LigaSure ImpactRecalls & reported problems across all models

We found 3 models of LigaSure Impact by Covidien LP in the FDA's device registry (GUDID). Together they are named in 382 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2016 and Sep 30, 2026 — classified as 3 deaths, 18 injuries, 361 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (121 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported LigaSure Impact problems

LigaSure Impact models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LigaSure Impact LF4418

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  3 deaths325 reports
• LigaSure Impact LF4318

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  50 reports
• LigaSure Impact LF4200

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  7 reports

Recent LigaSure Impact adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall