LigaSure LF1944Recalls & reported problems

Summary

The FDA's MAUDE database contains 369 adverse event reports that list this exact device (DI 10884521705920), received between Jan 8, 2018 and Sep 30, 2026 — classified as 1 death, 50 injuries, 318 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (202 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 369 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Energy Output Problem; Failure to Cut

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50953335 ↗
• MalfunctionJun 8, 2026Device Remains Activated; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A HIATUS HERNIA REPAIR WITH FUNDOPLICATION, THE DEVICE¿S PURPLE ACTIVATION BUTTON STUCK WHEN DEPRESSED AND CONTINUED ACTIVATING. AN ERROR MESSAGE APPEARED ON THE GENERATOR. THE SURGEON REPEATEDLY PULLED THE PURPLE ACTIVATION BUTTON OUT BUT ENDED IN OPENING A NEW DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428401 ↗
• InjuryMay 28, 2026Energy Output Problem; Difficult or Delayed Activation

  IT WAS REPORTED THAT SIX HOURS AFTER GASTRIC SLEEVE/SASI (SINGLE ANASTOMOSIS SLEEVE ILEAL BYPASS) PROCEDURE, THE PATIENT HAD TWO PINTS OF BLOOD TRANSFUSION DUE TO HYPOVOLEMIC SHOCK CAUSED BY 1500ML ENDOSCOPIC BLEEDING. A REOPERATION WAS PERFORMED TO DETECT THE BLEEDING SOURCE AND STOP THE BLEEDING. NO MASSIVE TRANSFUSION PROTOCOL (MTP) WAS INITIATED. THE EVENT REPORTEDLY EXTENDED HOSPITALIZATION FOR AN UNKNOWN DURATION AND WAS ADMITTED TO SEMI-INTENSIVE CARE UNIT. IT WAS NOTED THAT DURING A PROCEDURE, THE DEVICE HAD INADEQUATE OR PARTIAL EVIDENCE OF ENERGY DELIVERY AND END TONES BEING HEARD. THE SEAL REPORTEDLY SHOWED EVIDENCE OF ENERGY DELIVERY BUT BLED AT GASTRO-DIAPHRAGMATIC VESSELS, BACK OF THE LEFT PILLARS AFTER CUTTING, AND THE SEALING TIME OF THE VESSEL WAS OBSERVED TO BE SHORT. IT WAS NOTED THAT THE JAWS WERE CLEANED APPROXIMATELY FOUR TIMES DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock; Laceration(s)

  MAUDE report 25311990 ↗
• MalfunctionMay 15, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE HAD AN INADEQUATE OR PARTIAL VESSEL SEALING, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. IT WAS ALSO REPORTED THAT THE SEAL SHOWED EVIDENCE OF ENERGY DELIVERY BUT BLEEDING OCCURRED AFTER CUTTING. ANOTHER DEVICE WAS REPORTEDLY USED SUCCESSFULLY WITH THE SAME GENERATOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25181069 ↗
• MalfunctionMar 2, 2026Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE INVOLVING THE LIGASURE VESSEL SEALING DEVICE, AN ENERGY ACTIVATION/SEALING ISSUE OCCURRED WHILE SEALING GASTRIC VESSELS. THE SEALING WAS INADEQUATE OR PARTIAL, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THERE WAS NO RE-GRASP OR ERROR OCCURRED. ONLY A COUPLE OF GOOD SEALS TOOK PLACE BEFORE THE ISSUE OCCURRED. 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 24479803 ↗
• MalfunctionMar 2, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE HAD NO SEAL WITH NO EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD WHEN APPLIED TO GASTRIC VESSELS. 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 24479782 ↗
• MalfunctionFeb 25, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A SINGLE ANASTOMOSIS DUODENO-ILEAL BYPASS WITH SLEEVE GASTRECTOMY (SADI-S), THE DEVICE HAD INADEQUATE OR PARTIAL SEALING WITH NO REGRASP ALERT BUT EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD AFTER MORE THAN 20 SUCCESSFUL SEALS ON LESS THAN 7 MM RIGHT GASTRIC TISSUE NEAR THE PYLORUS. THE KNIFE BLADE WAS REPORTED TO HAVE CUT PAST THE AREA SEALED BY THE SEAL PLATE. THE DEVICE WAS CLEANED FREQUENTLY. MINIMAL OF 2ML BLEEDING OCCURRED AFTER CUTTING, DESPITE THE SEAL SHOWING EVIDENCE OF ENERGY DELIVERY. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY AND NO BLOOD TRANSFUSION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442612 ↗
• MalfunctionFeb 16, 2026Peeled/Delaminated; Separation Problem

