Endo GIA 030419Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10884523002966), received between May 15, 2017 and Dec 26, 2025 — classified as 12 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (19 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.

• MalfunctionDec 26, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO USE, AFTER LOADING THE RELOAD ON THE MANUAL HANDLE, THE INSTRUMENT COULD NOT BE OPENED AND WAS BLOCKED. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME APPLICATION KIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898333 ↗
• MalfunctionDec 18, 2025Misfire; Expulsion; Misfire; Expulsion

  IT WAS REPORTED THAT PREOPERATIVELY, THE RELOAD WAS CLOSED IN THE PACKAGE WHEN IT WAS SUPPOSED TO BE OPEN, AND THE STAPLES WERE ALREADY RELEASED IN THE RELOAD WITHOUT THE RELOAD HAVING BEEN USED. THE DEVICE WAS REPLACED WITH ANOTHER RELOAD TO FIX THE ISSUE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE LOADING UNIT WAS PARTIALLY FIRED. STAPLE PUSHERS WERE OBSERVED BETWEEN THE 2CM AND 1CM CUT LINES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842544 ↗
• MalfunctionJun 18, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLES WERE POORLY FORMED. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE AND TO REINFORCE THE STAPLE LINE.

  Patient problems: Tissue Breakdown

  MAUDE report 22284264 ↗
• MalfunctionJun 4, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON BUT COULD NOT SQUEEZE THE HANDLE, THE TWO HANDLES AND TWO RELOADS WERE UNABLE TO FIRE. A NEW POWER STAPLING SYSTEM AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146178 ↗
• MalfunctionJun 4, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON BUT COULD NOT SQUEEZE THE HANDLE, THE TWO HANDLES AND TWO RELOADS WERE UNABLE TO FIRE. A NEW POWER STAPLING SYSTEM AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146157 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT SURGERY ON CALL FOR A LAPAROSCOPIC APPENDECTOMY. THREE STAPLE MAGAZINES WERE USED DURING THE OPERATION, AT THE MOMENT IT WAS NOT POSSIBLE TO REPORT WHICH MAGAZINE CRASHED INTO THE MANUAL HANDLE. ACCORDING TO THE OPERATING ROOM NURSE AND THE SURGEON, THEY FOUND NOTHING ABNORMAL AT THE STAPLE LINE OR ANY FOREIGN MATERIAL IN THE ABDOMEN. 9 DAYS AFTER THE LAPAROSCOPIC APPENDECTOMY SURGERY, REOPERATION WAS DONE WHERE THE STAPLE LINE HAS RUPTURED. THERE WAS STAPLE LINE LEAK. CORRECTION OF STAPLING LINE BY SUTURES WAS MADE, DRAINAGE OF ABSCESS AND SEARCH FOR FOREIGN BODY WAS DONE TO RESOLVE THE ISSUE. IT WAS ALSO NOTED THAT FECALITIS WAS FOUND, WHICH INVOLVES THE DISTAL ILEUM AND THE CECAL POLE. NO FOREIGN MATERIAL CAN BE FOUND IN THE ABDOMEN.

  Patient problems: Abscess; Rupture; Tissue Breakdown

  MAUDE report 21398187 ↗
• MalfunctionFeb 10, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT FIRE. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341616 ↗
• MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING APPENDECTOMY, INVOLVING THE MANUAL HANDLE AND RELOAD. AFTER FIRING, THE SURGEON IDENTIFIED SMALL COMPONENTS IN THE SITUS, WHICH WERE SUSPECTED TO HAVE ORIGINATED FROM EITHER THE HANDLE OR THE LOADING UNIT. ALL COMPONENTS WERE REMOVED FROM THE SITUS AND SUBSEQUENTLY DISCARDED. THERE WERE NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096373 ↗
• MalfunctionSep 25, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE STAPLER DID NOT FIRE. A NEW INSTRUMENT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302220 ↗
• MalfunctionAug 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN APPENDECTOMY, THE FIRST RELOAD JUST PARTIALLY FIRED; THE SURGEON THEN TRIED WITH ANOTHER RELOAD, BUT THIS WOULD NOT FIRE AT ALL. A NEW APPENDECTOMY KIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036511 ↗
• MalfunctionAug 22, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING AN APPENDECTOMY, THE FIRST RELOAD JUST PARTIALLY FIRED; THE SURGEON THEN TRIED WITH ANOTHER RELOAD, BUT THIS WOULD NOT FIRE AT ALL. A NEW APPENDECTOMY KIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032372 ↗
• MalfunctionAug 22, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDLE DID NOT FIRE AND MADE A STRANGE NOISE. THE STAPLES OF THE RELOAD DID NOT DEPLOY; IT CUT BUT NO STAPLES. A NEW HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 20025120 ↗
• MalfunctionAug 20, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN APPENDECTOMY, THE STAPLES DID NOT DEPLOY. THE TISSUE WAS CUT BUT NO STAPLES. THE TISSUE WAS RESECTED AND RE-STAPLED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20004765 ↗
• MalfunctionJul 7, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THAT THE MANUAL STAPLER WAS NOT ABLE TO SQUEEZE THE HANDLE TO FIRE THE STAPLER. A NEW KIT WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686837 ↗
• MalfunctionMay 20, 2024Entrapment of Device; Failure to Form Staple; Entrapment of Device; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE KNIFE CAME BEFORE THE STAPLES. NOT ALL STAPLES FORMED AND THE KNIFE CANNOT BE RETRACTED. THE SURGEON USED A GRASPER TO REMOVE THE JAWS FROM THE TISSUE AND USED A NEW RELOAD WITH THE SAME HANDLE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19356487 ↗
• MalfunctionMay 20, 2024Entrapment of Device; Failure to Form Staple; Entrapment of Device; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, AT THE TIME OF STAPLING, THE KNIFE CAME BEFORE THE STAPLES. NOT ALL STAPLES FORMED AND THE KNIFE CANNOT BE RETRACTED. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19356444 ↗
• MalfunctionMay 16, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY, WHEN THE RELOAD WAS ATTACHED TO THE HANDLE AND CLOSED IT TO GET INTO THE TROCAR, IT DID NOT OPEN AGAIN WHEN THE SURGEON TRIED TO OPEN IT IN THE CAVITY. THE SURGEON THEN PULLED IN OUT AND TRIED TO ASSEMBLE AGAIN (THE JAWS WERE CLOSED BUT IT COULD BE REMOVE FROM THE HANDLE). THE SURGEON COULD NOT FIND A WAY TO OPEN THE JAWS OF THE RELOAD. A NEW RELOAD WAS THEN USED WITH THE SAME HANDLE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335654 ↗
• MalfunctionMay 15, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE STAPLER WAS RELEASED ON AN APPENDIX, THE HANDLE GOT LOCKED AND COULD NOT OPEN IT. THE USER TOOK IT OUT, BUT THE STAPLING HANDLE WAS STILL STOCKED. THERE WAS NO TISSUE INVOLVE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320614 ↗
• MalfunctionApr 25, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, AFTER THE SURGEON INSERTED THE DEVICE INTO THE TROCAR, THE JAWS OF THE DEVICE WOULD NOT OPEN. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182213 ↗
• MalfunctionApr 9, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, AFTER LOADING THE RELOAD, THE HANDLE WAS SQUEEZED, BUT THE JAWS DID NOT CLOSE AND RELEASED CORRECTLY. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075351 ↗
• InjuryApr 5, 2024Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS OF AN ANASTOMOSIS, DURING THE LAST SHOT TO FINISH MAKING THE RESERVOIR AT THE TOP OF THE STOMACH, THE RELOAD BROKE, BUT THE DEVICE DID NOT STOP. SHORTLY, AFTER STARTING THE SHOT, THE SURGEON NOTICED A CRACK AND THE CHARGE WAS FIRED IN ITS ENTIRETY, BUT THE STAPLES REMAINED OPENED; THE STAPLE LINE WAS INCOMPLETE CENTRALLY. SOME STAPLES AND THE TOP OF THE BLADE BROKE OFF AND FELL INTO PATIENT ABDOMINAL CAVITY. THE SURGEON REMOVED THE COMPONENTS WITH A LAPAROSCOPIC GRASPER. ADDITIONAL FOUR RELOADS OF THE SAME REFERENCE WAS USED WITH THE SAME HANDLE AND ADAPTER TO CUT A LITTLE MORE OF THE STONE ON THE PILLAR AND ON THE OTHER SIDE BEYOND THE EXCLUDED STOMACH THAT WAS DAMAGED. SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AND HOSPITALIZATION WAS EXTENDED FOR ONE MORE DAY.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19051660 ↗
• MalfunctionMar 14, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE JAWS OF THE DEVICE COULD NOT BE OPENED. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902936 ↗
• MalfunctionMar 13, 2024Retraction Problem; Misfire; Detachment of Device or Device Component; Retraction Problem; Misfire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, SOME STAPLES FROM THE RELOAD FELL INTO THE PATIENT'S ABDOMINAL CAVITY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899976 ↗
• MalfunctionDec 22, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, RESECTION OF THE APPENDIX, THE GREEN BUTTON WAS PRESSED AND THE BLACK RELEASE LEVER COULD NOT BE ACTUATED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18386492 ↗
• MalfunctionSep 11, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHILE RESECTIONING APPENDIX, THE HANDLE WITH THE RELOAD COULD NOT BE FIRED. THE SURGEON COULD PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE. ANOTHER RELOAD WITH THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725982 ↗

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-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-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-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-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-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-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-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-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-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-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT

…and 58 more.