LigaSure LF1212A (UDI 10884521744189)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521744189), received between Aug 29, 2018 and Sep 24, 2026 — classified as 5 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (18 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892304 ↗
• MalfunctionDec 26, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING AN OPEN PROCEDURE, THE DEVICE FAILED TO SEAL TISSUE WITH NO EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR.

  Patient problems: Insufficient Information

  MAUDE report 23894974 ↗
• MalfunctionNov 4, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD NO SEAL WITH NO EVIDENCE OF ENERGY DELIVERY, END TONES WERE HEARD, AND NO RE-GRASP ALERT OR OTHER ERROR OCCURRED. CLEANING OF THE JAWS WERE NOT FREQUENT AND NO GOOD SEALS WERE COMPLETED BEFORE THE PROBLEM OCCURRED. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THE GENERATOR WAS CHECKED BY AN ENGINEER AND FOUND TO BE FUNCTIONING PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465712 ↗
• InjuryOct 19, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A THYROIDECTOMY, THE DEVICE DID NOT PERFORM ADEQUATE HEMOSTASIS ON THE CERVICAL VESSELS. THE SEAL WAS BREAKING AS THERE WAS NO REGRASP ALERT BUT THERE WAS ENERGY DELIVERY AFTER GOOD SEALS WERE COMPLETED IN SOME FENCES. THE DEVICE WAS CLEANED FOR ABOUT FIVE TIME. ANOTHER LIGASURE DEVICE USED SUCCESSFULLY WITH THE SAME GENERATOR TO STOP THE BLEEDING. PATIENT HAD HEAVY BLEEDING BUT NO BLOOD TRANSFUSION NECESSARY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23333953 ↗
• InjuryAug 25, 2025Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  ACCORDING TO THE REPORTER AFTER HEMORRHOIDECTOMY PROCEDURE, SEALING WAS INADEQUATE/PARTIAL (WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD). SEAL CYCLE ERRORS WERE ALSO NOTED. THE ISSUE LED TO SEVERE BLEEDING TO THE PATIENT ON MULTIPLE LOCATIONS OF THE BODY. SUTURING WAS DONE TO STOP THE BLEEDING AND HOSPITALIZATION WAS EXTENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22888895 ↗
• InjuryAug 25, 2025Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  ACCORDING TO THE REPORTER AFTER HEMORRHOIDECTOMY PROCEDURE, SEALING WAS INADEQUATE/PARTIAL (WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD). SEAL CYCLE ERRORS WERE ALSO NOTED. THE ISSUE LED TO SEVERE BLEEDING TO THE PATIENT ON MULTIPLE LOCATIONS OF THE BODY. SUTURING WAS DONE TO STOP THE BLEEDING AND HOSPITALIZATION WAS EXTENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22887949 ↗
• MalfunctionJun 16, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY PROCEDURE, THE DEVICE HAD PARTIAL SEALING. THERE WAS EVIDENCE OF ENERGY DELIVERY, NO RE-GRASP ALERT, AND END TONES WERE HEARD. THERE WAS BLEEDING BUT BLOOD TRANSFUSION WAS NOT NECESSARY. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THIS GENERATOR. THE TISSUE WAS THIN TO MEDIUM THICKNESS. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213366 ↗
• MalfunctionSep 5, 2024Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY, THE DEVICE HAD SEALING INADEQUATE/PARTIAL (WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD) AFTER 3 TO 5 GOOD SEALS. THE INPUT FAILED TO CAUTERIZE TISSUE. THE CONSOLE WAS CHECKED AND FOUND TO BE OPERATIONAL. THE DEVICE WAS CLEANED EVERY TIME IT WAS USED. ANOTHER LIGASURE DEVICE USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153759 ↗
• MalfunctionJul 9, 2024Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, THE LIGASURE DEVICE WOULD CUT AND CAUTERIZE THE TARGET TISSUES, BUT THE NON-TARGET TISSUE WOULD GET STUCK TO THE CAUTERY JAWS AND AT THE BASE OF THE JAWS. THIS WOULD CAUSE THE NON-TARGET TISSUE TO RIP AND TEAR AND BLED.