  IT WAS REPORTED THAT DURING PROCEDURE, TISSUE WAS STICKING TO THE JAWS FROM THE START OF THE CASE. THE SURGEON REPORTED THAT THE JAWS WERE STICKY FROM THE FIRST SEAL AND FELT AS THOUGH THERE WAS NO NANO COATING PRESENT, BUT NOTHING FELL OFF THE INSTRUMENT. NO ESCHAR BUILDUP ON THE JAWS. THE DEVICE WAS REPLACED AFTER TEN SEALS, ALL OF WHICH WERE COMPLETED BUT REMAINED STICKY, WITH ANOTHER LF1944 HANDPIECE. NO ISSUE WAS OBSERVED WITH THE SECOND HANDPIECE ON 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 24344612 ↗
• MalfunctionFeb 3, 2026Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE'S TIPS WERE STUCK TOGETHER AND DID NOT OPEN EASILY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244402 ↗
• MalfunctionJan 27, 2026Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE HAD AN ACTIVATION BUTTON WAS DIFFICULT TO PRESS AS IT WAS VERY DIFFICULT TO PUSH OR PULL THE TIP. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186634 ↗
• MalfunctionJan 13, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING MOBILIZATION OF THE GREATER CURVATURE OF THE STOMACH IN A TRADITIONAL DUODENAL SWITCH LAPAROSCOPIC PROCEDURE, THE DEVICE EXHIBITED INADEQUATE OR PARTIAL SEALING, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD WHEN APPLIED TO MESENTERY OF THE GREATER OF THE STOMACH. USED ANOTHER DEVICE AND WORKED FINE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 24064242 ↗
• MalfunctionJan 12, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING MOBILIZATION OF THE STOMACH IN A DUODENAL SWITCH LAPAROSCOPIC PROCEDURE, THE DEVICE WAS APPLIED AND BLEEDING OCCURRED. THE DEVICE DID NOT SEAL TISSUE AS INTENDED, WITH NO EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THE SURGEON CLAIMED THAT IT WAS SEALING PROPERLY EVERYWHERE, EXCEPT ON THE GREATER CURVATURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24036032 ↗
• MalfunctionJan 12, 2026Energy Output Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE WAS NOT SEALING PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 24035772 ↗
• MalfunctionJan 8, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD NO SEAL WITH NO EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THE DEVICE WAS PLUGGED INTO AN LS10 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 24000814 ↗
• MalfunctionJan 6, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC DUODENAL SWITCH PROCEDURE, WHILE MOBILIZING THE GREATER CURVATURE OF THE STOMACH UP TOWARD THE SPLEEN, THE DEVICE EXHIBITED INADEQUATE OR PARTIAL SEALING, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD WHEN APPLIED TO SHORT GASTRIC VESSELS. MINIMAL BLEEDING OCCURRED AFTER CUTTING. USED ANOTHER LIGASURE DEVICE AND WORKED FINE.

  Patient problems: Insufficient Information

  MAUDE report 23973650 ↗
• MalfunctionJan 6, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A DUODENAL SWITCH WITH A SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE EXHIBITED INADEQUATE OR PARTIAL SEALING WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. USED ANOTHER LIGASURE DEVICE AND WORKED FINE.

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

  MAUDE report 23973268 ↗
• MalfunctionDec 19, 2025Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A GASTRIC SLEEVE, WHILE SEALING A MESENTERY, AFTER A FEW GOOD SEALS, THE DEVICE STOPPED SEALING, THERE WAS NO EVIDENCE OF ENERGY DELIVERY, NO RE-GRASP ALERT OR OTHER ERROR OCCURRED, AND END TONES WERE HEARD. THE JAWS WERE CLEANED FREQUENTLY, THERE WAS NO BLEEDING, BUT THE PROCEDURE WAS EXTENDED FOR 5 MINUTES WHILE ANOTHER DEVICE THAT WORKED SUCCESSFULLY WITH THE GENERATOR WAS SOURCED FROM THE STOCK ROOM.

