LigaSure Impact LF4200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521103351), received between Jul 18, 2017 and Dec 8, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2022Energy Output Problem; Energy Output Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED THE RISK FACTORS OF DELAYED POST-HEMORRHOIDECTOMY BLEEDING FOLLOWING DEVICE HEMORRHOIDECTOMY BETWEEN MARCH 2009 TO DECEMBER 2017. DEVICE WAS APPLIED ON THE PEDICLES OF HEMORRHOIDS TO LIGATE THE VESSELS. THERE WERE 437 PATIENTS IN THE STUDY AND 22 PATIENTS DEVELOPED DELAYED BLEEDING. 18 OUT OF 22 PATIENTS REQUIRED HOSPITALIZATION AND 12 PATIENTS REQUIRED SURGICAL HEMOSTATIC INTERVENTION. TWO PATIENTS DEVELOPED RECURRENT BLEEDING AND WERE RE-ADMITTED. BOTH PATIENTS UNDERWENT SURGICAL HEMOSTASIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15942827 ↗
• MalfunctionJan 28, 2021Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE LOCKED ON TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11243685 ↗
• MalfunctionJul 25, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A ROUTINE INSPECTION THE DEVICE WAS DIFFICULT/UNABLE TO OPEN. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8829206 ↗
• MalfunctionJul 31, 2018Mechanical Problem; Failure to Advance; Mechanical Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD A CUTTING/KNIFE ISSUE, THE KNIFE BLADE DID NOT ADVANCE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736122 ↗
• MalfunctionSep 11, 2017Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856976 ↗
• MalfunctionSep 11, 2017Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD AN ISSUE WITH SELF-ACTIVATION. IT WOULD ACTIVATE WITHOUT PRESSING THE BUTTON.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6856889 ↗
• MalfunctionJul 18, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE ACTIVATED NORMALLY BUT APPROXIMATELY 50CC'S OF BLEEDING RESULTED. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO CONTINUE THE PROCEDURE. NO SERIOUS INJURY OCCURRED OR MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6721749 ↗