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

  MAUDE report 19704674 ↗
• MalfunctionJul 9, 2024Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING C-SECTION WITH BILATERAL SALPINGECTOMY, THE DEVICE WOULD CUT AND CAUTERIZE THE TARGET TISSUES, BUT THE JAWS AND AT THE BASE OF THE JAWS WOULD STICK TO THE ORIGINAL, INTACT UTERINE TISSUE CAUSING IT TO RIP/TEAR LEADING TO ADDITIONAL BLEEDING TO THE OPERATIVE SITES, IN ADDITION TO THE LOSS OF BLOOD FROM THE C-SECTION PROCEDURE. THE DEVICE DID NOT DO A GOOD, CLEAN CAUTERIZATION AND REMOVAL OF THE FALLOPIAN TISSUE. PROLONGED CARE PROVIDED TO THE PATIENT.

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

  MAUDE report 19704415 ↗
• MalfunctionFeb 2, 2024Energy Output Problem; Failure to Cut; Failure to Fire; Energy Output Problem; Failure to Cut; Failure to Fire

  ACCORDING TO THE REPORTER, DURING PARTIAL THYROIDECTOMY, AT THE BEGINNING OF SURGERY WHEN STARTED TO USE THE DEVICE, THE SURGEON SIG NALED THAT THE GRIPPER WAS NOT SEALING OR CUTTING. THE POWER WAS NOT BEING CONDUCTED EFFICIENTLY AND NEEDED TO BE REPLACED. NO RE-GRASP ALERT NOR END TONE WAS HEARD. THERE WAS BLEEDING ABOUT 50 MILLILITERS, NO BLOOD TRANSFUSION REQUIRED. THE TISSUE BUNDLE WAS ABOUT 5 MILLIMETERS THICK, MEDIUM FABRIC. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634101 ↗
• MalfunctionJan 26, 2024Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING C-SECTION ON A DOG, THE DEVICE ACTIVATION AND END TONE WERE HEARD BUT SEALING WAS INADEQUATE/PARTIAL. THE OVARIAN ARTERIES DID NOT SEAL AND RESULTED TO HEMORRHAGE. LOSS APPROXIMATELY 10% OF THE PATIENT¿S BLOOD VOLUME AND RECOVERED. LIGATIONS TO STOP BLEEDING WHERE LIGASURE FAILED. NO BLOOD TRANSFUSION WAS REQUIRED. BLEEDING WAS OBSERVED DIRECTLY FROM THE LIGASURE SEAL, THE VESSEL WAS FULLY TRANSECTED. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18588351 ↗
• MalfunctionDec 4, 2023Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL TUBAL LIGATION, THE DEVICE WOULD NOT CAUTERIZE. ACTIVATION TONE AND END TONE WERE HEARD. THERE WAS NO BLEEDING. SIX GOOD SEALS ON A 2MM THICK FALLOPIAN TUBE WERE COMPLETED BEFORE THE PROBLEM OCCURRED. USED SIMILAR DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263718 ↗
• MalfunctionOct 12, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY, THE CLAMP BROKE IN HALF. NO PARTS FELL INTO THE PATIENT. THE ARM WAS REPLACED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17924796 ↗
• MalfunctionSep 13, 2023Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING TUBAL LIGATION/SALPINGECTOMY PROCEDURE, THERE WAS STICKING OF TISSUE BETWEEN THE JAWS AFTER ACTIVATION. THE ONE DEVICE WAS USED FOR THE ENTIRE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741110 ↗
• MalfunctionMay 16, 2023Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING TOTAL ABDOMINAL HYSTERECTOMY, LIGASURE HAD NO SEAL. DEVICE STOPPED SEALING. USED OTHER DEVICE LIKE MONOPOLAR TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943010 ↗
• MalfunctionFeb 16, 2023Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE HANDPIECE DID NOT SEAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386713 ↗
• MalfunctionDec 1, 2022Device Alarm System; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ABNOMINAL EXPLORATION AND RNA, TWO HANDPIECES DID NOT ACTIVATE. DEVICES BROUGHT UP AN ERROR CODE, AND WOULD NOT CONTINUE. THE MACHINE WAS WORKING JUST FINE. DEVICE WAS UNPLUGGED AND PLUGGED BACK IN, AS WELL AS SHUT IT ALL DOWN AND TRIED AGAIN BUT THE HANDLES WERE NOT RESPONSIVE. SURGEON WAS USING THE HAND SWITCH. SURGEON TIED OFF THE VESSELS WITH SUTURE TO COMPLETE THE PROCEDURE. PATIENT HAD STABLE ANESTHESIA AND HAS BEEN DISCHARGED. THIS EVENT WAS USED IN VETERINARY CASE.

