LigaSure AtlasRecalls & reported problems across all models

We found 2 models of LigaSure Atlas by Covidien LP in the FDA's device registry (GUDID). Together they are named in 396 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2016 and Sep 17, 2026 — classified as 1 death, 41 injuries, 354 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (167 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported LigaSure Atlas problems

LigaSure Atlas models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LigaSure Atlas LS1037

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 death254 reports
• LigaSure Atlas LS1020

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  142 reports

Recent LigaSure Atlas adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Self-Activation or Keying

  It was reported that, during procedure, the device had activated without the activation button being pushed. Another handpiece was used with the same generator and it worked fine. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798049 ↗
• 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 ↗
• MalfunctionFeb 24, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE WITH A USE OF THE LS1020 LIGASURE ATLAS HANDSWITCH 20CM DEVICE, THE JAW WAS DIFFICULT OR IMPOSSIBLE TO OPEN. IT WAS NOT STUCK ON TISSUE. THE DEVICE WAS PLUGGED INTO A GENERATOR AT THE TIME OF THE EVENT. THE DEVICE WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431557 ↗
• 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 26, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION SURGERY, THE HANDPIECE BUTTON WAS STUCK IN THE ON POSITION, CONTINUING TO ACTIVATE. A NEW HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892547 ↗
• 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 24, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT ABOUT 15 MINUTES OF AN OPEN EXPLORATORY LAPAROTOMY WITH BOWEL RESECTION AND OSTOMY, THE DEVICE¿S JAWS GOT STUCK AND NOT OPENING. SWAPPED OUT FOR A FRESH DEVICE AND THE UNIT PROCEEDED WITHOUT INCIDENT. THE KNIFE BLADE WAS NOT EXTENDED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22601147 ↗
• MalfunctionJul 10, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A BILATERAL ADNEXECTOMY, THE JAWS OF THE HANDPIECE CLAMPS BECAME STUCK WHILE BEING USED ON THE PATIENT'S TISSUE. IT WAS NOT STUCK ON TISSUE BUT IT WAS IMPOSSIBLE TO REOPEN THE CLAMP USING THE STANDARD HANDLE. IT WAS CLEANED NORMALLY. THE KNIFE BLADE WAS NOT EXTENDED NOR PROTRUDED BEYOND THE EDGE OF THE JAWS. A NEW CLAMP WAS USED, BUT THE PROBLEM RECURRED. A THIRD HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467503 ↗
• MalfunctionJul 10, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A BILATERAL ADNEXECTOMY, THE JAWS WAS IMPOSSIBLE TO UNCLAMP FROM THE TISSUE USING THE STANDARD HANDLE. IT WAS CLEANED NORMALLY. THE KNIFE BLADE WAS NOT EXTENDED NOR PROTRUDED BEYOND THE EDGE OF THE JAWS. A NEW CLAMP WAS USED, BUT THE PROBLEM RECURRED. A THIRD HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467502 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall