N/A LF4418Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613327417845), received between Nov 14, 2019 and Apr 8, 2026 — classified as 10 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (8 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Output Problem

  IT WAS REPORTED THE DEVICE WAS "NOT WORKING." IT DIDN'T FIRE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24822495 ↗
• MalfunctionApr 6, 2026Use of Device Problem; Device Dislodged or Dislocated; Material Protrusion/Extrusion

  IT WAS REPORTED THE LIGASURE BROKE IN THE OR. IT WAS ONLY USED ONCE BEFORE (BLADE WARPED AND JAMMED, WON'T EVEN RETRACT AT THIS POINT). REPLACED WITH DUPLICATE REPROCESSED HANDPIECE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 5 MINUTES OR LESS, BACKUP UNITS KEPT ON TOWER SO RIGHT AT HAND. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795513 ↗
• MalfunctionFeb 12, 2026Output Problem

  IT WAS REPORTED THAT THE LIGASURE WOULD NOT TURN ON EVEN WHEN PLUGGED IN, NO NOISE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 10 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328488 ↗
• MalfunctionJan 9, 2026Output Problem

  IT WAS REPORTED THAT THE LIGASURE WAS NOT WORKING. IT WAS PLUGGED IN BUT WAS NO OPERATING WHEN ATTEMPTED TO USE ON THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES TO GET AND OPEN ANOTHER ONE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020300 ↗
• MalfunctionJan 9, 2026Output Problem

  IT WAS REPORTED THAT THE LIGASURE REPEATEDLY GAVE THE "SEAL CYCLE INCOMPLETE" ERROR. THE JAWS WERE CLEANED BUT THE ERROR WAS STILL RECEIVED EVERY OTHER TIME CUTTING WAS ATTEMPTED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019803 ↗
• InjuryNov 3, 2025Use of Device Problem; Device Dislodged or Dislocated; Material Protrusion/Extrusion; Use of Device Problem; Device Dislodged or Dislocated; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE DEVICE HAD A DEFECTIVE BLADE AND THERE WAS TEARING OF PATIENT'S TISSUE. IT WAS FURTHER REPORTED THAT STITCHES WERE USED TO REPAIR THE TISSUE AND THERE WAS UNEXPECTED PATIENT BLEEDING THAT WAS CONTROLLED SUCCESSFULLY. AS REPORTED, THE PATIENT REQUIRED A TRANSFUSION BUT NOT BECAUSE OF THIS INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND EXTENDED PROCEDURE TIME REPORTED WAS A COUPLE OF MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23458183 ↗
• MalfunctionAug 4, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE LIGASURE WAS DIFFICULT TO UNLOCK AND HAD TO BE PULLED TO GET IT OPENED. AS REPORTED, THE SURGERY WAS ABLE TO BE COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709411 ↗
• MalfunctionJul 2, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE TRIGGER WOULD NOT RELEASE ON THE LF4418. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383926 ↗
• MalfunctionJun 18, 2025Misfire; Misfire

  IT WAS REPORTED THAT THE LIGASURE MISFIRED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287877 ↗
• MalfunctionJun 17, 2025Contamination; Material Fragmentation; Contamination; Material Fragmentation

  IT WAS REPORTED THAT THE LIGASURE DEVICE WAS OPENED AND INSIDE WERE BLACK DUST SPECS THAT COULD NOT BE IDENTIFIED. AS REPORTED, THE DEVICE WAS OPENED BEFORE THE CASE AND THE BLACK PARTICLES WERE PRESENT INSIDE BEFORE THE DEVICE WAS OPENED. BECAUSE THE PACKAGING WAS OPENED BEFORE THE SALES REPRESENTATIVE WAS THERE, IT WAS NO POSSIBLE TO DETERMINE IF THIS WAS SOMETHING THAT HAD OCCURRED DURING SHIPPING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22240487 ↗
• MalfunctionJul 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE BLADE ON DEVICE POPPED OUT. IT MALFUNCTIONED WITH AN EXPOSED BLADE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIVE TO TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19670253 ↗
• MalfunctionJul 1, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE LIGASURE HAD A BENT PRONG. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645861 ↗
• InjuryFeb 8, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THE DEVICE FAILED DURING TRAUMA AND REQUIRED SUTURING TO SEAL. THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672665 ↗
• MalfunctionJan 9, 2024Energy Output Problem; Activation Problem; Energy Output Problem; Activation Problem

