Endo GIA EGIA45AVRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10884523003161), received between May 2, 2017 and Apr 17, 2026 — classified as 7 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (30 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825); 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Entrapment of Device

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC RADICAL NEPHRECTOMY, STAPLER WOULD NOT RELEASE FROM KIDNEY SIDE AFTER BEING DEPLOYED. SURGEON HAD TO CUT STAPLER OUT OF KIDNEY TISSUE TO GET KIDNEY AND DEVICE OUT OF PATIENT. UNEXPECTED OR PROLONGED CARE.

  Patient problems: Tissue Breakdown

  MAUDE report 24907302 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT PREOPERATIVELY, THE RELOAD BROKE. IT WAS NOTED THAT THE RELOAD WORKED WITH THE SAME STAPLER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733092 ↗
• MalfunctionMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAP ASSISTED LIVING DONOR NEPHRECTOMY PROCEDURE, THE DEVICE WAS USED. THERE WERE SPECIFIC ISSUES OF BLEEDING FROM THE STAPLE LINE THAT WAS CHALLENGING TO CONTROL, WHICH EXTENDED THE SURGICAL TIME BY 45 MINUTES. ADDITIONALLY, THERE WERE STAPLE LINE LEAKS, AND THE VEIN WAS STAPLED DURING THE PROCEDURE. A GENERAL SURGEON WAS CALLED IN TO ASSIST, AND A CLIP WAS PLACED BELOW THE STAPLE LINE TO CONTROL THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21643887 ↗
• MalfunctionDec 12, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A WEDGE RESECTION OF THE LUNG PROCEDURE, THE DEVICE WAS UNABLE TO FIRE SUCCESSFULLY. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915334 ↗
• MalfunctionOct 24, 2024Firing Problem; Firing Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON AND SQUEEZE THE HANDLE, BUT THE STAPLER DID NOT FIRE. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527395 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Firing Problem; Adverse Event Without Identified Device or Use Problem; Firing Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN RIGHT LIVER LOBECTOMY, WHEN THE HEPATIC VEIN WAS RESECTED, THE DEVICE WAS DIFFICULT TO FIRE BUT IT WAS ABLE TO BE FIRED. THE DEVICE WAS DETACHED FROM THE RESECTED BLOOD VESSEL AFTER STAPLING, THERE WAS AN EXCESSIVE HEMORRHAGING DURING LEFT HEPATIC LOBECTOMY WHEN THE MIDDLE AND LEFT ROOTS OF THE HEPATIC VEIN WERE TREATED ALL AT ONCE. BLOOD VESSEL WALL RUPTURED TO THE AREA NEAR INFERIOR VENA CAVA, AND A CARDIOVASCULAR SURGEON PERFORMED VASCULAR RECONSTRUCTION USING AN ARTIFICIAL HEART LUNG. MANUAL SUTURING WAS ALSO PERFORMED. THE CARDIAC ARREST TIME WAS 20 MINUTES. SURGICAL TIME WAS EXTENDED BY FOUR HOURS AND 42 MINUTES. CURRENTLY, THE PATIENT¿S CONDITION IS STABLE.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 20482035 ↗
