LigaSure LF5637Recalls & reported problems

Summary

The FDA's MAUDE database contains 525 adverse event reports that list this exact device (DI 10884521521735), received between Jul 18, 2017 and Sep 29, 2026 — classified as 2 deaths, 29 injuries, 493 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (175 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 525 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941287 ↗
• MalfunctionSep 11, 2026Difficult to Open or Close

  It was reported that during the early part of a laparoscopic hysterectomy, the device Retractable L Hook was plugged into a generator and, while closing on a structure, the jaws became stuck and would not open. The jaws were eventually opened. It was replaced with a new LigaSure device Retractable L Hook, which was used to complete the procedure without issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728259 ↗
• MalfunctionSep 8, 2026Retraction Problem; Difficult to Open or Close; Intermittent Energy Output

  Patient problems: Tissue Breakdown

  MAUDE report 50671248 ↗
• MalfunctionJul 31, 2026Peeled/Delaminated; Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50100625 ↗
• MalfunctionMay 8, 2026Electrical /Electronic Property Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING DIAGNOSTIC LAPAROSCOPY, ABLATION OF ENDOMETRIOSIS, THE DEVICE DID NOT APPEAR TO HAVE ANY PROBLEMS, HOWEVER, ONCE THE HOOK WAS DEPLOYED TO INITIALLY OFF PELVIC WALL, IT WOULD NOT RETRACT FULLY, LEAVING IT PARTIALLY DEPLOYED WHILE USING THE SEALER. THE SEALER THEN DID NOT SEAL PROPERLY AS IF NOT ENOUGH CURRENT WAS BEING APPLIED. THE DEVICE WAS CLEANED AS NEEDED. THE MARYLAND WAS ABLE TO DEPLOY AND RETRACT PROPERLY. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT OPENING A NEW DEVICE. THE GENERATOR WAS USED WITHOUT INCIDENT IN THE PREVIOUS SURGERY AND THE SUBSEQUENT SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123783 ↗
• MalfunctionMar 30, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, SPECIFICALLY AT THE COLPOTOMY STEP, THE DEVICE WAS PLUGGED INTO A GENERATOR WITH SOFTWARE VERSION 5. THE SHAFT OF THE DEVICE WAS BROKEN AND DAMAGED, INCLUDING INSULATION DAMAGE AS THE JAWS OF THE INSTRUMENT TORE THROUGH THE L-HOOK SLEEVE. THE DEVICE DID NOT BREAK OFF DURING THE PROCEDURE, AND NO PIECES FULLY DETACHED OR FELL OFF. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729581 ↗
• MalfunctionMar 24, 2026Peeled/Delaminated; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) USING THE LIGASURE DEVICE, THE JAWS OF THE HANDPIECE WOULD NOT CLOSE. IT WAS NOTED THAT POSSIBLE EXCESSIVE TENSION MAY HAVE BEEN APPLIED TO THE DEVICE JAWS. THE DEVICE WAS BEING APPLIED TO THE UTERINE RESECTION AT THE TIME OF THE ISSUE. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A CRACK WAS NOTED ON THE SHAFT OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678386 ↗
• MalfunctionMar 19, 2026Break; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE HANDLE OF THE DEVICE BROKE WHILE ATTEMPTING TO USE THE DEVICE IN A LESS THAN 7MM UTERINE TISSUES/ARTERIES. THE DEVICE WAS PLUGGED INTO A GENERATOR AND ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. NO PART OF THE DEVICE DISENGAGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DEVICE'S JAW WAS DAMAGED. PIECES OF THE JAW OVERMOLD WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638214 ↗
• MalfunctionMar 16, 2026Melted; Peeled/Delaminated

