LigaSure LF1537Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884524002293), received between Nov 22, 2016 and Apr 28, 2022 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K092879); they may or may not involve this specific model.

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 29 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC LIVER RESECTION BETWEEN JANUARY 2015 AND OCTOBER 2017. THERE WERE 264 PATIENTS IN THE STUDY AND LIGASURE 1537 WAS USED TO TRANSECT VESSELS WITH DIAMETER BETWEEN 3 MM AND 10 MM IN 70 PATIENTS. COMPLICATIONS INCLUDED POSTOPERATIVE HEMORRHAGE WHICH REQUIRED REOPERATION. EXTENDED ICU STAY WAS REPORTED. OTHER COMPLICATIONS THAT WERE NOT RELATED TO THE DEVICE INCLUDED: ASCITES, HYDROTHORAX AND WOUND SUTURE. DOES LIVER CIRRHOSIS HAVE AN IMPACT ON THE RESULTS OF DIFFERENT HEPATIC INFLOW OCCLUSION METHODS IN LAPAROSCOPIC LIVER RESECTION? A PROPENSITY SCORE ANALYSIS: XIANG LAN, 2018, © 2018 INTERNATIONAL HEPATO-PANCREATO-BILIARY ASSOCIATION INC. PUBLISHED BY ELSEVIER LTD. ALL RIGHTS RESERVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14237735 ↗
• MalfunctionMay 6, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, BEFORE USE, THE DEVICE'S JAWS WERE DIFFICULT TO OPEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8583186 ↗
• MalfunctionMay 2, 2019Failure to Deliver Energy; Failure to Deliver Energy

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WORKED FINE AT THE START THEN WHEN THEY TRIED TO USE IT AGAIN THERE WAS NO ENERGY OUTPUT IN THE CUTTER HEAD. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NOTHING DETACHED FROM THE DEVICE AND NOTHING FELL INTO PATIENTS CAVITY. THERE WAS NO PATIENT INJURY. THE MEDTRONIC INITIAL VISUAL INSPECTION FOUND THE METAL FLANGE ON THE DEVICE JAW WAS BROKEN AND MISSING. THE MISSING PIECE WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573542 ↗
• MalfunctionSep 6, 2018Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  ACCORDING TO THE REPORTER, THE CUTTING BUTTON WOULD NOT RETRIEVE BACK ITSELF SO THAT THE CUTTING COULD NOT BE DONE DURING THE PROCEDURE. THE KNIFE BLADE WAS EXTENDED. THE SURGEON CHANGED THE DEVICE, SO THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850766 ↗
• MalfunctionAug 1, 2018Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE DEVICE WAS DIFFICULT OR IMPOSSIBLE TO OPEN. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 7739270 ↗
• MalfunctionAug 1, 2018Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE DEVICE WAS DIFFICULT OR IMPOSSIBLE TO OPEN. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 7739139 ↗
• MalfunctionJul 17, 2018Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE DEVICE WAS DIFFICULT TO OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7694346 ↗
• MalfunctionMay 10, 2018Entrapment of Device; Difficult to Open or Close; Entrapment of Device; Difficult to Open or Close

