PRIOR TO SEALING WITH THE DEVICE WHILE IT WAS PLUGGED INTO A GENERATOR, THE BLADE PREMATURELY ADVANCED, PUSHED THE TISSUE FORWARD AND THE TISSUE SLID OUT OF THE JAWS DURING A PROCEDURE. THE KNIFE BLADE WAS NOT EXPOSED AND DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. 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 25011583 ↗
• MalfunctionFeb 26, 2026Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE WAS USED AND EXCESSIVE BLEEDING OCCURRED ALMOST THE ENTIRE CASE, BEGINNING SHORTLY AFTER FIRST USE AND CONTINUING AT ALL STEPS OF THE PROCEDURE. SEALING WAS DESCRIBED AS INADEQUATE OR PARTIAL, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THE DEVICE COMPLETED THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24454788 ↗
• MalfunctionFeb 13, 2026Mechanical Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ADRENALECTOMY, THE DEVICE EXPERIENCED A BLADE JAM, AND THE KNIFE BLADE COULD NOT ADVANCE AND RETRACT, RESULTING IN A DELAY IN THE PROCEDURE. THE DEVICE WAS PLUGGED INTO A GENERATOR AT THE TIME OF THE EVENT, AND ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334591 ↗
• MalfunctionFeb 13, 2026Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE JAW WAS DIFFICULT OR IMPOSSIBLE TO CLOSE, THE LOCK DID NOT FULLY GRASP TISSUE, AND THE DEVICE WAS NOT FULLY LOCKED. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE JAWS WERE DAMAGED AND PIECES OF THE JAW OVERMOLD WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333131 ↗
• MalfunctionJan 8, 2026Device Alarm System; Detachment of Device or Device Component; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY WITH PARA-AORTIC LYMPH NODE DISSECTION, THE FIRST HANDPIECE STOPPED OUTPUTTING AND HAD ERROR 402. THE STOPPAGE TIMING OCCURRED RIGHT AFTER THE OUTPUT BUTTON WAS PRESSED. THERE WAS ENERGY OUTPUT, BUT NO SEAL COMPLETION SOUND. THE JAW REGION WAS IN A CLEAN CONDITION AND WAS CLEANED EVERY TIME IT GOT DIRTY. A SECOND SIMILAR DEVICE WAS ALSO TAKEN OUT, BUT AN ERROR 402 ALSO OCCURRED. THE ERROR OCCURRED SEVERAL TIMES AT THE INITIAL TIMING OF OUTPUT BUT SINCE THE NUMBER OF ERRORS SIGNIFICANTLY DECREASED, THEY COMPLETED THE PROCEDURE WITH IT. PROCEDURE WAS EXTENDED FOR 5 MINUTES DUE TO DEVICE REPLACEMENT AND THE ISSUE OCCURRED, AND THE TIME WHEN THE SEALING COULD NOT BE PERFORMED. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE PIECES OF THE OVERMOLD WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010396 ↗
• MalfunctionDec 8, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE DEVICE WAS DIFFICULT OR IMPOSSIBLE TO OPEN. THE SURGEON WAS UNABLE TO OPEN THE JAWS, BUT WERE SUBSEQUENTLY OPENED AFTER CLEANING. IT WAS NOTED THAT THE DEVICE WAS NOT APPLIED TO THE TISSUE AND THE KNIFE BLADE DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS WHEN THE ISSUE OCCURRED. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744676 ↗
• MalfunctionDec 5, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE DEVICE HAD NO SEAL AS THERE WAS NO REGRASP ALERT, NO EVIDENCE OF ENERGY DELIVERY AND THE PRESENCE OF END TONES. 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 23725438 ↗
• MalfunctionNov 24, 2025Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHROURETERECTOMY, THE SEALING OF THE HANDPIECE WAS INADEQUATE. THE ENERGY OUTPUT AND SEAL COMPLETION SOUND COULD BE CONFIRMED. THERE WAS NO RE-GRASP ALERT OR OTHER ERROR. THE JAW PART WAS IN A CLEAN CONDITION AND WAS ABLE TO COMPLETE FEWER THAN 10 GOOD SEALS BEFORE THE ISSUE OCCURRED. EVEN AFTER CHANGING THE GENERATOR TO ANOTHER FT10, THE SEALING WAS INSUFFICIENT, SO A NEW PRODUCT (HANDPIECE) WAS TAKEN OUT AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630760 ↗
