LigaSure Impact LF4418Recalls & reported problems

Summary

The FDA's MAUDE database contains 325 adverse event reports that list this exact device (DI 10884521612525), received between Jun 26, 2017 and Sep 30, 2026 — classified as 3 deaths, 14 injuries, 308 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (109 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 325 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Alarm System; Energy Output Problem

  It was reported that during a procedure, the device had error code and energy activation/sealing issue. Another LigaSure device was used successfully with the same generator. The surgical procedure was extended by 10 minutes.

  Patient problems: Insufficient Information

  MAUDE report 50941641 ↗
• MalfunctionSep 24, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886574 ↗
• MalfunctionSep 24, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885219 ↗
• MalfunctionSep 17, 2026Failure to Sense

  Ligasure Impact Handpiece was not recognized by the generator when plugged in.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802110 ↗
• MalfunctionSep 11, 2026Difficult to Open or Close

  It was reported that, during a right trisegmentectomy, the handpiece was being used and the handle would not release while being used unless manually done by the surgeon. A new device was opened to be used.There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727028 ↗
• MalfunctionSep 8, 2026Protective Measures Problem

  It was reported that during a procedure, the device¿s blade was exposed and got stuck in the blade head. The surgery was interrupted because the blade was exposed and a new instrument was replaced. There was no patient injury. Photographs were received and showed that the knife blade sticking out of the jaw.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669049 ↗
• MalfunctionSep 2, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565814 ↗
• MalfunctionAug 25, 2026Difficult to Open or Close

  It was reported that during a procedure with a use of the device, the jaw failed to open properly and the device was difficult or impossible to open. The instrument was replaced with a new product to complete the surgery. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436543 ↗
• MalfunctionAug 3, 2026Mechanical Problem; Peeled/Delaminated; Failure to Cut; Difficult to Open or Close; Material Twisted/Bent; Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50116190 ↗
• MalfunctionMay 27, 2026Difficult to Open or Close

  IT WAS REPORTED THAT APPROXIMATELY 5 MINUTES INTO THE ABOVE KNEE AMPUTATION PROCEDURE, THE DEVICE¿S PULL HANDLE BECAME STUCK AND WOULD NOT OPEN. THE KNIFE BLADE WAS NOT EXTENDED NOR PROTRUDED. ANOTHER DEVICE WAS THEN USED SUCCESSFULLY WITH THE SAME GENERATOR TO COMPLETE THE OPERATION. IT WAS NOTED THAT THE ISSUE HAPPENED OUTSIDE THE PATIENT. NO CLEANING OF THE DEVICE WAS DONE AS IT HAPPENED 5 MINUTES INTO THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296244 ↗
• MalfunctionMay 5, 2026Energy Output Problem

  IT WAS REPORTED THAT, DURING AN EXPLORATORY LAPAROTOMY AND OPEN DISTAL PANCREATECTOMY (MODIFIER -22 GIVEN THE LARGE TUMOR, INFILTRATIVE NATURE OF THE TUMOR, SIGNIFICANT PANCREATITIS, AND UPPER ABDOMINAL VARICES), WITH EN BLOC SPLENECTOMY, EN BLOC LEFT ADRENAL GLAND RESECTION WITH A PORTION OF GEROTA¿S FASCIA, PARTIAL OMENTECTOMY WITH OMENTAL MASS EXCISION MEASURING 2 CM IN SIZE, PERIPANCREATIC MASS EXCISION MEASURING 3 CM IN SIZE, PANCREAS ULTRASOUND, OMENTAL FLAP CREATION AND PLACEMENT, AND PERIPANCREATIC LYMPHADENECTOMY, THE DEVICE DID NOT SEAL PROPERLY TO CAUTERIZE TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 25082636 ↗
• MalfunctionApr 28, 2026Retraction Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING USE WHEN HANDLE ENGAGED, THE BLADE REMAINED DEPLOYED AND EXPOSED. 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 25011448 ↗
• MalfunctionApr 28, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN CLOSING THE HANDLE AND THEN PUSHING THE HANDLE AGAIN TO OPEN, THE HANDLE DID NOT FLEX OUT OPEN, STUCK IN PULLED POSITION AND STAYED IN CLOSED POSITION WHEN APPLIED TO COLON. THE DEVICE DID NOT GET TOTALLY STUCK IN CLOSED POSITION SO IT WAS ABLE TO REMOVE IT. THE DEVICE'S KNIFE DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. ANOTHER LIGASURE DEVICE USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25011378 ↗
• MalfunctionApr 27, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE¿S HANDLE BECAME STUCK IN THE PULLED POSITION WHEN CLOSING THE HANDLE AND THEN PUSHING THE HANDLE AGAIN TO OPEN. THE HANDLE DID NOT FLEX OUT OPEN, IT STAYED IN CLOSED POSITION. THE DEVICE WAS APPLIED TO COLON BUT DID NOT GET TOTALLY STUCK IN CLOSED POSITION SO IT WAS ABLE TO REMOVE IT. THE DEVICE'S KNIFE DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24995630 ↗
• MalfunctionApr 9, 2026

  LIGASURE IMPACT WOULD NOT SEAL PROPERLY TO CAUTERIZE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24828490 ↗
• MalfunctionApr 6, 2026Mechanical Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN OPEN PROCEDURE, THE DEVICE WAS PLUGGED INTO A GENERATOR WHEN THE LEVER ON THE HANDLE WAS NOTED TO STICK AND WAS SLIGHTLY DIFFICULT TO RELEASE. A SECOND LIGASURE DEVICE WAS ALSO USED AND EXHIBITED SIMILAR ISSUES WITH THE LEVER MECHANISM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794092 ↗
• MalfunctionApr 1, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER PRIOR TO USE, THE PURPLE COMPONENT ON THE DEVICE PLUG FRACTURED AND DETACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755215 ↗
• MalfunctionApr 1, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE DEVICE WAS DIFFICULT/IMPOSSIBLE TO OPEN. THE JAWS WERE LOCKING UP. GOT A NEW ONE A ND HAD THE SAME PROBLEM, BUT IT DID NOT LOCK UP AS BADLY. THE DEVICE DID NOT GET STUCK ON TISSUE. THE DEVICE WAS CLEANED WHEN IT WAS DIRTY. THE KNIFE BLADE WAS NOT EXTENDED AND DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. ANOTHER LIGASURE 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 24751454 ↗
• MalfunctionMar 24, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING USE, THE DEVICE WAS DIFFICULT TO CLOSE DUE TO A JAW ISSUE AND THE DEVICE TIP WAS DIFFICULT TO OPEN. THE DEVICE WAS PLUGGED INTO A GENERATOR AT THE TIME OF THE EVENT, AND ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673944 ↗
• MalfunctionMar 24, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING USE, THE DEVICE WAS DIFFICULT TO CLOSE DUE TO A JAW ISSUE AND THE DEVICE TIP WAS DIFFICULT TO OPEN. THE DEVICE WAS PLUGGED INTO A GENERATOR AT THE TIME OF THE EVENT, AND ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673900 ↗
• MalfunctionMar 16, 2026Energy Output Problem; Failure to Cut; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE USE OF THREE DEVICES, THE DEVICES DID NOT CUT AND NO SEAL WAS ACHIEVED. THERE WAS NO EVIDENCE OF ENERGY DELIVERY, AND NO END TONES WERE HEARD. THE DEVICES WERE PLUGGED INTO A GENERATOR AT THE TIME OF THE EVENT, AND ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608190 ↗
• MalfunctionMar 16, 2026Energy Output Problem; Failure to Cut; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE USE OF THREE DEVICES, THE DEVICES DID NOT CUT AND NO SEAL WAS ACHIEVED. THERE WAS NO EVIDENCE OF ENERGY DELIVERY, AND NO END TONES WERE HEARD. THE DEVICES WERE PLUGGED INTO A GENERATOR AT THE TIME OF THE EVENT, AND ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608098 ↗
• MalfunctionMar 10, 2026Difficult to Open or Close

  IT WAS REPORTED THAT FROM THE BEGINNING, WHEN THE DEVICE WAS FIRST USED DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, WHEN THE HANDLE WAS SQUEEZED, THE DEVICE GOT STUCK WHEN APPLIED TO ROUND LIGAMENT. THE ISSUE DELAYED THE SURGEON PERFORMING HEMOSTASIS. THE SURGEON HAD TO STOP UNSTICKING THE HANDLE AND HAD TO BE FORCED OPEN BY PRYING THE RING HANDLES APART IN ORDER TO RELEASE THE TISSUE. THE KNIFE BLADE WAS NOT EXTENDED AND DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. THE DEVICE WAS CLEANED AFTER IT WAS USED. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555605 ↗
• MalfunctionMar 3, 2026Retraction Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER DURING AN OPEN SPLENECTOMY PROCEDURE AT THE BEGINNING AROUND THE THIRD FIRING, RIGHT AS THE SURGERY WAS STARTING. ON THE SPLENIC VESSELS, THE KNIFE BLADE COULD NOT RETRACT AND AFTER MAKING A CUT, THE DOCTOR COULD NOT OPEN THE HANDLE AND WAS HAVING TROUBLE. THE GRAY BUTTON SEEMED TO GET STUCK AND THE DOCTOR HAD TO PUSH IT FROM THE OTHER SIDE TO RELEASE IT. THEY CLEANED THE DEVICE ONCE TO SEE IF THAT WAS THE ISSUE, BUT IT STAYED THE SAME. THE KNIFE BLADE WAS EXTENDED, BUT IT DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. ANOTHER LIGASURE 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 24499065 ↗
• MalfunctionMar 3, 2026Difficult to Open or Close

  IT WAS REPORTED THAT AT THE START OF GYNECOLOGICAL (GYN) LAPAROTOMY PROCEDURE, THE JAW WAS DIFFICULT OR IMPOSSIBLE TO OPEN AND GOT STUCK. THE DEVICE WAS NOT APPLIED TO TISSUE AT THE TIME OF THE ISSUE OCCURRED AND KNIFE BLADE WAS NOT EXTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495247 ↗