  Patient problems: Insufficient Information

  MAUDE report 15893884 ↗
• MalfunctionDec 1, 2022Device Alarm System; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ABDOMINAL EXPLORATION AND RNA, TWO HANDPIECES DID NOT ACTIVATE. DEVICES BROUGHT UP AN ERROR CODE, AND WOULD NOT CONTINUE. THE MACHINE WAS WORKING JUST FINE. DEVICE WAS UNPLUGGED AND PLUGGED BACK IN, AS WELL AS SHUT IT ALL DOWN AND TRIED AGAIN BUT THE HANDLES WERE NOT RESPONSIVE. SURGEON WAS USING THE HAND SWITCH. SURGEON TIED OFF THE VESSELS WITH SUTURE TO COMPLETE THE PROCEDURE. PATIENT HAD STABLE ANESTHESIA AND HAS BEEN DISCHARGED. THIS EVENT WAS USED IN VETERINARY CASE.

  Patient problems: Insufficient Information

  MAUDE report 15893544 ↗
• MalfunctionJun 28, 2022Mechanical Problem; Retraction Problem; Mechanical Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE MATERIAL WAS DEFECTIVE, THE DEVICE THAT TRIGGERS THE CUT AND THE KNIFE STOPPED AND DID NOT RETURN TO ITS ORIGINAL POSITION. IT WAS NECESSARY TO DISPENSE ANOTHER UNIT OF THE PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842748 ↗
• MalfunctionJun 20, 2022Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD SEAL ISSUE. THERE WAS NO REGRASP ALERT AND NO EVIDENCE OF ANY ENERGY DELIVERY BUT THERE WAS AN END TONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14747326 ↗
• MalfunctionDec 17, 2021Energy Output Problem; Failure to Cut; Intermittent Energy Output; Energy Output Problem; Failure to Cut; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT CUT AND DID NOT SEAL. THERE WAS NO REGRASP ALERT REPORTED. THE BIP WAS NOT HEARD AS SIGNALING THE END OF THE SEAL. THERE WAS AN EVIDENCE OF ENERGY DELIVERY. AFTER CONNECTING A NEW TWEEZER, THE DEVICE WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024994 ↗
• MalfunctionNov 2, 2021Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD SEAL ISSUE, IT WOULD NOT SEAL DESPITE MULTIPLE ATTEMPTS. THEY OPENED ANOTHER NEW DEVICE AND WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739097 ↗
• MalfunctionOct 22, 2021Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING THE INTRATHORACIC GOITER EXTIRPATION, THE DEVICE HAD NO SEAL. A MECHANICAL FAILURE WAS NOTED IN THE COAGULATION SCISSORS THAT WERE NOT SEALING THE VESSELS. IT WAS REPLACED BY NEW COAGULATION SCISSORS TO CONTINUE AND IT WORKED UNEVENTFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682427 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY, THE DEVICE HEATED THAT CAUSED PATIENT'S BURN. THERE WAS TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS. THEY CUT THAT PIECE OF SKIN OFF AND CLOSED THE INCISION NORMALLY. THE PICTURE ATTACHED SHOWED A DEEP BURN WOUND.

  Patient problems: Burn(s); Unspecified Tissue Injury

  MAUDE report 12097349 ↗