LigaSure LF5644Recalls & reported problems

Summary

The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 10884521521742), received between Feb 2, 2018 and Sep 28, 2026 — classified as 22 injuries, 172 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (82 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 194 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918173 ↗
• MalfunctionAug 25, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436250 ↗
• MalfunctionMay 27, 2026

  WE HAD AN INCIDENT WITH A L-HOOK LIGASURE RETRACTABLE L-HOOK LAPAROSCOPIC SEALER DIVIDER. PRODUCT NUMBER IS LF5644. IT WORKED FINE AS A LIGASURE, BUT WHEN WE DEPLOYED THE HOOK, IT WOULD NOT FUNCTION. THE DOCTOR IS FAMILIAR WITH THIS INSTRUMENTATION. IT IS NEW TO THE STAFF, BUT IT IS NOT NEW TO HER. SHE'S BEEN USING IT FOR 15 PLUS YEARS. IT IS ABOUT 945 WHEN THE ISSUE BEGAN. WE ARE DOING A LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHRECTOMY, UTERUS 250 GRAMS OR LESS. IT IS OUR FIRST CASE OF THE DAY. THERE WAS NO PATIENT INJURY. IT WAS JUST A SLIGHT DELAY OF MAYBE 10 MINUTES TRYING TO GET ANOTHER PIECE OF EQUIPMENT. WE WENT ON WITH A STANDARD LAPAROSCOPIC L-HOOK AND CORD AND FOOT PEDAL, WHICH MOST OTHER DOCTORS USE AND WE ARE PROCEEDING WITH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300509 ↗
• MalfunctionApr 6, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, A DEVICE WAS USED TO MOBILIZE THE UTERUS WHEN ITS JAWS FAILED TO OPEN, CAUSING THE DEVICE TO BECOME STUCK ON TISSUE. THE JAWS WERE FORCED OPEN TO REMOVE THE DEVICE. WHILE TRYING TO GET THE JAWS OPEN, BLEEDING OCCURRED AT THE TISSUE THAT HAD BEEN CLAMPED. THE BLEEDING WAS QUICKLY RESOLVED BY USING A NEW DEVICE OF THE SAME TYPE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24790517 ↗
• MalfunctionMar 23, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS CLAMPED ONTO TISSUE AND BECAME STUCK. THE JAWS WERE LOCKED IN POSITION, THE DEVICE WAS REMOVED FROM THE TISSUE AND FROM SERVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662607 ↗
• MalfunctionJan 21, 2026Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO DEVICES' JAW LOCKED CLOSED. NEW DEVICE WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128075 ↗
• MalfunctionJan 6, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE, THE JAWS OF THE HANDPIECE WAS LOCKED ONTO THE TISSUE. SURGEON USED BOVIE AND LIGATURE TO REMOVE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973463 ↗
• MalfunctionDec 29, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A GYNECOLOGICAL PROCEDURE, THE JAWS OF THE FIRST LIGASURE DEVICE BROKE DURING USE AND THE INSTRUMENT WOULD NO LONGER OPERATE. A NEW DEVICE WAS OPENED AND IT WORKED FINE. ADDITIONALLY, WHEN A SECOND INSTRUMENT WAS OPENED, THE JAWS OF THE SECOND INSTRUMENT STOPPED OPENING WHILE IN USE AND THE INSTRUMENT COULD NO LONGER BE USED. A NEW DEVICE WAS OPENED AND IT WORKED FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904609 ↗
• MalfunctionDec 5, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT ROUGHLY 2 HOURS INTO A LAPAROSCOPIC LOW ANTERIOR RESECTION OF RECTUM, THE DEVICE¿S HANDLE WAS STUCK IN THE PULLED POSITION AND WAS DIFFICULT OR IMPOSSIBLE TO PULL AFTER SEALING AND CUTTING TISSUE AND COULD NOT BE UNLOCKED, MAKING THE JAWS DIFFICULT OR IMPOSSIBLE TO CLOSE OR OPEN. THE DEVICE WAS CLEAN SOME TIMES EVERY 20 MINUTES AS SOON AS ANY ESCHAR ON THE JAWS WAS NOTICED DEPENDED ON THE TISSUE BEING RESECTED. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THE DEVICE DID NOT GET STUCK ON TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725402 ↗
• MalfunctionSep 3, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE'S BASE SHAFT WHERE IT CONNECTS TO THE HANDLE WAS BROKEN WAS PHYSICALLY BROKEN BUT STILL ATTACHED AND NOTHING FELL ON THE PATIENT'S CAVITY. IT WAS NOTED THAT SIGNIFICANT TORQUE WAS BEING APPLIED TO THE DEVICE AT THE TIME THE SHAFT BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949575 ↗
• MalfunctionSep 2, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS INADEQUATE OR PARTIAL SEALING WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THE DEVICES WERE PLUGGED INTO AN FT10 GENERATOR WITH SOFTWARE VERSION 5.0.

