Endo GIA EGIA45CTAVRecalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10884523003192), received between Aug 24, 2017 and Mar 30, 2026 — classified as 10 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (36 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PULMONARY SEGMENTECTOMY, DURING TRANSECTION OF THE PULMONARY VEIN, THERE WAS A POO R STAPLE FORMATION ON THE PROXIMAL END OF THE STAPLE LINE. ADDITIONALLY, BLEEDING WAS ALSO NOTED PROXIMALLY. TO RESOLVE THE ISSUE, REINFORCED STITCHING WITH THE SUTURE WAS PERFORMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24712557 ↗
• InjuryFeb 13, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, IMMEDIATELY AFTER STAPLING, A SMALL BLEEDING WAS OBSERVED AT THE DISTAL PORTION OF THE STAPLE LINE. THE PHYSICIAN PROMPTLY CLAMPED THE AREA WITH A SURGICAL CLAMP TO PREVENT FURTHER BLEEDING, FOLLOWED BY CONVERSION TO AN OPEN PROCEDURE. SUTURES WERE PLACED AT THE BLEEDING SITE. A NEW STAPLING WAS NOT POSSIBLE, AS THE REMAINING STUMP WAS TOO SMALL TO ACCOMMODATE ANOTHER STAPLER APPLICATION. THE SURGICAL TIME WAS EXTENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24330184 ↗
• MalfunctionJan 28, 2026Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, FIRING ISSUE OCCURRED WITH THE RELOAD COMPONENT. THE DEVICE WAS REPLACED WITH THE SAME PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206348 ↗
• MalfunctionDec 15, 2025Misfire; Misfire

  IT WAS REPORTED THAT AT THE MOMENT OF FIRING, THE DEVICE MALFUNCTIONED, RESULTING IN FIRING ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 23804780 ↗
• MalfunctionDec 11, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A SINGLE-PORT THORACOSCOPIC LOWER LOBECTOMY, THERE WAS POOR FORMATION OF DISTAL STAPLES AND AN INCOMPLETE STAPLE LINE AT THE DISTAL END. REINFORCED STITCHING WITH SUTURE WAS PERFORMED TO ADDRESS THE INCOMPLETE STAPLE LINE.

  Patient problems: Tissue Breakdown

  MAUDE report 23782252 ↗
• MalfunctionNov 3, 2025Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT DURING A SPLENECTOMY, THE STAPLES DID NOT DEPLOY, RESULTING IN A CUT BUT NO STAPLES. THE STAPLES WERE PRESENT IN THE CARTRIDGE. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT.

  Patient problems: Tissue Breakdown

  MAUDE report 23459510 ↗
• MalfunctionOct 29, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT PREOPERATIVELY, DURING SET-UP PRIOR TO FIRING, THE RELOAD DID NOT DEPLOY A STAPLE USING THE POWERED STAPLER. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417978 ↗
• MalfunctionAug 25, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A UNIPORTAL THORACOSCOPIC LOBECTOMY, THE STAPLER EXHIBITED POOR DISTAL STAPLE FORMATION AND INCOMPLETE DISTAL STAPLE LINES FOR ALL THREE RELOADS. REINFORCED SUTURE WITH THREAD WAS REQUIRED TO FIX THE INCOMPLETE STAPLE LINES.

  Patient problems: Tissue Breakdown

  MAUDE report 22888898 ↗
• MalfunctionMay 29, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE INSTRUMENT DID NOT FIRE. ANOTHER RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110093 ↗
• MalfunctionFeb 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN PERFORMING THE THIRD STAPLING, WHEN RELEASING, THE GREEN BUTTON WAS STUCK. THE LOAD WAS DISASSEMBLED AND REASSEMBLED, BUT THE PROBLEM PERSISTED. THE LOAD WAS CHANGED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21406899 ↗
• MalfunctionJan 8, 2025Retraction Problem; Misfire; No Apparent Adverse Event; Retraction Problem; Misfire; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON THE SECOND SHOT, THE LOAD DID NOT ADVANCE TO THE END OF THE STAPLING AND DID NOT RETRACT AND GOT STUCK. ALL POSSIBLE PROCEDURES WERE DONE, SUCH AS RESTARTING THE DEVICE, DISCONNECTING THE STEM, AN ATTEMPT TO REPLACE THE SHELL WAS ALSO DONE BUT IT WAS NOT SUCCESSFUL. TO COMPLETE THE PROCEDURE, A MANUAL STAPLER FROM A DIFFERENT MANUFACTURER WAS USED. THERE WAS NO ACTIVE BLEEDING DUE TO WHAT HAPPENED, BUT IT IMPACTED AN INCREASE OF THREE HOURS IN THE PROCEDURE. IT WAS NOTED, AFTER MANUAL STAPLING, THE USER REPLACED THE ROD WITH A NEW ONE, AND THE PROCEDURE CONTINUED WITHOUT COMPLICATIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 21107336 ↗
• MalfunctionJan 3, 2025Entrapment of Device; Retraction Problem; Misfire; Entrapment of Device; Retraction Problem; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IN THE SECOND SHOT, THE LOAD DID NOT ADVANCE TO THE END OF THE STAPLE, AND THE KNIFE DID NOT RETRACT AS WELL, LOCKING THE JAWS OF THE DEVICE TO THE TISSUE. ALL POSSIBLE SOLUTIONS HAVE BEEN DONE, SUCH AS RESTARTING THE HANDLE, DISCONNECTING THE ADAPTER, AND USING THE MANUAL RETRACTION TOOL. SHELL REPLACEMENT WAS ALSO ATTEMPTED, BUT ALL OF THESE DID NOT RESOLVE THE ISSUE. TO COMPLETE THE CASE, A MANUAL STAPLER FROM ANOTHER MANUFACTURER WAS USED. IT WAS NOTED THAT THE PROCEDURE WAS EXTENDED FOR MORE THAN THREE HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21073937 ↗
• MalfunctionOct 1, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE SETTING UP/PRIOR TO FIRING ISSUES, THE JAWS WOULD NOT CLOSE COMPLETELY. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE EGIA HANDLE HAD THICK TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346391 ↗
• MalfunctionJun 19, 2024Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PULMONARY LOBECTOMY PROCEDURE, WHEN THE SURGEON FINISHED STAPLING, THEY WERE UNABLE TO DISCONNECT THE RELOAD FROM THE ADAPTER. AFTER NUMEROUS ATTEMPTS, THE RELOAD BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571059 ↗
• MalfunctionJan 18, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LOBECTOMY, THE STAPLES DID NOT COME OUT WHEN FIRED.

  Patient problems: Insufficient Information

  MAUDE report 18538985 ↗
• InjuryOct 3, 2023Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A ROBOTIC LAPAROSCOPIC LOBECTOMY, THE JAWS OF THE DEVICE WAS LOCKED ON THE ARTERY. TROUBLESHOOTING WAS PERFORMED BUT THE ISSUE WAS NOT RESOLVED. THE ROD WAS DISCONNECTED AND CONNECT AGAIN. BOTH GREEN BUTTONS WERE PRESSED TO RESET THE DEVICE. THE MANUAL RETRACTION TOOL ALSO DID NOT WORK. THE MANUAL RETRACTION TOOL BROKE IN AN ATTEMPT TO OPEN THE RELOAD. THE MEDICAL TEAM TRIED TO UNLOCK IT FOR MORE THAN 30 MINUTES. THE ROBOTIC SURGERY WAS CONVERTED TO OPEN SURGERY TO REMOVE THE STAPLER.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 17865951 ↗
• MalfunctionSep 19, 2023Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE TWO RELOADS FIRED. HOWEVER, IT DID NOT INCISE THE TISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THE PROCEDURE WAS THEN CONVERTED INTO AN OPEN PROCEDURE UNRELATED TO THE DEVICE PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775736 ↗
• MalfunctionAug 31, 2023Entrapment of Device; Retraction Problem; Entrapment of Device; Retraction Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC THORACOSCOPIC PULMONARY MALIGNANT TUMOR SURGERY, DURING RIGHT SUPERIOR PULMONARY VEIN RESECTION, AFTER FIRING UNTIL THE TIP WITHOUT ANY PROBLEM, THE BLACK RETURN KNOB WAS PULLED AND WHEN THE KNIFE WAS PULLED, THE BLACK RETURN KNOB NO LONGER MOVED WITH A FEW MILLIMETERS LEFT. THE JAWS REMAINED FIXATED ON THE TISSUE, AND THE JAWS COULD NOT BE OPENED. THE ASSISTANT HELD THE SHAFT PART, THEN THE SURGEON HELD THE BLACK RETURN KNOB WITH BOTH HANDS AND WHEN IT WAS PULLED WITH CONSIDERABLE FORCE, THE JAWS SOMEHOW OPENED. THE SURGEON STATED THAT THERE WAS AN ABNORMAL STIFFNESS. A PRODUCT FROM ANOTHER COMPANY WAS USED AFTER SUPERIOR PULMONARY VEIN RESECTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667576 ↗
• MalfunctionJul 12, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, FOR THE FIRST RELOAD, THE STAPLER WAS ABLE TO FIRE, BUT THE STAPLE LINE WAS INCOMPLETE CENTRALLY. FAILED TO INCISION TISSUE. WHILE USING TWO RELOADS FROM ANOTHER LOT, THE STAPLER DID NOT FIRE. NEW PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17311432 ↗
• MalfunctionJul 12, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, FOR THE FIRST RELOAD, THE STAPLER WAS ABLE TO FIRE, BUT FAILED TO INCISION TISSUE. WHILE USING TWO RELOADS FROM ANOTHER LOT, THE STAPLER DID NOT FIRE. A NEW RELOAD WAS USED, REPLACING THE THREE RELOADS, AND SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17311353 ↗
• MalfunctionNov 23, 2022Failure to Form Staple; Human-Device Interface Problem; Failure to Form Staple; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN LUMBECTOMY PROCEDURE, THE STAPLE LINE WAS INCOMPLETE. ANOTHER STAPLE WAS PERFORMED USING THE SAME HANDLE TO RESOLVE THE ISSUE. IT WAS ALSO NOTED THAT THE RELOAD WAS DIFFICULT TO UNLOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15857983 ↗
• MalfunctionNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN HEPATECTOMY PROCEDURE, AFTER STAPLING IT WAS IDENTIFIED THAT THE STAPLE LINE DID NOT HOLD COMPLETELY. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755138 ↗
• MalfunctionApr 1, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A VIDEO-ASSISTED THORACIC SURGERY (VATS) PULMONARY LOBECTOMY, DURING THE PULMONARY ARTERY CLIPPING, THE RELOAD DID 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 13978142 ↗
• MalfunctionMar 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A VIDEO-ASSISTED THORACIC SURGERY (VATS) LOBECTOMY, AFTER FIRING, THE BLACK UNLOADING SLEEVE DETACHED FROM THE CARTRIDGE WHEN THE CARTRIDGE WAS REMOVED FROM THE HANDLE. ANOTHER HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13941148 ↗
• InjuryMar 18, 2022Misfire; Adverse Event Without Identified Device or Use Problem; Misfire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOBE HEPATECTOMY, A FEW MINUTES AFTER THE SURGEON STAPLED THE SUPERIOR LOBE HEPATIC VEIN, THERE WAS BLEEDING THAT WAS MORE THAN 500CC FROM THE STAPLE LINE AND NOTICED THAT ONLY 1/4 OF THE STAPLES HAD DEPLOYED FROM THE DEVICE. PATIENT HAD TO GET A BLOOD TRANSFUSION AND SURGICAL TIME WAS ALSO EXTENDED FOR ONE HOUR AND 30 MINUTES TO CONTROL THE BLEEDING WITH SUTURES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13806729 ↗

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-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-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-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-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-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-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-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-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-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-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-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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

…and 58 more.