LigaSure LF1644Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521210868), received between Jun 21, 2016 and Oct 31, 2020 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE TISSUE WAS STICKING TO THE JAWS OF THE DEVICE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10767428 ↗
• MalfunctionSep 25, 2018Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD A CLOTTING ISSUE. THE DEVICE WAS CHANGED TO PREVENT HARM TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7907917 ↗
• MalfunctionAug 23, 2017Detachment Of Device Component; Peeled/Delaminated; Detachment Of Device Component; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, A WIRE-LIKE PIECE OF THE BLACK SLEEVE BECAME LOOSE AND FELL INTO THE PATIENT'S CAVITY. THE PIECE WAS RETRIEVED WITH LAPAROSCOPIC GRASPERS AND NO PATIENT INJURY RESULTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6815525 ↗
• InjuryMay 8, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  THE CUSTOMER REPORTED THAT AFTER A PROCEDURE WHERE THE DEVICE WAS USED FOR SEALING GASTRIC VESSELS, BLEEDING OCCURRED FROM ONE OF THE SEAL SITES. THE PROCEDURE WAS ON (B)(6) 2017 AND THE ISSUE REQUIRED A REOPERATION ON (B)(6) 2017. OVER 500CC¿S OF BLOOD LOSS IS ESTIMATED, BUT NO TRANSFUSION WAS PERFORMED. THE PATIENT IS CURRENTLY WITHIN THE HOSPITAL.

  Patient problems: Blood Loss

  MAUDE report 6553123 ↗
• MalfunctionSep 9, 2016Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT SEALING CORRECTLY EVEN THOUGH END TONES WERE HEARD. BLOOD LOSS FROM THE GASTRIC BRANCHES OF THE EPIPLOIC VESSELS WAS 30-70 ML AS A RESULT. THERE WAS NO INJURY TO THE PATIENT.

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

  MAUDE report 5940697 ↗
• MalfunctionJun 21, 2016Energy Output Problem; Energy Output Problem

  THE CUSTOMER REPORTED THAT WHILE PERFORMING A SLEEVE GASTRECTOMY BLEEDING WAS NOTED. END TONES, INDICATING A COMPLETE SEAL CYCLE, WERE PROVIDED BY THE GENERATOR IN USE. THE BLOOD LOSS WAS DESCRIBED AS MINIMAL AND THERE WAS NO PATIENT INJURY. A NEW INSTRUMENT OF THE SAME TYPE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5738108 ↗