• MalfunctionOct 10, 2024Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, STAPLING OF THE MESENTERY, RELOAD RETRACTION WAS UNUSUALLY SLOW. ONCE RETRACTED, THE RELOAD WOULD NOT BE UNARTICULATED. THE SURGEON HAD TO REMOVE THE TROCAR AND PULL THE UNARTICULATED RELOAD OUT OF THE PATIENT. A MANUAL RETRACTION TOOL WAS USED TO UNARTICULATED AND REMOVE TROCAR FROM RELOAD. WITH RELOAD STILL ATTACHED TO THE ADAPTOR, THE ADAPTOR WAS REMOVED FROM THE POWER HANDLE. WHEN PUT BACK ONTO THE POWER HANDLE, THE STILL STRAIGHT RELOAD ARTICULATED DURING ADAPTOR CALIBRATION, THEN INDICATING TO REMOVE RELOAD, BUT RELOAD COULD NOT BE REMOVED BECAUSE IT WAS ARTICULATED. THE RETRACTION TOOL WAS USED AGAIN TO STRAIGHTEN IT. THE RELOAD WAS THEN REMOVED FROM THE ADAPTOR. THE ADAPTOR WAS REASSEMBLED TO THE POWERED STAPLER AND CALIBRATED CORRECTLY. HOWEVER, THIS DEFECT RELOAD WOULD NOT ASSEMBLE. BACK ONTO THE ADAPTOR. FOR TESTING, ANOTHER USED RELOAD WAS SUCCESSFULLY PLACED ON THE ADAPTOR WITHOUT PROBLEM. LASTLY, THIS DEFECTIVE RELOAD WAS AGAIN PLACED ONTO THE ADAPTOR SUCCESSFULLY WITHOUT PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417726 ↗
• MalfunctionJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC AND OPEN NEPHROURETERECTOMY WITH RESECTION OF BLADDER CUFF AND REGIONAL LYMPH NODE DISSECTION, DURING ARTERY LIGATION, THERE WAS STAPLE LINE BLEEDING. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE TO CONTROL THE BLEEDING BOTH DURING THE LAPAROSCOPIC PORTION AND OPEN PROCEDURE PORTION. THE ISSUE OCCURRED ON A TOTAL OF SIX RELOADS. CLIPS AND SEALANT FROM ANOTHER MANUFACTURER WERE USED TO STOP THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18431009 ↗
• MalfunctionJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC AND OPEN NEPHROURETERECTOMY WITH RESECTION OF BLADDER CUFF AND REGIONAL LYMPH NODE DISSECTION, DURING ARTERY LIGATION, THERE WAS STAPLE LINE BLEEDING. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE TO CONTROL THE BLEEDING BOTH DURING THE LAPAROSCOPIC PORTION AND OPEN PROCEDURE PORTION. THE ISSUE OCCURRED ON A TOTAL OF SIX RELOADS. CLIPS AND SEALANT FROM ANOTHER MANUFACTURER WERE USED TO STOP THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18430880 ↗
• MalfunctionSep 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC CHOLECYSTECTOMY, THE DISPOSABLE YELLOW PART CONNECTED TO SLIT OF STAPLER WAS REMOVED PRIOR TO USE; HOWEVER, WHILE THE STAPLER WAS BEING USED BY THE SURGEON, FRAGMENTS OF THE YELLOW PART BROKE OFF AND FELL INTO THE PATIENT'S CAVITY. ALL FRAGMENTS WERE RETRIEVED BY THE SURGEON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741019 ↗
• MalfunctionJun 15, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY, WHEN THE DOCTOR WAS ATTEMPTING TO FIRE THE STAPLE LOAD ACROSS THE APPENDIX, THE STAPLE LOAD WOULD NOT FIRE. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137344 ↗
• MalfunctionMay 24, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE USER WAS ABLE TO PRESSED THE GREEN BUTTON BUT COULD NOT SQUEEZED THE HANDLE. THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995495 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC APPENDECTOMY, THE PATIENT RETURNED TO THE HOSPITAL AND WAS ADMITTED THROUGH THE EMERGENCY ROOM FOR ABDOMINAL PAIN. DURING EXPLORATION OF ABDOMINAL CAVITY DURING LAPAROSCOPIC SURGERY WITH RIGHT HEMICOLECTOMY, THE SURGEON SUCTIONED OUT THE PUS AND FLUIDS WHICH IS THE RESULT OF DEHISCENCE OBSERVED AT THE STAPLE LINE OF THE APPENDIX.