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, INTRA-OPERATIVELY, THE DEVICE'S BLADE DID NOT ADVANCED, ALSO IT WAS DIFFICULT TO ACTIVATE AND THE JAWS WERE DIFFICULT TO CLOSE. WHEN THE JAWS HAVE BEEN CLAMPED IT WAS NECESSARY TO REMOVE TISSUE WITH THE DEVICE OCCUR ON A BROAD LIGAMENT WITH GREATER THAN 2/3 OF THE JAWS BUT LESS THAN THE LENGTH OF THE JAWS THAT WAS BEING GRASPED. IN TIME JAWS WERE WIPE CLEAN. A REPLACEMENT OF THE DEVICE TO CONTINUE THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 7502887 ↗
• MalfunctionFeb 22, 2018Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT THE DEVICE WAS DIFFICULT TO CLOSE. THE HANDLE COULD NOT BE USED TO OPERATE THE JAWS. THERE WAS NO PATIENT INJURY. EVALUATION OF THE RETURNED DEVICE FOUND THAT A PIECE OF THE JAWS HAD BROKEN OFF AND WAS NOT RETURNED. THE CUSTOMER WAS NOTIFIED AND CONFIRMED THAT NO PIECE OF THE DEVICE FELL WITHIN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7291280 ↗
• MalfunctionDec 11, 2017Mechanical Problem; Retraction Problem; Difficult to Open or Close; Mechanical Problem; Retraction Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE DEVICE CONTROL GRIP HAD PROBLEMS OPENING AND CLOSING. THE KNIFE ADDITIONALLY CANNOT ADVANCE AND RETRACT NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7105128 ↗
• MalfunctionDec 5, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE FIRST DEVICE COULD NOT BE CLOSED AND THE SECOND DEVICE WAS DIFFICULT TO ACTIVATE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085082 ↗
• MalfunctionDec 4, 2017Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER ONE DEVICE BROKE AND THE KNIFE BLADE WOULD NOT RETRACT ON ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7081395 ↗
• MalfunctionNov 30, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE DEVICE WAS DIFFICULT/IMPOSSIBLE TO OPEN. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7073248 ↗
• MalfunctionNov 28, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, TWO DEVICES WERE USED AND THEIR JAWS WERE DIFFICULT AND IMPOSSIBLE TO OPEN. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7065034 ↗
• MalfunctionNov 28, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THERE WAS A MECHANICAL ISSUE WITH THE DEVICE DURING A PROCEDURE. THE DEVICE¿S CUTTING BUTTON DID NOT BOUNCE BACK AFTER ACTIVATING. ANOTHER DEVICE WAS USED BUT THE SAME ISSUE OCCURRED AGAIN. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7065010 ↗
• MalfunctionNov 28, 2017Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, THERE WAS A MECHANICAL ISSUE WITH THE DEVICE DURING A PROCEDURE. THE DEVICE¿S CUTTING BUTTON DID NOT BOUNCE BACK AFTER ACTIVATING. ANOTHER DEVICE WAS USED BUT THE SAME ISSUE OCCURRED AGAIN. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7064100 ↗
• MalfunctionNov 28, 2017Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, THERE WAS A MECHANICAL ISSUE WITH THE DEVICE DURING A PROCEDURE. THE DEVICE¿S CUTTING BUTTON DID NOT BOUNCE BACK AFTER ACTIVATING. ANOTHER DEVICE WAS USED BUT THE SAME ISSUE OCCURRED AGAIN. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7064066 ↗
• MalfunctionOct 11, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, METAL PIECES DETACHED FROM THE JAWS OF THE DEVICE. NO PATIENT INJURY OCCURRED OR MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6943073 ↗
• MalfunctionOct 11, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, METAL PIECES DETACHED FROM THE JAWS OF THE DEVICE. NO PATIENT INJURY OCCURRED OR MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6943023 ↗
• MalfunctionOct 7, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, A METAL PIECE BELOW THE JAW DETACHED. NO PATIENT INJURY RESULTED OR MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6927498 ↗
• MalfunctionSep 12, 2017Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE BROKE AND THE HANDLE COULD NOT BE OPENED. NO PATIENT INJURY OCCURRED OR MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6858305 ↗
• 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. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856997 ↗
• 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. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856992 ↗
• MalfunctionSep 11, 2017Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE JAWS OF THE DEVICE WERE DIFFICULT TO OPEN AND CLOSE. THE ISSUE OCCURRED AFTER SIXTY MINUTES OF USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856653 ↗
• MalfunctionAug 31, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, A JAW COMPONENT DETACHED FROM THE DEVICE WITH INITIAL USE. THE COMPONENT DID NOT FALL WITHIN THE PATIENT CAVITY. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6836323 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092879. One submission often covers many models, so check the product and lot details in each record.

• Z-0954-2011 · Dec 8, 2010 · Terminated
  Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boul