• InjuryNov 5, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT AT THE START OF THE DIAGNOSTIC LAPAROSCOPY, THE DEVICE HAD INADEQUATE OR PARTIAL VESSEL SEALING, WITHOUT REGRASP ALERT BUT WITH EVIDENCE OF ENERGY DELIVERY AND END TONES WAS HEARD WHEN USED ON A NOT MORE THAN 7 MILLIMETERS THICK OMENTUM. NO JAW CLEANING WAS PERFORMED. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. PATIENT HAD EXCESSIVE BLEEDING WHICH WAS MORE THAN THE USUAL AFTER CUTTING. NO BLOOD TRANSFUSION AND NO MEDICAL/SURGICAL INTERVENTION OR REOPERATION DONE TO PATIENT TO STOP THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23475999 ↗
• MalfunctionOct 24, 2025Device Alarm System; Self-Activation or Keying; Device Alarm System; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ACTIVATED WITHOUT THE ACTIVATION BUTTON BEING PUSHED AND AN ERROR CODE OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378463 ↗
• MalfunctionOct 23, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE MARYLAND XP LATCH SEALER/DIVIDER 37CM WAS PLUGGED INTO A GENERATOR AND THE GRAY CUTTING TRIGGER ON THE HANDLE BECAME STUCK IN THE ENGAGED POSITION AND WOULD NOT RELEASE. THE KNIFE TRIGGER WAS STUCK IN THE PULLED POSITION. 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 23368090 ↗
• MalfunctionOct 20, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE COATING PART OF THE HANDPIECE HAD PEELED OFF NEAR THE UTERUS. ALL PIECES HAVE BEEN COLLECTED. A NEW HANDPIECE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335549 ↗
• MalfunctionSep 3, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, THE HANDPIECE WAS APPLIED TO UTERINE TISSUE WHEN SEVERAL DEVICE-RELATED ISSUES OCCURRED. SPECIFICALLY, THE DEVICE EXHIBITED A JAW ISSUE, BECAME DIFFICULT OR IMPOSSIBLE TO CLOSE AND OPEN AND THE LOCKING MECHANISM WOULD NOT LOCK OR OPEN AT TIMES. THESE ISSUES BEGAN AFTER THE DEVICE HAD BEEN WORKING WITHOUT ISSUE FOR APPROXIMATELY TEN MINUTES BUT WAS NOT STUCK ON TISSUE. IT WAS CLEANED FREQUENTLY AND THE KNIFE BLADE DID NOT PROTRUDE NOR EXTEND BEYOND THE EDGE OF THE JAWS. 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 22949708 ↗
• MalfunctionJul 29, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH SALPINGECTOMY, THE HANDPIECE WAS BEING USED AND INITIALLY FUNCTIONED AS INTENDED. WHEN THE DEVICE WAS USED AGAIN DURING ANOTHER PART OF THE PROCEDURE, THE JAWS WOULD NOT OPEN. IT WAS NOT APPLIED TO THE TISSUE AT THE TIME OF THE ISSUE AND JAW STOPPED WORKING HALFWAY THROUGH THE SURGERY. THE DEVICE WAS PLUGGED INTO A GENERATOR (VLFT10GEN, SOFTWARE VERSION 5.0), AND ANOTHER LIGASURE DEVICE WAS SUBSEQUENTLY USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641336 ↗
• MalfunctionJul 29, 2025Device Alarm System; Energy Output Problem; Intermittent Energy Output; Device Alarm System; Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY 5 MINUTES INTO THE CASE, THE DEVICE GAVE AN ERROR TONE MID CYCLE WHILE THE SURGEON'S HAND WAS ON THE ACTIVATION BUTTON. THEN FINISHED THE CYCLE. AN ALARM WITH ERROR CODES E504 AND E502 WERE NOTED AND THERE WAS AN ENERGY ACTIVATION AND SEALING ISSUE. SPECIFICALLY INADEQUATE OR PARTIAL SEALING, DESPITE EVIDENCE OF ENERGY DELIVERY AND END TONES BEING HEARD. THE DEVICE WAS BEING USED TO SEAL UNKNOWN VESSELS AND TISSUE OF MEDIUM THICKNESS AND APPROXIMATELY 5-10 GOOD SEALS HAD OCCURRED PRIOR TO THE ISSUE. NO CLEANING ON THE JAWS WAS DONE. ANOTHER LIGASURE 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 22641267 ↗