  Patient problems: Fluid Discharge

  MAUDE report 13772759 ↗
• MalfunctionOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN COLECTOMY, THE STAPLER WAS ABLE TO FIRE, HOWEVER, WHEN THE DEVICE WAS REMOVED, THE STAPLE LINE WAS FOUND OPEN. TO RESOLVE THE ISSUE, THE TISSUE WAS RE-STAPLED. A NEW RELOAD WAS OPENED AND USED TOGETHER WITH THE SAME HANDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689326 ↗
• MalfunctionOct 21, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHILE FIRING ON THE MESENTERY, THE RELOAD ONLY PARTIALLY FIRED AND STOPPED AT 5-10MM IN THE NON THICK MESENTERY. THE USER RETRACTED THE RELOAD THEN ANOTHER CARTRIDGE AND THE SAME HANDLE, SHELL AND ADAPTER WERE USED AND COMPLETED THE FIRING IN ZONE 1 TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673646 ↗
• MalfunctionOct 18, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN STAPLING ANASTOMOSIS DURING A LAPAROSCOPIC GASTRIC BYPASS, THE STAPLER FIRED BUT A YELLOW COMPONENT BROKE AND FELL INTO THE PATIENT¿S CAVITY. THE YELLOW SPECK WAS ALSO RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647074 ↗
• MalfunctionAug 9, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING RESECTION OF BLOOD VESSEL IN A THORACOSCOPIC LOBECTOMY OF LUNG, FIRING STOPPED MIDWAY. RESECTION COULD ONLY BE PERFORMED HALFWAY THROUGH THE BLOOD VESSEL, SO ADDITIONAL FIRING WAS PERFORMED WITH A NEW CARTRIDGE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294229 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS ROUX-N-Y, WHILE STAPLING THE MESENTERY, THE STAPLER WAS ABLE TO FIRE BUT THE STAPLE LINE WAS BLEEDING. THE CLIP APPLIER WAS PULLED AND THE BLEEDING STAPLE LINE WAS CLIPPED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11965909 ↗
• InjuryMay 3, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVER RESECTION, THE RIGHT HEPATIC ARTERY WAS TO BE DETACHED, AND 45 GRAY STAPLE WAS USED. AFTER A NORMAL FIRING, THE STAPLES WERE POORLY FORMED, AND THE BLOOD VESSELS WERE NOT STAPLED. THE STAPLE LINE WAS ALSO INCOMPLETE DISTALLY. SUTURES WERE USED FOR HEMOSTASIS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11761235 ↗
• MalfunctionFeb 23, 2021Misfire; Human-Device Interface Problem; Misfire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE SALES REPRESENTATIVE CANNOT REMOVE RELOAD FROM ADAPTER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369098 ↗
• MalfunctionNov 30, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING PANCREATICODUODENECTOMY, THE DEVICE ENTERED FIRING MODE, BUT COULD NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10918030 ↗
• MalfunctionOct 20, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SPLENECTOMY, WHEN RELOAD WAS LOADED, IT WAS UNABLE TO BE FIRED ON TISSUE. RELOAD WAS UNLOADED AND THE HANDLE WAS REPLACED WITH A NEW ONE, BUT STILL UNABLE TO BE FIRED. A NEW RELOAD WAS OPENED, LOADED AND WAS SUCCESSFULLY USED ON TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10705379 ↗
• MalfunctionSep 16, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THORACO/LOBECTOMY, THE SURGEON COULD NOT FIRE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10539145 ↗
• MalfunctionSep 11, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, AT THE TREATMENT OF THE VESSEL DURING A LOBECTOMY PROCEDURE, THE DEVICE COULD NOT BE FIRED. IT WAS STATED THAT THERE HAD BEEN NO PROBLEM IN OPENING, OR CLOSING CHECK. THE PROCEDURE WAS COMPLETED WITH ANOTHER RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10519752 ↗
• MalfunctionMar 29, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC APPENDECTOMY, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE BUT THE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9896260 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825. One submission often covers many models, so check the product and lot details in each record.

• Z-0747-2021 · Nov 23, 2020 · Completed
  Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or tra
• Z-0748-2021 · Nov 23, 2020 · Completed
  Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection
• Z-0009-2021 · Aug 12, 2020 · Open, Classified
  Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applicat
• Z-0003-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0001-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gyn
• Z-0005-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric
• Z-0006-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0004-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0002-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0008-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0007-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic
• Z-1264-2020 · Jan 17, 2020 · Terminated
  Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT

…and 58 more.