LigaSure XP LXMJ37SRecalls & reported problems

Summary

The FDA's MAUDE database contains 196 adverse event reports that list this exact device (DI 10884521830943), received between Sep 13, 2023 and Sep 30, 2026 — classified as 6 injuries, 190 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (110 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 25 most recent of 196 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem; Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950796 ↗
• MalfunctionSep 30, 2026Difficult to Open or Close

  It was reported that during a surgical case, the Device XP Inline Sealer/Divider 37 cm jaws were difficult to open and did not open properly. The affected device was switched out and replaced with a new XP device. The scrub cleaned the device on any opportunity when it was not being used in the procedure with damp gauze. The knife blade did not extended and protrude beyond the edge of the jaws. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946813 ↗
• MalfunctionSep 30, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946395 ↗
• MalfunctionSep 28, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923586 ↗
• MalfunctionSep 22, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862796 ↗
• MalfunctionSep 21, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849367 ↗
• MalfunctionSep 17, 2026Failure to Cut

  The Ligasure stopped cutting in the middle of the case.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802037 ↗
• MalfunctionSep 11, 2026Mechanical Problem; Retraction Problem

  It was reported that, during a procedure, the device trigger was jammed and did not move smoothly while connected to a generator. The knife blade could not advance or retract. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728339 ↗
• MalfunctionSep 11, 2026Difficult to Open or Close

  According to the reporter, during procedure, jaw of the device froze and would not open during a critical part of the case (arterial bleed) artery was manually clamed while a new product was opened.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50728209 ↗
• MalfunctionSep 8, 2026Difficult to Open or Close; Intermittent Energy Output

  It was reported that halfway through a total laparoscopic hysterectomy with the use of the device, the device jaws would not open after tissue was clamped for sealing and ligation. It was used on a uterine artery and there was minimal eschar build up in the jaws. The knife blade was not extended nor protruded beyond the edge of the jaws. The device was removed from the operating field, and another manufacturer¿s device was obtained and used. The procedure was extended by 5 minutes. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668956 ↗
• MalfunctionAug 28, 2026Retraction Problem; Difficult to Open or Close; Intermittent Energy Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50494062 ↗
• MalfunctionAug 25, 2026Device Alarm System; Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436421 ↗
• InjuryAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed. There was no re-grasp alert. Blood transfusion was required. The device was used during a low anterior resection procedure on vessels, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423798 ↗
• InjuryAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed. There was no re-grasp alert. Blood transfusion was required. The device was used during a low anterior resection procedure on vessels, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423792 ↗
• InjuryAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed. There was no re-grasp alert. Blood transfusion was required. The device was used during a low anterior resection procedure on vessels, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423789 ↗
• MalfunctionAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed around 5-10 ml after cutting. There was no re-grasp alert. Blood transfusion was not required. The device was used during a low anterior resection procedure on upper GI tissue/vessels with tissue thickness reported around 4-5mm, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423700 ↗
• MalfunctionAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed around 5-10 ml after cutting. There was no re-grasp alert. Blood transfusion was not required. The device was used during a low anterior resection procedure on upper GI tissue/vessels with tissue thickness reported around 4-5mm, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423628 ↗
• MalfunctionAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed around 5-10 ml after cutting. There was no re-grasp alert. Blood transfusion was not required. The device was used during a low anterior resection procedure on upper GI tissue/vessels with tissue thickness reported around 4-5mm, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423552 ↗
• MalfunctionAug 25, 2026Energy Output Problem; Intermittent Energy Output

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423457 ↗
• MalfunctionAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed around 5-10 ml after cutting. There was no re-grasp alert. Blood transfusion was not required. The device was used during a low anterior resection procedure on vessels with tissue thickness reported around 4-5mm, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423439 ↗
• MalfunctionAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed around 5-10 ml after cutting. There was no re-grasp alert. Blood transfusion was not required. The device was used during a low anterior resection procedure on vessels with tissue thickness reported around 4-5mm, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423430 ↗
• MalfunctionAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed around 5-10 ml after cutting. There was no re-grasp alert. Blood transfusion was not required. The device was used during a low anterior resection procedure on vessels with tissue thickness reported around 4-5mm, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423429 ↗
• MalfunctionAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed around 5-10 ml after cutting. There was no re-grasp alert. Blood transfusion was not required. The device was used during a low anterior resection procedure on vessels with tissue thickness reported around 4-5mm, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423417 ↗
• MalfunctionAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed around 5-10 ml after cutting. There was no re-grasp alert. Blood transfusion was not required. The device was used during a low anterior resection procedure on vessels with tissue thickness reported around 4-5mm, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423413 ↗
• MalfunctionAug 25, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that sealing was described as inadequate or partial despite evidence of energy delivery and end tones being heard, and the seal was reported to bleed around 5-10 ml after cutting. There was no re-grasp alert. Blood transfusion was not required. The device was used during a low anterior resection procedure on vessels with tissue thickness reported around 4-5mm, after a few good seals before it started giving problem. Jaw cleaning was done after every 3-4 time of usage. Another device was reported to have been used successfully with the same generator.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50423404 ↗