  Patient problems: Insufficient Information

  MAUDE report 22937400 ↗
• MalfunctionSep 2, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING PROCEDURE; THERE WAS INADEQUATE OR PARTIAL SEALING WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THE DEVICES WERE PLUGGED INTO AN FT10 GENERATOR WITH SOFTWARE VERSION 5.0.

  Patient problems: Insufficient Information

  MAUDE report 22937273 ↗
• MalfunctionAug 22, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE; THE DEVICE¿S LOCKED AND WOULD NOT OPEN. THE JAW DID NOT GET STUCK ON TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870320 ↗
• MalfunctionJun 25, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SINGLE ANASTOMOSIS DUODENAL-ILEAL (SADI) PROCEDURE, THE PLASTIC PIECE OF THE HANDPIECE BROKE OFF. A NEW HANDPIECE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328563 ↗
• MalfunctionJun 9, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SEALING DEVICES, ABOUT 1 HOUR INTO THE SURGERY, THE JAWS OF THE TWO DEVICES GOT LOCKED CLOSE OR AT THE UTERINE VESSELS AND COULD NOT OPEN FOR SEALING AND EXCISING THE FALLOPIAN TUBE. THE DEVICES WERE DIFFICULT OR IMPOSSIBLE TO OPEN AND GOT STUCK ON TISSUE, WITH THE JAWS STUCK CLOSED. THE DEVICES SLIPPED OFF THE TISSUE AND WERE ABLE TO BE REMOVED WITH THE JAWS CLOSED. THE DEVICES DID NOT HAVE TO BE CLEANED AS THERE HAD BEEN NO BUILD-UP OF ESCHAR. THE KNIFE BLADES WERE NOT EXTENDED AND DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. THIS INCIDENT DID NOT CAUSE THE PROCEDURE TO BE EXTENDED BY MORE THAN 30 MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167602 ↗
• MalfunctionJun 9, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SEALING DEVICES, ABOUT 1 HOUR INTO THE SURGERY, THE JAWS OF THE TWO DEVICES GOT LOCKED CLOSE OR AT THE UTERINE VESSELS AND COULD NOT OPEN FOR SEALING AND EXCISING THE FALLOPIAN TUBE. THE DEVICES WERE DIFFICULT OR IMPOSSIBLE TO OPEN AND GOT STUCK ON TISSUE, WITH THE JAWS STUCK CLOSED. THE DEVICES SLIPPED OFF THE TISSUE AND WERE ABLE TO BE REMOVED WITH THE JAWS CLOSED. THE DEVICES DID NOT HAVE TO BE CLEANED AS THERE HAD BEEN NO BUILD-UP OF ESCHAR. THE KNIFE BLADES WERE NOT EXTENDED AND DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. THIS INCIDENT DID NOT CAUSE THE PROCEDURE TO BE EXTENDED BY MORE THAN 30 MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167533 ↗
• MalfunctionApr 18, 2025Electrical /Electronic Property Problem; Self-Activation or Keying; Electrical /Electronic Property Problem; Self-Activation or Keying

