LigaSure LF3225 (UDI 10884521197183)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521197183), received between May 9, 2018 and Apr 6, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Retraction Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE'S KNIFE BLADE JAMMED AND COULD NOT RETRACT.

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

  MAUDE report 24790374 ↗
• MalfunctionApr 6, 2026Retraction Problem

  IT WAS REPORTED THAT DURING A VAGINAL HYSTERECTOMY PROCEDURE, THE DEVICE'S KNIFE BLADE JAMMED AND COULD NOT RETRACT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 24790243 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN SETTING UP THE DEVICE, THE DISPOSABLE WAS ATTACHED TO THE REUSABLE CLAMP IN THE PRESCRIBED MANNER, AND NO ISSUES OR ABNORMALITIES WERE NOTICED. HOWEVER, DURING A DEBULKING SURGERY, THE OPERATING TEAM NOTICED A GREY PIECE OF PLASTIC IN THE PATIENT¿S ABDOMEN. WHEN THE STAFF TOOK IT OUT OF THE PATIENT, INVESTIGATED AND FOUND OUT IT WAS ONE OF THE PINS OF THE DEVICE¿S INLAY. THE SURGEON DECIDED TO FINISH THE SURGERY WITH THE SAME DEVICE, SINCE THE PROCEDURE WERE CLOSE TO FINISH, AND IT DID SEEM TO STILL WORK PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873834 ↗
• MalfunctionOct 17, 2024Difficult to Open or Close; Protective Measures Problem; Difficult to Open or Close; Protective Measures Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT WAS UNABLE TO MOUNT/CLIP THE ELECTRODE TO SEAL THE OPEN DIVIDER ON THE LIGASURE CLAMP; THE BLADE WAS MORE OUT THAN USUAL. THE DEVICE WAS CONNECTED TO THE GENERATOR, AND THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER LIGASURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20470345 ↗
• MalfunctionJul 3, 2023Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE THE END OF THE DEVICE BROKE OFF ON APPLICATION AND WOULD NOT CONNECT TO THE HAND PIECE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246453 ↗
• MalfunctionJun 16, 2023Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, PRIOR TO A C SECTION, THE BLADE ON THE LEFT JAW OF LIGASURE WAS EXPOSED. UPON OPENING, IT APPEARED THAT WHOLE LEFT JAW WAS NOT PROPERLY CONNECTED TO LIGASURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142730 ↗
• MalfunctionFeb 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LIGASURE DISPOSABLE UNIT HAD A BLUE PLASTIC PIECE TO SECURE THE CABLE. WHEN THE SURGEON BROKE THIS OPEN ALONG THE PERFORATIONS, A VERY SMALL PIECE OF PLASTIC BROKE OFF INTO THE ABDOMEN. PHYSICIAN WAS ABLE TO FIND SMALL PIECE AND REMOVE FROM PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576900 ↗
• MalfunctionFeb 15, 2021Difficult to Open or Close; Separation Problem; Difficult to Open or Close; Separation Problem

  DURING THE PROCEDURE, AT THE BEGINNING OF THE PROCEDURE, THE JAWS OF THE DISSECTOR WERE PARTICULARLY ATTACHING TO THE TISSUE (TISSUE STICKING TO THE JAWS). AS A CONSEQUENCE, IT WAS DIFFICULT TO REOPEN THE JAWS AND CONTINUE WITH THE PROCEDURE. THERE WAS NO CONSEQUENCE FOR THE PATIENT, BUT IT INCREASED THE OPERATING TIME. ANOTHER DISSECTOR WAS USED WITHOUT ANY PROBLEM ENCOUNTERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327318 ↗
• MalfunctionJan 21, 2021Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, IT WAS IMPOSSIBLE TO RETRACT THE BLADE PREVENTING THE BUTTON FROM BEING USED.

  Patient problems: Insufficient Information

  MAUDE report 11207813 ↗
• MalfunctionOct 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL ABDOMINAL HYSTERECTOMY, ADHESIOLYSIS, CONSERVE OVARIES, PART OF THE DEVICE FELL OFF (NOT INTO THE PATIENT). THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10767210 ↗
• MalfunctionSep 15, 2020Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE KNIFE BLADE DID NOT RETRACT. THE SURGEON OPENED A NEW HAND PIECE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10538768 ↗
• MalfunctionAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL PROCEDURE, THE PATIENT HAD A FIRST-DEGREE BURN OUTSIDE THE VAGINA IN THE (B)(6) WITH THE DEVICE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 10469060 ↗
• MalfunctionAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL PROCEDURE, THE PATIENT HAD A FIRST DEGREE BURN OUTSIDE THE VAGINA IN THE LABIA MAJORA WITH THE DEVICE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 10452802 ↗
• MalfunctionAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL PROCEDURE, THE PATIENT HAD A FIRST-DEGREE BURN OUTSIDE THE VAGINA IN THE LABIA MAJORA WITH THE DEVICE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 10452795 ↗
• MalfunctionJul 23, 2020Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S KNIFE BLADE DID NOT RETRACT. IT WAS DISCOVERED THAT THE LEVER THAT OPERATES THE BLADE WAS BLOCKED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10315910 ↗
• MalfunctionJan 6, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, THE DEVICE HAD AN INCOMPLETE SEAL, THEY ADJUSTED IT AND RE-TRIED IT THREE TIMES, THEN THEY ABANDONED THE DEVICE AND USED A CAUTERY DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552666 ↗
• MalfunctionNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD A FIRST DEGREE VULVAR BURN.

  Patient problems: Burn(s)

  MAUDE report 8091896 ↗
• MalfunctionNov 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD A FIRST DEGREE VULVAR BURN.

  Patient problems: Burn(s)

  MAUDE report 8076046 ↗
• MalfunctionNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT GOT A FIRST DEGREE VULVAR BURN.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 8054662 ↗
• MalfunctionMay 9, 2018Flare or Flash; Flare or Flash

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT EXPERIENCE FIRST DEGREE BURN (REDNESS) AT THE VULVAR AREA.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 7499039 ↗