LigaSure LF1937Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,090 adverse event reports that list this exact device (DI 10884521705913), received between Jan 9, 2018 and Sep 30, 2026 — classified as 3 deaths, 87 injuries, 2,000 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (884 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,090 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Open or Close

  Patient problems: Insufficient Information

  MAUDE report 50955155 ↗
• MalfunctionSep 30, 2026Energy Output Problem; Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950576 ↗
• MalfunctionSep 30, 2026Self-Activation or Keying

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949505 ↗
• MalfunctionSep 30, 2026Energy Output Problem

  It was reported that during a procedure, the device had no seal with no evidence of energy delivery observed and end tones heard. Another device was used successfully with the same generator. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946989 ↗
• MalfunctionSep 30, 2026Retraction Problem; Difficult to Open or Close

  It was reported that, during a procedure, the knife blade could not retract, the device was difficult or impossible to open, and the device became stuck on tissue. The jaws were forced open to remove the device from tissue.

  Patient problems: Insufficient Information

  MAUDE report 50943021 ↗
• MalfunctionSep 30, 2026Energy Output Problem

  It was reported that, during use, two devices were connected to a generator. One device had inadequate/partial vessel sealing despite evidence of energy delivery and end tones being heard. The other device activated without the activation button being pressed. Another device was used successfully with the generator. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942987 ↗
• MalfunctionSep 29, 2026Device Alarm System; Energy Output Problem

  It was reported that, during procedure, the device was sealing inadequate with evidence of energy delivery and end tones heard. The seal showed evidence of energy delivery but bleeds after cutting. Another ligasure was used successfully with the same generator. There was a regrasp alarm. No surgical/medical interventions needed and no patient symptoms or complications related to the event. There was no patient harm/injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936423 ↗
• MalfunctionSep 29, 2026Energy Output Problem; Intermittent Energy Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933476 ↗
• MalfunctionSep 29, 2026Device Alarm System; Energy Output Problem; Intermittent Energy Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932986 ↗
• MalfunctionSep 29, 2026Device Alarm System; Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926727 ↗
• MalfunctionSep 28, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926575 ↗
• MalfunctionSep 28, 2026Device Alarm System; Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922209 ↗
• MalfunctionSep 28, 2026Energy Output Problem

  It was reported that during a uterine myoma resection procedure, the device had sealing inadequate or partial vessel sealing despite evidence of energy delivery and end tones heard. Another device was used successfully with the same generator.  There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918518 ↗
• MalfunctionSep 24, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892140 ↗
• MalfunctionSep 24, 2026Device Alarm System; Energy Output Problem

  It was reported that during a colon per diverticulitis procedure with a use of the device to seal peritoneal tissue, the handpiece had inadequate seal despite evidence of energy delivery and audible end tones. It also alarmed with an error indicating interruption of use before completion of the vessel seal. No successful seals were achieved before the issue occurred. The device was replaced after the first activations. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885157 ↗
• InjurySep 22, 2026Device Alarm System; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  It was reported that during a laparoscopic procedure, the LigaSure Maryland 37 cm device initially functioned as intended but failed to complete the seal cycle after approximately 10 to 15 successful seals of 20 millimeter omentum and vessels. The device displayed the message, ¿End point not reached, seal cycle interrupted¿. The device jaws were cleaned, and the device was disconnected from and reconnected to the generator; however, the device continued to fail to complete the seal cycle. The procedure was subsequently converted to open splenectomy, pancreatectomy, bowel surgery and stoma creation. A LigaSure Impact device then completed approximately one to two seal cycles of 20 millimeter vascular and connective tissue around the spleen before a similar issue occurred, with the error message ¿End point not reached, seal cycle interrupted¿ displayed.  A second LigaSure Impact device was opened as a replacement and functioned as intended, allowing the procedure to proceed.

  Patient problems: Insufficient Information

  MAUDE report 50859343 ↗
• MalfunctionSep 22, 2026Mechanical Problem; Failure to Cut; Difficult to Open or Close; Intermittent Energy Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849409 ↗
• MalfunctionSep 21, 2026Retraction Problem; Difficult to Open or Close; Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849282 ↗
• MalfunctionSep 21, 2026Difficult to Open or Close; Intermittent Energy Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849130 ↗
• MalfunctionSep 17, 2026Energy Output Problem

  It was reported that during a right laparoscopic hemicolectomy, inadequate or partial vessel sealing occurred with the device despite evidence of energy delivery and audible end tones. There was no re-grasp alarm and there was no good seal completed It was used on a 6.5 to 10mm mesentery tissue. It was cleaned few times for troubleshooting purposes only, tips were checked and free from eschar. The device was connected to an FT10 unit. Another device was used successfully with the same unit. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797913 ↗
• MalfunctionSep 11, 2026Energy Output Problem

  It was reported that during a sleeve gastrectomy procedure with a use of the device, inadequate or partial vessel sealing occurred despite evidence of energy delivery and end tones being heard. There was no re-grasp alert. Minimal bleeding that did not require transfusion was observed after cutting following the seal. There were no good seals completed prior to the issue. It was used on regular short gastric vessels. The device was connected to a generator, 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 50728553 ↗
• MalfunctionSep 11, 2026Retraction Problem

  It was reported that, during a total laparoscopic hysterectomy, the handpiece knife blade cannot be pulled back. The knife blade was not exposed nor protruded beyond the edge of the jaws. A new device was taken out and the condition was improved. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728027 ↗
• MalfunctionSep 11, 2026Energy Output Problem

  It was reported that during a procedure with a use of the device, inadequate/partial tissue sealing occurred despite evidence of energy delivery and audible end tones. The device was connected to a generator, and another device was used successfully with the same generator.

  Patient problems: Insufficient Information

  MAUDE report 50728025 ↗
• MalfunctionSep 11, 2026Mechanical Problem; Difficult to Open or Close; Intermittent Energy Output

  According to the reporter, during a VATS esophagectomy procedure, at the time of dissection of the tissue surrounding the stomach, about 6 hours after starting use, it seemed that tissue had entered inside the jaw, it was difficult/unable to pull the cutting trigger, and the jaw could no longer open. Another ligasure device was reported to have been used successfully with the same generator. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727537 ↗
• MalfunctionSep 11, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that during a procedure, after approximately 10¿12 successful seals, no seal with no evidence of energy delivery and end tones heard occurred during activation. Another device was used successfully with the same generator. Bleeding occurred.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50727319 ↗