  IT WAS REPORTED THAT DURING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE DEVICE¿S INSULATION TIP WAS PARTIALLY MELTED DURING AMPUTATION OF THE VAGINAL CUFF. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. NO BROKEN PIECE FELL INTO THE PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605481 ↗
• InjuryMar 16, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DEVICE HAD INADEQUATE OR PARTIAL, AS THERE WAS NO REGRASP BUT WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. PATIENT HAD EXCESSIVE AND SEVERE BLOOD LOSS AFTER CUTTING OCCURRED FROM THE VAGINAL VESSELS DURING THE TAKEDOWN OF VAGINAL VESSELS AND CUTTING OF THE VAGINAL CUFF. THE JAWS OF THE DEVICE WERE CLEANED TWICE DURING THE PROCEDURE. NO IMAGING WAS PERFORMED. THE PROCEDURE WAS EXTENDED BY 10-20 MINUTES DUE TO THE NEED FOR ADDITIONAL INTERVENTIONS, INCLUDING PLACEMENT OF ADDITIONAL SUTURES, RE-CAUTERIZATION, AND RE-SCRUBBING DURING THE PROCEDURE. THE TISSUE BEING SEALED WAS APPROXIMATELY 5MM THICK AND INVOLVED UTERINE VESSELS, SMALLER VESSELS WERE SEALED SUCCESSFULLY BUT ISSUES AROSE WITH LARGER VESSELS. NO BLOOD TRANSFUSION WAS NECESSARY OR DONE TO PATIENT DUE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24604631 ↗
• MalfunctionFeb 16, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE SHAFT OF THE HANDPIECE BROKE AT THE POINT OF CONNECTION TO THE HANDLE WHEN THE SURGEON PUT IT THROUGH THE LAPAROSCOPIC TROCAR. THERE WAS NO DETACHED PART NOTED. ANOTHER HANDPIECE 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 24344520 ↗
• MalfunctionFeb 15, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE¿S SEALING WAS INADEQUATE OR PARTIAL, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341701 ↗
• MalfunctionFeb 13, 2026Energy Output Problem; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE DEVICE, IT WORKED INTERMITTENTLY AND EXHIBITED INADEQUATE OR PARTIAL SEALING, WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THE DEVICE WAS PLUGGED INTO A GENERATOR, AND THE TISSUE TYPE BEING SEALED WAS BOWEL MESENTERY. THE JAWS WERE CLEANED REGULARLY DURING THE PROCEDURE. ANOTHER DEVICE OF THE SAME MODEL WAS USED SUCCESSFULLY WITH THE GENERATOR AFTER THE INITIAL DEVICE WAS REPLACED, AND NO FURTHER ISSUES OCCURRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334833 ↗
• MalfunctionFeb 2, 2026Retraction Problem; Connection Problem; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE WAS USED TO SEAL THE UTERINE ARTERIES WHEN SEVERAL ISSUES WERE IDENTIFIED. AFTER MULTIPLE COMPLETE SEALS, THE KNIFE TRIGGER BECAME STUCK IN THE PULLED POSITION AND THE TRIGGER STUCK ON THE UTERINE ARTERIES. THE DEVICE JAW WAS DIFFICULT OR IMPOSSIBLE TO OPEN, RESULTING IN THE DEVICE BECOMING STUCK ON TISSUE. THE DEVICE WAS CLEANED WITH WET GAUZE. THE KNIFE BLADE WAS EXTENDED, BUT IT DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. REMOVAL OF THE DEVICE REQUIRED RESECTION OF THE SURROUNDING TISSUE. ADDITIONALLY, THE DEVICE WAS NOT RECOGNIZED BY THE GENERATOR, DISPLAYING THE ERROR MESSAGE "INSTRUMENT NOT RECOGNIZED" IMMEDIATELY AFTER CONNECTION. THIS INCIDENT DID NOT CAUSE THE PROCEDURE TO BE EXTENDED BY MORE THAN 30 MINUTES. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR.

  Patient problems: Tissue Breakdown

  MAUDE report 24235151 ↗
• MalfunctionFeb 2, 2026Retraction Problem; Connection Problem; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE WAS USED TO SEAL THE UTERINE ARTERIES WHEN SEVERAL ISSUES WERE IDENTIFIED. AFTER MULTIPLE COMPLETE SEALS, THE KNIFE TRIGGER BECAME STUCK IN THE PULLED POSITION AND THE TRIGGER STUCK ON THE UTERINE ARTERIES. THE DEVICE JAW WAS DIFFICULT OR IMPOSSIBLE TO OPEN, RESULTING IN THE DEVICE BECOMING STUCK ON TISSUE. THE DEVICE WAS CLEANED WITH WET GAUZE. THE KNIFE BLADE WAS EXTENDED, BUT IT DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. REMOVAL OF THE DEVICE REQUIRED RESECTION OF THE SURROUNDING TISSUE. ADDITIONALLY, THE DEVICE WAS NOT RECOGNIZED BY THE GENERATOR, DISPLAYING THE ERROR MESSAGE "INSTRUMENT NOT RECOGNIZED" IMMEDIATELY AFTER CONNECTION. THIS INCIDENT DID NOT CAUSE THE PROCEDURE TO BE EXTENDED BY MORE THAN 30 MINUTES. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR.

  Patient problems: Tissue Breakdown

  MAUDE report 24234647 ↗
• MalfunctionJan 29, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, SPLIT INSULATION WAS OBSERVED ON THE DEVICE AND A HOLE WAS CAUSED IN THE GASTRIC ARTERY BY THE ENDO SHEARS. AN INSULATION ISSUE WAS ALSO IDENTIFIED WITH THE RETRACTABLE L HOOK, WHERE INSULATION FELL OFF OR DETACHED FROM THE SHAFT WHILE THE DEVICE WAS PLUGGED INTO A GENERATOR. ANOTHER LIGASURE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THE PATIENT EXPERIENCED A TEMPORARY INJURY AS A RESULT OF THE HOLE IN THE GASTRIC ARTERY, WHICH WAS MEDICALLY MANAGED BY CLIPPING THE ARTERY.

