LigaSure Atlas LS1037Recalls & reported problems

Summary

The FDA's MAUDE database contains 254 adverse event reports that list this exact device (DI 10884524001630), received between Mar 8, 2016 and Aug 3, 2026 — classified as 1 death, 29 injuries, 224 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (87 reports).

2 other recalls cover devices cleared under the same FDA submission (K010013); 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. 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 254 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123092 ↗
• MalfunctionMar 31, 2026Break; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE WITH A USE OF THE DEVICE, A JAW ISSUE WAS IDENTIFIED, SPECIFICALLY AN EXPOSED WIRE ON THE DEVICE JAWS. THE DEVICE WAS PLUGGED INTO A GENERATOR AND ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. PHOTO WAS SUBMITTED SHOWING THE INSULATION ON THE WIRE WAS PEELED OFF. NOTHING FELL ON PATIENT'S CAVITY AND NO ADDITIONAL INTERVENTION WAS NEEDED DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740496 ↗
• MalfunctionMar 16, 2026Difficult to Open or Close; Protective Measures Problem

  IT WAS REPORTED THAT PRIOR TO USE, A BRAND-NEW DEVICE WAS OUT OF MANUFACTURER PACKAGING, BUT THE HANDLE WAS STUCK AND WOULD NOT OPEN PROPERLY. THE DEVICE COULD EXTEND BUT IT DID NOT EXTEND WHEN THE JAWS WERE OPEN. THE KNIFE BLADE PROTRUDED BEYOND THE EDGE OF THE JAWS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607505 ↗
• MalfunctionOct 23, 2025Break; Mechanical Problem; Energy Output Problem; Peeled/Delaminated; Break; Mechanical Problem; Energy Output Problem; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING PROCEDURE, THE HAND SWITCH WAS NOT REACTING TO THE ACTIVATION AND THERE WAS MECHANICAL FAILURE OF THE KNIFE (JAW) WHEN PUSHING THE TRIGGER. PHOTO OBSERVATION SHOWS THAT THE WIRE IS CUT AND STICKING OUT. THERE WAS NO COAGULATION. THE SECOND LIGASURE AFTER 2 COAGULATIONS THE JAWS CLAMPED THE TISSUE AND WOULD NOT RELEASE, AFTER A FEW CLICKS THE JAWS OPENED AND THE INSTRUMENT STOPPED WORKING. IT FAILED OPERATION AND SOMETHING INSIDE BROKE. AS A RESULT, THE PATIENT STARTED BLEEDING (200 ML) AND THEY HAD TO STOP IT. TO STOP THE BLEEDING A CLIP WAS PLACED AND THE VESSEL WAS CLAMPED. SINCE THE PATIENT ALREADY HAD ANEMIA, TWO DOSES (500 ML) WAS ADMINISTERED DURING THE OPERATION AS PLANNED. ANOTHER LIGASURE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23370317 ↗
• MalfunctionOct 23, 2025Energy Output Problem; Difficult to Open or Close; Intermittent Energy Output; Energy Output Problem; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING PROCEDURE, THE HAND SWITCH WAS NOT REACTING TO THE ACTIVATION AND THERE WAS MECHANICAL FAILURE OF THE KNIFE (JAW) WHEN PUSHING THE TRIGGER. PHOTO OBSERVATION SHOWS THAT THE WIRE IS CUT AND STICKING OUT. THERE WAS NO COAGULATION. THE SECOND LIGASURE AFTER 2 COAGULATIONS THE JAWS CLAMPED THE TISSUE AND WOULD NOT RELEASE, AFTER A FEW CLICKS THE JAWS OPENED AND THE INSTRUMENT STOPPED WORKING. IT FAILED OPERATION AND SOMETHING INSIDE BROKE. AS A RESULT, THE PATIENT STARTED BLEEDING (200 ML) AND THEY HAD TO STOP IT. TO STOP THE BLEEDING A CLIP WAS PLACED AND THE VESSEL WAS CLAMPED. SINCE THE PATIENT ALREADY HAD ANEMIA, TWO DOSES (500 ML) WAS ADMINISTERED DURING THE OPERATION AS PLANNED. ANOTHER LIGASURE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23368167 ↗
• MalfunctionSep 3, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE INSULATION OF THE HANDPIECE WAS FLAKING. IT WAS NOTICED OUTSIDE THE PATIENTS ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949812 ↗