  Patient problems: Insufficient Information

  MAUDE report 23854419 ↗
• MalfunctionDec 15, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC MODIFIED DUODENAL SWITCH PROCEDURE INVOLVING MOBILIZATION OF THE LOWER STOMACH AND SEALING OF THE SHORT GASTRIC VESSELS, THE TWO LIGASURE DEVICES HAD INADEQUATE OR PARTIAL SEALING, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. BLEEDING OCCURRED AFTER CUTTING FOLLOWING ATTEMPTED VESSEL SEALING DURING THE PROCEDURE. THERE WAS NO REGRASP ALERT OR OTHER ERROR THAT OCCURRED. BLOOD TRANSFUSION WAS NOT NECESSARY AND NO MEDICAL OR SURGICAL INTERVENTION OR REOPERATION WAS DONE TO STOP THE BLEEDING. A NEW LIGASURE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23803080 ↗
• MalfunctionDec 15, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC MODIFIED DUODENAL SWITCH PROCEDURE INVOLVING MOBILIZATION OF THE LOWER STOMACH AND SEALING OF THE SHORT GASTRIC VESSELS, THE TWO LIGASURE DEVICES HAD INADEQUATE OR PARTIAL SEALING, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. BLEEDING OCCURRED AFTER CUTTING FOLLOWING ATTEMPTED VESSEL SEALING DURING THE PROCEDURE. THERE WAS NO REGRASP ALERT OR OTHER ERROR THAT OCCURRED. BLOOD TRANSFUSION WAS NOT NECESSARY AND NO MEDICAL OR SURGICAL INTERVENTION OR REOPERATION WAS DONE TO STOP THE BLEEDING. A NEW LIGASURE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23802991 ↗
• MalfunctionDec 2, 2025Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) PROCEDURE, THE DEVICE HAD INADEQUATE OR PARTIAL VESSEL SEALING WITH REGRASP ALERT, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. MINIMAL BLEEDING OCCURRED AFTER CUTTING. THE DEVICE'S JAW WAS CLEANED AFTER EVERY SEAL. 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 23691584 ↗
• MalfunctionNov 25, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING LAP HERNIORRHAPHY, THE DEVICE STOPPED OPENING DURING MOBILIZATION. IT DID NOT GET STUCK ON A TISSUE. ANOTHER LIGASURE DEVICE USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642831 ↗
• MalfunctionAug 20, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE WAS NOT SEALING, THERE WAS NO EVIDENCE OF DELIVER ENERGY AND END TONES WERE HEARD. 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 22852035 ↗
• MalfunctionAug 17, 2025Detachment of Device or Device Component; Intermittent Energy Output; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE DEVICE STOPPED WORKING (WITH EVIDENCE OF ENERGY DELIVERY AND NO END TONES HEARD). THE JAWS WERE CLEANED AFTER 3¿5 USES AND WERE STILL ABLE TO COMPLETE A GOOD SEAL 4-5 TIMES AFTER USING. THE DEVICE WAS CONNECTED TO A GENERATOR WITH SOFTWARE VERSION 2.1, AND IT REPLACED ANOTHER DEVICE AND IT WORKED FINE. THERE WAS NO PIECE FELL INTO PATIENT'S CAVITY AND NOT ANY ADDITIONAL MEDICAL PROCEDURE NEEDED TO REMOVE THE PIECE FROM THE PATIENT. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE SEAL PLATE ON JAW B WAS FULLY DETACHED FROM THE JAW, AND WAS STUCK TO JAW A'S SEAL PLATE DUE TO ESCHAR BUILD UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824300 ↗
• MalfunctionAug 7, 2025Energy Output Problem; Difficult to Open or Close; Energy Output Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE VEIN HARVESTING PROCEDURE, THE DEVICE¿S HANDLE BECAME STUCK IN THE PULLED POSITION AND REQUIRED SIGNIFICANT EFFORT AND MULTIPLE ATTEMPTS TO RETURN IT TO THE OPEN POSITION. THERE WAS AN INADEQUATE OR PARTIAL SEALING, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD BUT NO REGRASP ALERT. BLEEDING OCCURRED AFTER CUTTING, FOLLOWING AN ATTEMPTED SEAL OF VEINS WITH TISSUE LESS THAN 7 MM THICK. THE JAWS WERE CLEANED SEVERAL TIMES DURING THE PROCEDURE. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22745708 ↗
• MalfunctionJul 24, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS AN ENERGY ACTIVATION ISSUE, A SEALING ISSUE AND NO SEAL WAS ACHIEVED, AS THERE WAS NO EVIDENCE OF ENERGY DELIVERY AND END TONES WERE HEARD. 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 22584884 ↗