  Patient problems: Tissue Breakdown

  MAUDE report 24207337 ↗
• MalfunctionJan 8, 2026Peeled/Delaminated; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A SIGMOIDEUM RESECTION AFTER 2 HOURS AND 25 MIN, THE DEVICE HAD A BROKEN/DAMAGED SHAFT. NO PIECE OF THE DEVICE WAS DETACHED AND ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007042 ↗
• MalfunctionJan 7, 2026Retraction Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE¿S KNIFE BLADE COULD NOT RETRACT AND THE KNIFE BLADE EXTENDED BUT DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990620 ↗
• MalfunctionDec 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN OPEN HYSTERECTOMY PROCEDURE, BEFORE USING ON THE TISSUE, THE DEVICE WAS DIFFICULT OR IMPOSSIBLE TO OPEN. THE DEVICE WAS PLUGGED INTO A GENERATOR, AND 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 23877863 ↗
• MalfunctionDec 1, 2025Retraction Problem; Difficult to Open or Close; Intermittent Energy Output; Retraction Problem; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED APPROXIMATELY TWENTY-FIVE MINUTES INTO THE SURGERY, THE SHAFT OF THE INSTRUMENT BECAME STUCK ON A VESSEL AND TISSUE BUNDLE AND THE KNIFE BLADE COULD NOT RETRACT. THE DEVICE WAS PLUGGED INTO A GENERATOR AND THE SURGEON WAS ULTIMATELY ABLE TO OPEN THE INSTRUMENT. THE KNIFE WAS EXTENDED TO APPROXIMATELY THE MIDDLE OF THE SHAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER INSTRUMENT DEVICE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681844 ↗
• MalfunctionDec 1, 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 USING THE DEVICE, A JAW ISSUE OCCURRED IN THE EARLY VESSEL SEALING STEP. THE HANDPIECE WAS NOT CLEANED AS THE ISSUE HAPPENED AFTER APPROXIMATELY THREE TO FOUR ACTIVATIONS, THE JAWS OF THE DEVICE WOULD NOT OPEN, ALTHOUGH THE SURGEON WAS NOT ON TISSUE AT THE TIME. THE KNIFE BLADE WAS NOT EXTENDED NOR PROTRUDED BEYOND THE EDGE OF THE JAWS. THE DEVICE WAS PLUGGED INTO A GENERATOR, AND ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR, INDICATING THE ISSUE WAS NOT RELATED TO THE GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681197 ↗
• MalfunctionNov 21, 2025Peeled/Delaminated; Activation, Positioning or Separation Problem; Peeled/Delaminated; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BUTTON TO SHIFT FROM LIGASURE TO MONOPOLAR HOOK, DID NOT WORK PROPERLY. THE DEVICE WAS CONNECTED TO AN FT10 GENERATOR WITH SOFTWARE VERSION 5.0. A NEW LIGASURE DEVICE WAS CONNECTED AND IT WORKED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE SHAFT HAD SLIGHTLY CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617626 ↗
• MalfunctionNov 11, 2025Peeled/Delaminated; Activation, Positioning or Separation Problem; Peeled/Delaminated; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY (LAVH) PROCEDURE, THE LIGASURE LF5637 RETRACTABLE L HOOK EXPERIENCED A COMPONENT ISSUE IN WHICH THE MARYLAND TIP WOULD NOT DEPLOY. THEY USED ANOTHER HANDPIECE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE SHAFT OF THE DEVICE IS DAMAGED, NO PIECES ARE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520480 ↗
• MalfunctionNov 10, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING USE OF THE LIGASURE LF5637 RETRACTABLE L HOOK, THE JAWS BECAME STUCK TOGETHER AND THE HANDLE WAS STUCK IN THE PULLED POSITION. A NEW DEVICE WAS OPENED AND USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY, NO CONSEQUENCES OR IMPACT TO THE PATIENT AND NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509878 ↗
• MalfunctionOct 28, 2025Mechanical Problem; Peeled/Delaminated; Mechanical Problem; Peeled/Delaminated

  IT WAS REPORTED THAT DURING PROCEDURE, THE KNIFE BLADE COULD NOT ADVANCE. THE DEVICE WAS PLUGGED INTO A GENERATOR AT THE TIME OF THE EVENT, AND ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE SHAFT WAS DAMAGED, BUT NO PIECES WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404412 ↗