LigaSure LF1637Recalls & reported problems

Summary

The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 10884521147003), received between Jan 26, 2016 and Dec 12, 2022 — classified as 18 injuries, 187 malfunctions.

The most frequently reported specific device problem is “Energy Output To Patient Tissue Incorrect” (48 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 205 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2022Protective Measures Problem; Separation Problem; Protective Measures Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY, THE FIRST-TIME CLOSURE ADHESION WAS MORE SERIOUS, AND WHEN THE JAWS WERE OPENED, IT WAS INCIDENTALLY PULLED TO OTHER TISSUES AROUND THE PATIENT, THIS ISSUE HAD HAPPENED FOR BOTH DEVICES. TISSUE WAS NOT UNDER ANY TENSION. THE KNIFE BLADE WAS EXTENDED BUT IT DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. THE TISSUE WAS SLIGHTLY TORN AND BLEEDING IN LOCAL TISSUES AND THERE WAS NO NEED FOR BLOOD TRANSFUSION. THERE WAS A 30-MINUTE DELAY ON THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 15960765 ↗
• InjuryDec 9, 2022Protective Measures Problem; Separation Problem; Protective Measures Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRST-TIME CLOSURE ADHESION WAS MORE SERIOUS, AND WHEN THE JAWS WERE OPENED, IT WAS INCIDENTALLY PULLED TO OTHER TISSUES AROUND THE PATIENT. TISSUE WAS NOT UNDER ANY TENSION. THE KNIFE BLADE WAS EXTENDED BUT IT DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. THERE WAS A SMALL AMOUNT OF BLEEDING IN LOCAL TISSUES AND THERE WAS NO NEED FOR BLOOD TRANSFUSION. THERE WAS A 30-MINUTE DELAY ON THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 15953139 ↗
• MalfunctionJul 8, 2022Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL PROCEDURE, THE CLAMP WAS USED AND THE SITUATION OF ADHESION WAS SEVERE. THE DEVICE WAS LOCKED/STICKING ON TISSUE WHICH WAS NOT IN ANY TENSION AND WOULD PULL OTHER TISSUES AROUND THE PATIENT. THE DEVICE WAS REMOVED BY OPENING AND CLOSING THE JAWS MULTIPLE TIMES AND BY THE ASSISTANCE OF OTHER INSTRUMENTS. THERE WAS A SMALL AMOUNT OF BLEEDING BUT THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14961315 ↗
• MalfunctionMar 29, 2022Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD STICKING ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939551 ↗
• MalfunctionMar 10, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE JAW WAS UNABLE TO OPEN AND CLOSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721303 ↗
• MalfunctionMar 9, 2022Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE JAW OF THE DEVICE COULDN'T BE OPENED OR CLOSED REPEATEDLY AS IT DID NOT ACTIVATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711483 ↗
• MalfunctionSep 27, 2021Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL HYSTERECTOMY PROCEDURE, THE DEVICE HAD A JAW ISSUE - TISSUE STICKING. THE PROCEDURE WAS COMPLETED BY USING A NON-MEDTRONIC HANDPIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532792 ↗
• MalfunctionFeb 25, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, HAND PIECE JAW WAS DIFFICULT TO OPEN. THE JAWS WERE PARTIALLY OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377902 ↗
• InjuryJan 12, 2021Energy Output Problem; Difficult or Delayed Activation; Intermittent Energy Output; Energy Output Problem; Difficult or Delayed Activation; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY, WHEN THE SURGEON PERFORMED TISSUE DISSECTION THE HANDLE FIRST WORK PROPERLY, THEN AFTER 5 MINUTES THE SEALING CYCLE WERE NOT COMPLETE THERE WAS A REGRASP ALARM. WHEN THE SURGEON ACTIVATE AND FINISH THE SEALING THE TISSUE BLEED AND THE SEALING WERE NOT PERFORMED CORRECTLY. THE SURGEON NEED TO ACTIVATE MORE THAN THREE TIMES TO GET THE RIGHT SEALING WITHOUT BLEEDING. THE SURGEON OPEN SECOND HANDLE AND THE PROBLEM WAS SAME. A THIRD NEW SIMILAR DEVICE WAS OPENED TO SOLVE THE ISSUE. THERE WAS EXTENSION OF SURGICAL TIME OF MORE THAN 30 MINUTES WHICH PATIENT HAD UNANTICIPATED TISSUE LOSS. PATIENT HAD EXTENDED HOSPITALIZATION. THERE WAS A MINOR BLEEDING.

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

  MAUDE report 11153931 ↗
• InjuryJan 12, 2021Energy Output Problem; Difficult or Delayed Activation; Intermittent Energy Output; Energy Output Problem; Difficult or Delayed Activation; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY, WHEN THE SURGEON PERFORMED TISSUE DISSECTION THE HANDLE FIRST WORK PROPERLY, THEN AFTER 5 MINUTES THE SEALING CYCLE WERE NOT COMPLETE THERE WAS A REGRASP ALARM. WHEN THE SURGEON ACTIVATE AND FINISH THE SEALING THE TISSUE BLEED AND THE SEALING WERE NOT PERFORMED CORRECTLY. THE SURGEON NEED TO ACTIVATE MORE THAN THREE TIMES TO GET THE RIGHT SEALING WITHOUT BLEEDING. THE SURGEON OPEN SECOND HANDLE AND THE PROBLEM WAS SAME. A THIRD NEW SIMILAR DEVICE WAS OPENED TO SOLVE THE ISSUE. THERE WAS EXTENSION OF SURGICAL TIME OF MORE THAN 30 MINUTES WHICH PATIENT HAD UNANTICIPATED TISSUE LOSS. PATIENT HAD EXTENDED HOSPITALIZATION. THERE WAS A MINOR BLEEDING.