  IT WAS REPORTED THAT DURING LAP COLECTOMY, THE VALLEYLAB MODE OF THE DEVICE WOULD NOT STOP ACTIVATING WHILE BEING USED TO TAKE DOWN ADHESIONS. THE DEVICE WAS PLUGGED INTO AN FT10 GENERATOR AT THE TIME OF THE EVENT. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866215 ↗
• MalfunctionApr 3, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE WITH THE LIGASURE DEVICE, THERE WAS A JAW ISSUE WHERE THE JAW WOULD GET STUCK AND NOT FULLY OPEN. THE DEVICE WAS PLUGGED INTO A GENERATOR, SPECIFICALLY THE FT10 MODEL. 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 21760385 ↗
• MalfunctionMar 6, 2025Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DEVICE WAS NOT CLAMPED ON TISSUE WHEN IT MALFUNCTIONED DURING THE DISSECTION OF THE UTERUS. THE HANDLE BECAME STUCK IN THE PULLED POSITION, AND IN THE MIDDLE OF THE PROCEDURE, THE HANDLE STUCK IN THE CLOSED POSITION, CAUSING THE JAWS NOT TO OPEN BACK UP. IT DID NOT PROTRUDE 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 21534453 ↗
• MalfunctionDec 9, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING SEALING OF TISSUE, THERE WAS A GAP BETWEEN THE L-HOOK AND SIDE OF THE DEVICE'S JAW WAS WIDER THAN TYPICAL, WHICH CAUSED THE DEVICE TO SNAG ON TISSUE. ANOTHER DEVICE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20878621 ↗
• MalfunctionSep 23, 2024Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, THE KNIFE BLADE DID NOT RETRACT DURING MOBILIZATION. THE KNIFE BLADE WAS NOT EXPOSED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278889 ↗
• MalfunctionSep 23, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY, THE PATIENT WAS VERY LARGE AND DUE TO HIS SIZE, IT WAS DIFFICULT TO REACH, AND EXTREME ANGLES AND TORQUE WERE REQUIRED. THE SURGEON STATED THAT HE WAS APPLYING FORCES BEYOND WHAT THE DEVICE SHOULD BE EXPECTED TO HANDLE IN THIS PROCEDURE. UPON THIS TORQUE THE DEVICE SHAFT BROKE IN HALF DURING MOBILIZATION. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. NOTHING FELL ON THE PATIENT¿S CAVITY. THE SURGEON SPECIFICALLY STATED THIS WAS NOT A MALFUNCTION OR FAILURE OF THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278622 ↗
• MalfunctionSep 12, 2024Retraction Problem; Difficult to Open or Close; Retraction Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SIGMOID RESECTION, THE KNIFE BLADE WAS LOCKED AND WOULD NOT RELEASE DURING THE MOBILIZATION OF THE SIGMOID COLON. JAWS/HANDLE OF DEVICE WOULD NOT OPEN DESPITE TROUBLESHOOTING ATTEMPTS. SEALING AND CUTTING HAD BEEN COMPLETED SO SURGEON WAS ABLE TO REMOVE THE DEVICE FROM THE TISSUE (SIGMOID MESOCOLON AND SOME PERITONEUM). IT WAS CLEANED SEVERAL TIMES DURING THE CASE. A NEW HANDPIECE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201734 ↗
• MalfunctionAug 26, 2024Retraction Problem; Difficult to Open or Close; Intermittent Energy Output; Retraction Problem; Difficult to Open or Close; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC UNILATERAL, POSSIBLE BILATERAL SALPINGO-OOPHORECTOMY, FROZEN SECTION, POSSIBLE TOTAL LAPAROSCOPIC HYSTERECTOMY, THE KNIFE BLADE LEVER WAS STUCK IN THE PULLED POSITION AND NOT ABLE TO BE RELEASED TO OPEN THE JAWS OF THE HANDPIECE APPROXIMATELY 2 HOURS AFTER THE SURGERY STARTED. IT WAS LOCKED ON TISSUE, SPECIFICALLY A PEDICLE IN THE GYN SPACE LESS THAN 7MM IN THICKNESS. IT WAS REMOVED BY PULLING A SECOND HANDPIECE AND CUTTING THE TISSUE AROUND THE STUCK TISSUE TO REMOVE DEVICE. ADDITIONAL 20 MINUTES WAS ADDED TO PROCEDURE DUE TO A SECOND HANDPIECE HAD TO BE PULLED AND TO TROUBLESHOOT AND PROBLEM SOLVE WHAT THE FIRST HANDPIECE COULD NOT DO DUE TO THE FACT THAT IT LOCKED ON TISSUE. THE KNIFE BLADE WAS NOT PROTRUDING BEYOND THE EDGE OF THE JAWS. THERE WAS MINIMAL BLOOD LOSS BUT NO TRANSFUSION WAS NECESSARY.

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

  MAUDE report 20066105 ↗
• MalfunctionJul 9, 2024Activation, Positioning or Separation Problem; Difficult to Open or Close; Activation, Positioning or Separation Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF LAPAROSCOPIC HYSTERECTOMY FOR BROAD LIGAMENT, THE SURGEON REPORTED THAT BOTH RETRACTABLE L-HOOKS WERE NOT FUNCTIONING CORRECTLY. IT WOULD NOT EXTEND AND THEN RETRACT AS INDICATED. THERE WAS NO ACTIVATION OF TISSUE, NO TISSUE DAMAGE AND THE DEVICE WAS NEVER CLEANED. THE KNIFE BLADE DID NOT EXTEND NOR PROTRUDE BEYOND THE EDGE OF THE JAWS. IT WAS CONNECTED TO A GENERATOR WITH SOFTWARE VERSION 4.0.4. THE THIRD HANDPIECE TRIED TO WORK WITHOUT ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702457 ↗