  IT WAS REPORTED THE DEVICE WOULD EITHER NOT HEAT OR NOT RETAIN HEAT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480454 ↗
• MalfunctionJan 9, 2024Energy Output Problem; Activation Problem; Energy Output Problem; Activation Problem

  IT WAS REPORTED THE DEVICE WOULD EITHER NOT HEAT OR NOT RETAIN HEAT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED, AND NO INFORMATION WAS PROVIDED REGARDING EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480453 ↗
• MalfunctionJan 9, 2024Energy Output Problem; Activation Problem; Energy Output Problem; Activation Problem

  IT WAS REPORTED THE DEVICE WOULD EITHER NOT HEAT OR NOT RETAIN HEAT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480450 ↗
• MalfunctionJan 9, 2024Energy Output Problem; Activation Problem; Energy Output Problem; Activation Problem

  IT WAS REPORTED THE DEVICE WOULD EITHER NOT HEAT OR NOT RETAIN HEAT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED, AND NO INFORMATION WAS PROVIDED REGARDING EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480449 ↗
• MalfunctionJan 9, 2024Energy Output Problem; Activation Problem; Energy Output Problem; Activation Problem

  IT WAS REPORTED THE DEVICE WOULD EITHER NOT HEAT OR NOT RETAIN HEAT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480446 ↗
• MalfunctionJan 9, 2024Energy Output Problem; Activation Problem; Energy Output Problem; Activation Problem

  IT WAS REPORTED THE DEVICE WOULD EITHER NOT HEAT OR NOT RETAIN HEAT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480444 ↗
• InjuryMar 20, 2023Mechanics Altered; Mechanics Altered

  IT IS UNKNOWN IF THE DEVICE FAILED TO SEAL, REPORTED AN ERROR MESSAGE ON THE GENERATOR, OR FAILED TO CUT. THE SURGEON STATED THE PATIENT HAD MORE BLEEDING AND SUTURES WERE REQUIRED. EXTENDED PROCEDURE TIME WAS TO REPLACE DEVICE AND SUTURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16572157 ↗
• InjuryMar 20, 2023Mechanics Altered; Mechanics Altered

  IT IS UNKNOWN IF THE DEVICE FAILED TO SEAL, REPORTED AN ERROR MESSAGE ON THE GENERATOR, OR FAILED TO CUT. THE SURGEON STATED THE PATIENT HAD MORE BLEEDING AND SUTURES WERE REQUIRED. EXTENDED PROCEDURE TIME WAS TO REPLACE DEVICE AND SUTURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16572150 ↗
• InjuryMar 20, 2023Mechanics Altered; Mechanics Altered

  IT IS UNKNOWN IF THE DEVICE FAILED TO SEAL, REPORTED AN ERROR MESSAGE ON THE GENERATOR, OR FAILED TO CUT. THE SURGEON STATED THE PATIENT HAD MORE BLEEDING AND SUTURES WERE REQUIRED. EXTENDED PROCEDURE TIME WAS TO REPLACE DEVICE AND SUTURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16572148 ↗
• InjuryMar 20, 2023Mechanics Altered; Mechanics Altered

  IT IS UNKNOWN IF THE DEVICE FAILED TO SEAL, REPORTED AN ERROR MESSAGE ON THE GENERATOR, OR FAILED TO CUT. THE SURGEON STATED THE PATIENT HAD MORE BLEEDING AND SUTURES WERE REQUIRED. EXTENDED PROCEDURE TIME WAS TO REPLACE DEVICE AND SUTURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16572147 ↗
• InjuryMar 20, 2023Mechanics Altered; Mechanics Altered

  IT IS UNKNOWN IF THE DEVICE FAILED TO SEAL, REPORTED AN ERROR MESSAGE ON THE GENERATOR, OR FAILED TO CUT. THE SURGEON STATED THE PATIENT HAD MORE BLEEDING AND SUTURES WERE REQUIRED. EXTENDED PROCEDURE TIME WAS TO REPLACE DEVICE AND SUTURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16572145 ↗
• InjuryMar 20, 2023Mechanics Altered; Mechanics Altered

  IT IS UNKNOWN IF THE DEVICE FAILED TO SEAL, REPORTED AN ERROR MESSAGE ON THE GENERATOR, OR FAILED TO CUT. THE SURGEON STATED THE PATIENT HAD MORE BLEEDING AND SUTURES WERE REQUIRED. EXTENDED PROCEDURE TIME WAS TO REPLACE DEVICE AND SUTURE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16572140 ↗