• MalfunctionJun 18, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING USE OF THE LIGASURE VESSEL SEALING MARYLAND XP LATCH SEALER/DIVIDER 37 CM IN THE MIDDLE OF SURGERY, THE DEVICE GOT DIFFICULT OR IMPOSSIBLE TO OPEN DUE TO A JAW ISSUE. THE DEVICE WAS NOT APPLIED ON TISSUE WHEN THE ISSUE OCCURRED. THE DEVICE WAS NOT CLEANED THAT MUCH AT ALL, AND KNIFE BLADE WAS NOT EXTENDED. THE SURGEON WAS UNABLE TO RELEASE THE HANDLE AS THE JAWS WERE STUCK TOGETHER. THE DEVICE WAS PLUGGED INTO AN FT10 GENERATOR, AND ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, OR IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282178 ↗
• MalfunctionJun 9, 2025Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT WHILE SEALING THE MESOAPPENDIX ON A LAPAROSCOPIC APPENDECTOMY. TWO DEVICES HAD INADEQUATE OR PARTIAL SEAL DESPITE EVIDENCE OF ENERGY DELIVERY, END TONES BEING HEARD AND NO REGRASP ALERT. THE SEAL SHOWED EVIDENCE OF ENERGY DELIVERY BUT BLED AFTER CUTTING, RESULTING IN AN EXTENDED SURGICAL TIME OF 15 MINUTES. THERE WERE 10 OR LESS GOOD SEAL ON 5 MM THICK OF TISSUE BUNDLES AND THE 2-3 CLEANINGS WERE PERFORMED. ANOTHER LIGASURE DEVICE USED SUCCESSFULLY WITH THE SAME GENERATOR. PATIENT HAD 50 ML OF BLEEDING AND NO BLOOD TRANSFUSION NECESSARY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22166709 ↗
• MalfunctionJun 9, 2025Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT WHILE SEALING THE MESOAPPENDIX ON A LAPAROSCOPIC APPENDECTOMY. TWO DEVICES HAD INADEQUATE OR PARTIAL SEAL DESPITE EVIDENCE OF ENERGY DELIVERY, END TONES BEING HEARD AND NO REGRASP ALERT. THE SEAL SHOWED EVIDENCE OF ENERGY DELIVERY BUT BLED AFTER CUTTING, RESULTING IN AN EXTENDED SURGICAL TIME OF 15 MINUTES. THERE WERE 10 OR LESS GOOD SEAL ON 5 MM THICK OF TISSUE BUNDLES AND THE 2-3 CLEANINGS WERE PERFORMED. ANOTHER LIGASURE DEVICE USED SUCCESSFULLY WITH THE SAME GENERATOR. PATIENT HAD 50 ML OF BLEEDING AND NO BLOOD TRANSFUSION NECESSARY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22166625 ↗
• MalfunctionMay 20, 2025Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER DURING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, THE CUTTING TRIGGER DID NOT RETURN TO ITS ORIGINAL POSITION. THE DEVICE WAS CONNECTED TO THE GENERATOR WITH SOFTWARE VERSION 2.0 AND WAS REPLACED BY ANOTHER DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051359 ↗
• MalfunctionMay 1, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE INVOLVING A V NOTES FOR HYSTERECTOMY, AFTER 5-7 ACTIVATIONS, TWO DEVICES WERE DIFFICULT/IMPOSSIBLE IN CLOSING AND OPENING, AND THE JAW WOULD NOT OPEN WITH THE KNIFE BLADE STUCK WHEN APPLIED TO THE CERVIX. THE DEVICE WAS NOT CLEANED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943187 ↗
• MalfunctionApr 17, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC V NOTES VAGINAL HYSTERECTOMY, THE HANDPIECE EXPERIENCED A JAW ISSUE, MAKING IT DIFFICULT OR IMPOSSIBLE TO OPEN WHILE TAKING DOWN A THE LIGAMENT AFTER 7 TO 8 ACTIVATIONS. THE JAW WAS NOT STUCK ON TISSUE AND THE HANDPIECE WAS NOT CLEANED DURING THE CASE. THE DEVICE WAS PLUGGED INTO AN FT10 GENERATOR WITH SOFTWARE VERSION 5.00. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858322 ↗