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

  MAUDE report 11153918 ↗
• MalfunctionJan 11, 2021Smoking; Protective Measures Problem; Smoking; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WAS SMOKING AND THERE WAS A BLADE IN THE TIP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11146382 ↗
• MalfunctionDec 29, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIPS OF THE DEVICE WOULD STICK TO THE TISSUE WHEN IN USE. THE LIGASURE DEVICE WAS STILL USED DURING THE CASE BUT BECAME AN ANNOYANCE TO THE SURGEON WHILE OPERATING. ISSUE WAS ISOLATED TO LIGASURE BECAUSE SAME GENERATOR WAS USED FOR OTHER CASES WITHOUT SIMILAR REPORTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11087034 ↗
• MalfunctionOct 31, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY PROCEDURE, THE SURGEON EXPERIENCED EXCESSIVE STICKING OF BURNT TISSUE TO THE JAWS. THE SURGEON THEN USED ANOTHER DEVICE'S HANDPIECE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10767434 ↗
• MalfunctionOct 31, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE JAW LOCKED DUE TO A CALCIFIED TISSUE IN JAW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10767430 ↗
• MalfunctionOct 31, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THERE WAS EXCESSIVE STICKING OF THE TISSUE TO DEVICE'S JAWS. THE DEVICE WAS REMOVED BY PULLING IT AWAY FROM THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A MINIMAL BLEEDING LESS THAN 250CC BUT NO TISSUE RESECTION AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10767205 ↗
• MalfunctionOct 16, 2020Energy Output Problem; Separation Problem; Energy Output Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHEN ACTIVATING ENERGY USING THE LIGASURE DEVICE, IT WAS NOTICED THAT AFTER REACHING END TONES TO COMPLETE SEAL CYCLE AND CUTTING, IT WAS REPORTED THAT THE TISSUE DID NOT LOOK FULLY SEALED AND LOOKED RAW WHERE THERE WAS SOME BLEEDING AND THE TISSUE WAS STICKING TO THE JAWS OF THE DEVICE. THE DEVICE DID NOT LOCKED ON TISSUE. THE BLEEDING WAS LESS THAN 250CC. IT WAS ALSO REPORTED DURING THE SAME CASE THAT THE MONOPOLAR CAUTERY PENCIL WHILE USING A LAPAROSCOPIC L-HOOK WAS NOT GENERATING A SUFFICIENT ENERGY EFFECT WHILE MAKING GOOD CONTACT WITH TISSUE. THE GENERATOR WAS SWITCHED OUT DURING THE CASE AND THE LIGASURE DEVICE WAS SWITCHED TO ANOTHER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO MONOPOLAR ISSUES WITH THE NEW GENERATOR, THE NEW LIGASURE DEVICE WORKED PROPERLY ON THE NEW GENERATOR. THERE WAS NO PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10688786 ↗
• MalfunctionSep 3, 2020Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE KNIFE BLADE DID NOT RETRACT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 10488665 ↗
• MalfunctionAug 27, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  DEVICE WAS RETURNED WITHOUT ANY ACCOMPANYING COMPLAINT INFORMATION. INITIAL VISUAL INSPECTION FOUND THE BLACK ROD INSULATION OF THE DEVICE WAS DAMAGED AND DISENGAGED. THE DISENGAGED INSULATION WAS RETURNED.

  Patient problems: No Information

  MAUDE report 10459637 ↗
• MalfunctionMay 20, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING MYOMECTOMY, THE JAWS OF THE DEVICE WERE STICKING WITH THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO TISSUE DAMAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10074076 ↗
• MalfunctionMay 12, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING MYOMECTOMY, THE JAWS OF THE DEVICE WERE STICKING WITH THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO TISSUE DAMAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10047727 ↗
• MalfunctionMay 12, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING MYOMECTOMY, THE JAWS OF THE DEVICE WERE STICKING WITH THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO TISSUE DAMAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10047697 ↗
• MalfunctionApr 21, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING A RIGHT HEMICOLECTOMY, THE LIGASURE HANDPIECE HAD A TISSUE STICKING ISSUE. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. FURTHER INFORMATION IS UNAVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9980626 ↗
• MalfunctionApr 13, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, THERE WAS TISSUE STICKING ISSUE. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INVESTIGATION FOUND THAT THE JAWS OF THE DEVICE WERE STUCK TO THE TISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9952752 ↗
• MalfunctionMar 30, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE TIP WAS NOT OPENING AND THE HANDLE WAS STUCK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9899218 ↗
• MalfunctionFeb 27, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID PARTIAL SEAL AND THE END TONE WAS HEARD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763202 ↗