• MalfunctionAug 26, 2025Peeled/Delaminated; Difficult to Remove; Detachment of Device or Device Component; Peeled/Delaminated; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE WAS USED AND PULLED OUT THROUGH THE TROCAR. THE DEVICE HAS SEVERAL CABLES AND THEY PULLEY RIPPED. ANOTHER DEVICE WAS USED BUT HAD THE SAME PROBLEM. ONE HANDPIECE WAS RETURNED BACK TO STOCK. THERE WAS A SMALL PIECES OF THE BROKEN CABLE FELL INTO THE PATIENT¿S CAVITY. SOME PIECES WERE TAKEN OUT, BUT SOME PIECES WERE TOO SMALL AND COULDN¿T BE RETRIEVED FULLY. THE PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES AND NO ANY MEDICAL INTERVENTION/SURGICAL INTERVENTION TO RETRIEVE THE BROKEN PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22898730 ↗
• MalfunctionAug 26, 2025Peeled/Delaminated; Difficult to Remove; Detachment of Device or Device Component; No Apparent Adverse Event; Peeled/Delaminated; Difficult to Remove; Detachment of Device or Device Component; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE WAS USED AND PULLED OUT THROUGH THE TROCAR. THE DEVICE HAS SEVERAL CABLES AND THEY PULLEY RIPPED. ANOTHER DEVICE WAS USED BUT HAD THE SAME PROBLEM. ONE HANDPIECE WAS RETURNED BACK TO STOCK. THERE WAS A SMALL PIECES OF THE BROKEN CABLE FELL INTO THE PATIENT¿S CAVITY. SOME PIECES WERE TAKEN OUT, BUT SOME PIECES WERE TOO SMALL AND COULDN¿T BE RETRIEVED FULLY. THE PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES AND NO ANY MEDICAL INTERVENTION/SURGICAL INTERVENTION TO RETRIEVE THE BROKEN PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22898630 ↗
• MalfunctionAug 17, 2025Break; Peeled/Delaminated; Detachment of Device or Device Component; Break; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE; THE DEVICE¿S INSULATION WAS DETACHED OR FELL OFF BUT NOTHING FELL ON PATIENT'S CAVITY. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY. PHOTOGRAPH WAS RECEIVED AND SHOWED THAT THE WIRE LOCATED AT THE TOP OF THE JAW WAS CUT OFF, EXPOSED AND FRAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824310 ↗
• MalfunctionJul 3, 2025Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  ACCORDING TO THE REPORTER AT THE BEGINNING OF THE PROCEDURE, THE HANDPIECE HAD NO SEAL. THERE WAS NO EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. THERE WAS NO GOOD SEAL COMPLETED AND IT WAS USED ON LUNG TISSUE LESS THAN 7 MM. A NEW HANDPIECE WAS USED AND IT WORKED FINE. THERE WAS BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22393847 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE LS1037 LIGASURE ATLAS HANDSWITCH 37CM, THE DEVICE PULL HANDLE WAS DIFFICULT OR IMPOSSIBLE TO PULL, AND THE HANDLE GOT BROKEN. A PIECE OF THE DEVICE FULLY DETACHED AND FELL INTO THE PATIENT'S CAVITY, BUT IT WAS RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 21753144 ↗
• MalfunctionMar 19, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE'S BRANCHES DID NOT OPEN AND CLOSE PROPERLY. THE KNIFE BLADE WAS NOT EXTENDED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644957 ↗
• MalfunctionMar 6, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER DURING WHIPPLE PROCEDURE, IN THE INITIAL HOUR OF THE CASE THE DEVICE WAS LOCKED ON TISSUE AND WOULDN'T RELEASE SO THE SURROUNDING TISSUE WAS RESECTED AROUND THE JAWS TO RELEASE IT. THIS OCCURRED IN USE ON THE OMENTUM AS THEY WERE DISSECTING THIS TISSUE TO GET TO THE AREA THEY WERE INTENDING TO WORK IN. THE DOCTOR SAID WHEN IT LOCKED ON THE TISSUE, USED CLAMPS ON BOTH SIDES OF THE JAWS AND THEN TIED OFF A SMALL VESSEL ON BOTH SIDES AND THEN DIVIDED THE TISSUE AROUND THE JAWS. THE SURGERY WAS EXTENDED FOR ABOUT 5-10 MINUTES. ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THIS GENERATOR. IT WAS NOT NOTICED IF THE KNIFE BLADE WAS EXTENDED. THE JAWS OF THE DEVICE DO OPEN NOW, BUT IT SEEMS AT A DELAYED RESPONSE TO THE HANDLE MECHANISM.

  Patient problems: Tissue Breakdown

  MAUDE report 21534372 ↗
• MalfunctionFeb 12, 2025Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDPIECE HAD INADEQUATE/PARTIAL SEALING. THERE WAS EVIDENCE OF ENERGY DELIVERY AND END TONES WERE HEARD. A NEW HANDPIECE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366751 ↗
• MalfunctionJan 6, 2025Energy Output Problem; Difficult to Open or Close; Intermittent Energy Output; Separation Problem; Energy Output Problem; Difficult to Open or Close; Intermittent Energy Output; Separation Problem

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF A HYSTERECTOMY PROCEDURE, THE HANDPIECE DID NOT COAGULATE PROPERLY, THE HANDLE OF THE CLAMP COULD NOT BE OPENED AND IT TORE OFF THE COAGULATED TISSUE CAUSING BLEEDING, SO IT HAD TO BE CHANGED. THERE WAS NO RE-GRASP ALERT AND ACTIVATION TONE WAS HEARD WHEN THE CONNECTION WAS MADE. THE CLAMP WAS WIPED WITH A WET COMPRESS (WITH SALINE SOLUTION) AFTER THE CUT SEAL WAS PERFORMED. HANDPIECE WAS ABLE TO COMPLETE TWO TO THREE GOOD SEALS BEFORE THE ISSUE OCCURRED. THE VIDEO WAS SUBMITTED SHOWING JAWS CANNOT BE OPENED AND UTERINE TISSUE WAS STICKING TO THE JAWS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 21079090 ↗
• MalfunctionAug 7, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING OPEN LEFT COLON RESECTION, DEVICE SEALING WAS INADEQUATE WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD. IT WAS DURING THE MOBILIZATION OF COLON. THE SEAL SHOWED EVIDENCE OF ENERGY DELIVERY, BUT BLEEDS AFTER CUTTING. ANOTHER DEVICE WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19928642 ↗
• MalfunctionJul 18, 2024Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD NO SEAL ON MESENTERY VESSEL. THERE WAS NO EVIDENCE OF ENERGY DELIVERY AND END TONES WAS HEARD. THERE WAS NO BLEEDING. ANOTHER DEVICE WAS USED SUCCESSFULLY USING THE SAME GENERATOR. NO MEDICAL OR SURGICAL INTERVENTIONS NEEDED AND EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19774666 ↗
• MalfunctionJul 18, 2024Break; Peeled/Delaminated; Detachment of Device or Device Component; Break; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWO UNITS OF LS1037 GOT THE SAME ISSUE, INSULATION GOT REMOVED AFTER INSERTING THE INSTRUMENT WHILE INSERTING INTO THE GENERATOR'S PORT. NONE OF THE PIECE FELL INTO THE PATIENT'S CAVITY. ON THE PHOTO PROVIDED IT CAN ALSO BE SEEN THAT THE WIRE ON THE JAW WAS EXPOSED AND BROKEN. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE LIGASURE DEVICES HAVE INSULATION DAMAGE. THERE WAS AN EVIDENCE OF USE AND THE PORTION OF THE INSULATION OF THE WIRE ON THE LIGASURE DEVICES WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771526 ↗
• MalfunctionJul 18, 2024Break; Peeled/Delaminated; Detachment of Device or Device Component; Break; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, TWO UNITS OF LS1037 GOT THE SAME ISSUE; INSULATION GOT REMOVED AFTER INSERTING THE INSTRUMENT IN THE GENERATOR'S PORT. ON THE PHOTO PROVIDED, IT CAN ALSO BE SEEN THAT THE WIRE ON THE JAW WAS EXPOSED AND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE LIGASURE DEVICES HAVE INSULATION DAMAGE. THERE WAS AN EVIDENCE OF USE AND THE PORTION OF THE INSULATION OF THE WIRE ON THE LIGASURE DEVICES WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771517 ↗
• MalfunctionJun 21, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DEVICE WAS GRASPING A PIECE OF TISSUE AND THE JAWS WOULD NOT RELEASE. THE SURGEON DISSECTED THE TISSUE WITH ROBOTIC INSTRUMENTATION TO SAFELY REMOVE THE DEVICE FROM THE PATIENT. PRODUCT WAS REMOVED FROM THE FIELD, PLACED IN A BAG FOR MATERIALS MANAGEMENT, AND A REPLACEMENT DEVICE (BLUNT TIP LIGASURE) WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19587504 ↗
• MalfunctionJun 14, 2024Difficult to Open or Close; Separation Problem; Difficult to Open or Close; Separation Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE JAWS DID NOT OPEN CORRECTLY BEFORE PICKING UP THE TISSUE AND BECAME STUCK WITH THE TISSUE CAUGHT. AT A MOMENT WHEN THE JAWS OF THE PRODUCT COULD BE OPENED, A SEAL WAS MADE ON ONE OF THE VESSELS CLOSE TO THE UTERINE ARTERY AND THEN AN ATTEMPT WAS MADE TO OPEN THE CLAMP AND IT WAS NOT POSSIBLE. THE DOCTOR INTRODUCED ANOTHER DEVICE LIGASURE MARYLAND LF1923 TO TRY TO FREE THE JAWS FROM THE LOCKED DEVICE AND IT WAS UNSUCCESSFUL. AT THAT TIME, THE DOCTOR HAD TO USE GREATER FORCE ON THE HANDLE TO RELEASE THE PRODUCT UNTIL SOME OF THE TISSUE WAS TORN BUT IT COULD BE CONTROLLED BY USING AND SEALING WITH THE LIGASURE MARYLAND. THIS OCCURRED IN THE VESSELS CLOSE TO THE UTERINE ARTERIES. THE DEVICE WAS CONSTANTLY CLEANED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19538278 ↗
• MalfunctionApr 5, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDPIECE WOULD NOT RELEASE FROM THE PATIENTS TISSUE. SURGEON WAS ABLE TO GET IT OFF AND THEY CHANGED TO ANOTHER HANDPIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054654 ↗
• MalfunctionMar 12, 2024Entrapment of Device; Retraction Problem; Difficult to Open or Close; Protective Measures Problem; Entrapment of Device; Retraction Problem; Difficult to Open or Close; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING GYNECOLOGICAL PROCEDURE, AS SOON AS THEY STARTED TO USE THE LS1037 TO RESECT THE LIGAMENTS THE JAWS REMAINED CLAMPED ON TISSUE. THE JAWS GOT STUCK ON THE TISSUE AND WOULD NOT OPEN HENCE THEY HAD TO USE A FORCEPS TO OPEN. THE KNIFE BLADE WAS EXTENDED AND RETRACTED. THE PROCEDURE WAS COMPLETED WITH NEW SYSTEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891647 ↗
• MalfunctionFeb 23, 2024Entrapment of Device; Retraction Problem; Difficult to Open or Close; Protective Measures Problem; Entrapment of Device; Retraction Problem; Difficult to Open or Close; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING GYNECOLOGICAL PROCEDURE, AS SOON AS THEY STARTED TO USE THE DEVICE TO RESECT THE LIGAMENTS THE JAWS REMAINED CLAMPED ON TISSUE. THE JAWS GOT STUCK ON THE TISSUE AND WOULD NOT OPEN HENCE THEY HAD TO USE A FORCEPS TO OPEN. THE KNIFE BLADE WAS EXTENDED AND RETRACTED. THE PROCEDURE WAS COMPLETED WITH NEW SYSTEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773138 ↗
• MalfunctionFeb 6, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING PROCEDURE, DURING THE SECOND ACTIVATION THE DEVICE WAS NOT ABLE TO OPEN AFTER CLOSE, SO THE SURGEON TRIED HARDER TO OPEN THE JAWS. A PHOTO WAS ATTACHED SHOWING A PART OF THE EXTERNAL JAW WAS BROKEN. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652514 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010013. One submission often covers many models, so check the product and lot details in each record.

• Z-0772-06 · Jan 27, 2006 · Terminated
  LigaSure Atlas Laparoscopic Vessel Sealer/Divider
• Z-0773-06 · Jan 27, 2006 · Terminated
  LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider