LigaSure XP LXMJ44LRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521830950), received between Dec 6, 2023 and Sep 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that during a laparoscopic sleeve gastrectomy, the device latch sealer/divider 44 cm was used to seal average-thickness momentum and short gastric vessels during mobilization of the stomach. Within the first 10 seals, after approximately 5 successful seals and with no jaw cleaning required, an inadequate/partial device seal occurred despite evidence of energy delivery and audible end tones. There were no errors or alerts. Bleeding of 100ml with the device seal, occurred after cutting. The device was connected to an generator, and another device was used successfully with the same generator. Surgical time was extended by 45 minutes. Blood transfusion was not required.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50727336 ↗
• MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE, THE FIRST DEVICE BURNT THE CIRCUNDANT SPACE OF THE INTESTINE ADJACENT TO THE SURGICAL SITE. THE SECOND DEVICE HAD A FAILURE IN THE BUTTON ON THE ACTION HANDLE, WHICH MADE IT UNUSABLE DURING THE SURGERY. THE SURGEON PROCEEDED TO SUTURE THE PERFORATION IN THE ADJACENT INTESTINE.

  Patient problems: Bowel Burn; Bowel Perforation; Tissue Breakdown

  MAUDE report 25056695 ↗
• MalfunctionFeb 6, 2026Self-Activation or Keying

  ACCORDING TO THE REPORTER DURING A DA VINCI LAPAROSCOPIC BLADDER MALIGNANT TUMOR SURGERY, THE DEVICE UNINTENTIONALLY OUTPUTTED. IT OUTPUTTED EVEN THOUGH THE OUTPUT BUTTON HAD NOT BEEN PRESSED. EVEN THOUGH IT WAS A RATCHET TYPE, IT OUTPUTTED WHEN THE HANDLE WAS SQUEEZED, SO IT WAS DETERMINED THAT CONTINUING USE WAS DANGEROUS AND ANOTHER LXMJ44L WAS TAKEN OUT USING THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278674 ↗
• MalfunctionAug 20, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT 24 HOURS POST LAPAROSCOPIC SLEEVE GASTRECTOMY, THE PATIENT HAD BLEEDING. THE SURGEON CLAIMED THAT THE POSTOPERATIVE BLEED WAS THOUGHT TO HAVE ORIGINATED FROM THE USE OF THE LIGASURE DEVICE. NO OTHER LIGASURE SITED FOUND REOPENED. THERE WERE NO ISSUES NOTED DURING THE CASE EXCEPT FOR OCCASIONAL BLEEDING. IT WAS OBSERVED DURING THE PROCEDURE THAT THERE WAS ACTIVATION TONE AND END TONES HEARD AND THERE WAS NO RE-GRASP ALARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22851544 ↗
• MalfunctionApr 3, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL PROSTATECTOMY WITH ROBOT SUPPORT, THE DEVICE'S TIP INSULATION WAS DETACHED AND FELL INTO P ERIPROSTATIC BLOOD VESSEL. THE BROKEN PIECE WAS RETRIEVED. ANOTHER DEVICE WAS USED APPROPRIATELY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769987 ↗
• MalfunctionAug 20, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, IN THE STOMACH AREA, THE THICKNESS OF THE TISSUE WAS WITHIN NORMAL RANGE, SEALING WAS I NADEQUATE/PARTIAL (WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD). SOME SEALS DID NOT HOLD/ BURST OPEN AFTER A FEW MINUTES, WHILE SOME SEALS DID NOT EVEN HAPPEN. THERE WAS NO ERROR MESSAGE FROM ELECTROSURGICAL UNIT AT ALL. THE SEAL SHOWED EVIDENCE OF ENERGY DELIVERY, BUT BLED AFTER CUTTING. THERE WAS NO BLOOD TRANSFUSION DONE BECAUSE THE DEVICE WAS SWOPPED OUT WITHIN 30MINS INTO THE PROCEDURE. THE PATIENT WAS NOT ON ANY MEDICATIONS. THE PROCEDURE WAS EXTENDED BY 30 MINUTES DUE TO THE PRODUCT ISSUE. THE JAWS WERE CLEANED EVERY TIME IT WAS REMOVED FROM THE PATIENT. TRADITIONAL BIPOLAR MARYLAND PLUS USE OF LF1944 SUBSEQUENTLY WERE USED TO STOP THE BLEEDING AND TO CONTINUE WITH THE SURGERY USING THE SAME GENERATOR AND IT WORKED FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20001811 ↗
• MalfunctionJan 16, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD ENERGY ACTIVATION/SEALING ISSUE ACTIVATION AND END TONE HEARD BUT SEALING WAS INADEQUATE/PARTIAL AND BLEEDS AFTER CUTTING. THE VESSEL WAS FULLY TRANSECTED, BUT BLEEDING WAS OBSERVED DIRECTLY FROM THE DEVICE'S SEAL. DOCTOR WAS ABLE TO RESEAL USING SAME DEVICE AND FINISH CASE WITHOUT ISSUE BUT OCCURRED IN TWO CASES IN A ROW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18518448 ↗
• MalfunctionJan 12, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE¿S ACTIVATION AND END TONE WERE HEARD BUT SEALING WAS INADEQUATE/PARTIAL. THE DEVICE ACTIVATED TO END TONE BY THE OMENTUM AT THE BEGINNING OF SLEEVE AND GOT BLEEDERS DIRECTLY FROM THE SEAL SITE. THE PHYSICIAN WAS ABLE TO RESEAL AND CLEAN IT UP SO THE DEVICE DID NOT NECESSARILY FAIL BUT DID NOT SEAL ON FIRST ATTEMPT AS IT SHOULD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18507605 ↗
• MalfunctionDec 6, 2023Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING ROBOTIC SLEEVE GASTRECTOMY, THE DEVICE HAD NO SEAL. ALARM AND END TONE WERE UNKNOWN AND THERE WAS NO ENERGY DELIVERY. FOR MAJORITY OF THE PROCEDURE THE DEVICE WAS WORKING PROPERLY AND THEN AT THE END OF THE CASE THE DEVICE STOPPED ACTIVATING. WHEN THEY PRESSED THE BUTTON TO ACTIVATE THEY SAID IT WAS NOT ACTIVATING AT ALL. THEY TRIED UNPLUGGING AND REPLUGGING THE DEVICE BUT NOTHING WAS WORKING. THERE WAS NO BLEEDING AND BLOOD TRANSFUSION WAS NOT NECESSARY. ANOTHER DEVICE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277712 ↗