Endo GIA EGIA60AXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 987 adverse event reports that list this exact device (DI 10884523003253), received between Feb 2, 2017 and Sep 29, 2026 — classified as 4 deaths, 78 injuries, 905 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (524 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 987 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Misfire

  It was reported during a procedure that, after firing approximately half of the reload, the remaining portion failed to fire. To resolve the issue, a competitor's manual stapler was used to complete the procedure. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934685 ↗
• MalfunctionSep 29, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934559 ↗
• MalfunctionSep 29, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934209 ↗
• MalfunctionSep 29, 2026Misfire

  According to the reporter during procedure, one manual handle and three reloads were defective. It appeared that all three reloads had been used due to a handle-related issue. It was found that the handle did not complete the firing cycle. No patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934150 ↗
• MalfunctionSep 29, 2026Misfire

  According to the reporter during procedure, one manual handle and three reloads were defective. It appeared that all three reloads had been used due to a handle-related issue. It was found that the handle did not complete the firing cycle. No patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934104 ↗
• MalfunctionSep 28, 2026Mechanics Altered

  Patient problems: Tissue Breakdown

  MAUDE report 50926396 ↗
• MalfunctionAug 27, 2026Failure to Fire

  It was reported that during the procedure, the device 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 50484908 ↗
• MalfunctionAug 14, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263004 ↗
• MalfunctionAug 3, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50114294 ↗
• MalfunctionAug 3, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50114264 ↗
• MalfunctionJun 29, 2026Firing Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE RELOAD WAS DIFFICULT TO FIRE AND THE FIRING WAS NOT COMPLETED. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.`

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

  MAUDE report 25660864 ↗
• MalfunctionMay 12, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING THE PROCEDURE, THE INSTRUMENT DID NOT FIRE. THE DEVICE WAS REPLACED WITH A MANUAL STAPLER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153990 ↗
• MalfunctionMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL GASTRECTOMY FOR GASTRIC CANCER, THE TISSUE OOZING BLOOD FOLLOWING ANASTOMOSIS WHILE TRANSECTING THE GASTRIC BODY AND MANUAL SUTURING WAS PERFORMED TO COMPLETE THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25076656 ↗
• MalfunctionApr 23, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY, TWO RELOADS WERE USED WHILE TRANSECTING THE LUNG TISSUE AND POOR STAPLE FORMATION WAS OBSERVED. THE CARTRIDGE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24968546 ↗
• MalfunctionApr 20, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE ATTEMPTING TO GRASP TISSUE WITH THE STAPLER, THE INSTRUMENT JAW DID NOT FULLY CLOSE AND THE HANDLE PRESENTED UNUSUAL RESISTANCE WHEN ATTEMPTING TO ACTUATE IT. UPON APPLYING ADDITIONAL FORCE TO COMPLETE THE CLOSURE, THE USER REPORTED HEARING AN INTERNAL SOUND CONSISTENT WITH A POSSIBLE FRACTURE OF A COMPONENT INSIDE THE INSTRUMENT. THE USER THEN ATTEMPTED TO PERFORM ANOTHER TISSUE GRASP ON THINNER TISSUE; HOWEVER, THE STAPLER COULD NO LONGER BE ACTUATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932119 ↗
• MalfunctionApr 13, 2026Misfire; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING USE, THE DEVICE HAD AN UNKNOWN ISSUE. THE DEVICE WAS REPLACED WITH A NEW PRODUCT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED.

  Patient problems: Insufficient Information

  MAUDE report 24860787 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A GASTRIC SLEEVE SURGERY, A NEGATIVE INTRAOPERATIVE LEAK TEST WAS OBTAINED. ONE WEEK POST-OPERATION, LEAKAGE AT THE STAPLE LINE WAS DETECTED AFTER THE PATIENT PRESENTED WITH PAIN. EXTENDED HOSPITALIZATION WAS REQUIRED, AND A PIGTAILCATHETER WAS INSTALLED TO ADDRESS THE LEAK. THE PATIENT IS ALIVE AND RECOVERING WELL.

  Patient problems: Pain

  MAUDE report 24796116 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WEEK FOLLOWING A GASTRIC SLEEVE PROCEDURE, A LEAK OF CONTENTS BEING HELD BY TISSUE WAS DISCOVERED. THE PATIENT PRESENTED WITH PAIN, WHICH LED TO THE IDENTIFICATION OF THE STAPLE LINE LEAK. EXTENDED HOSPITALIZATION WAS REQUIRED, AND A DRAIN WAS INSTALLED TO ADDRESS THE COMPLICATION, RESOLVING THE ISSUE WITHOUT MAJOR PROCEDURES.

  Patient problems: Pain; Tissue Breakdown

  MAUDE report 24757504 ↗
• MalfunctionMar 31, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN SETTING UP, THE RELOAD WAS ABLE TO BE LOADED BUT IT COULD NOT BE FIRED. THE DEVICE WAS REPLACED WITH A NEW RELOAD TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749449 ↗
• MalfunctionMar 31, 2026Misfire; Firing Problem

  IT WAS REPORTED THAT DURING USE OF THE POWERED STAPLER, THE RELOAD WAS DIFFICULT TO FIRE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742813 ↗
• MalfunctionMar 25, 2026Difficult to Open or Close; Fail-Safe Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC TOTAL GASTRECTOMY WITH ROUX-EN-Y, AFTER THE 6TH  FIRING, THE SCRUB NURSE TRIED TO OPEN THE RELOAD OUTSIDE OF THE PATIENT TO LOAD A NEW RELOAD. THE BLACK PULL-BACK KNOBS WERE PULLED BUT THE RELOAD WOULD NOT OPEN AND THEREFORE COULD NOT BE UNLOADED. THE RELOAD WAS FIRED AGAIN OUTSIDE THE PATIENT AND THE SCRUB NURSE PULLED BACK THE BLACK KNOBS TO RETRY TO OPEN THE JAWS, BUT WAS STILL UNSUCCESSFUL. 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 24689458 ↗
• MalfunctionMar 18, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC DISTAL PANCREATECTOMY FOR RESECTION OF THE PANCREATIC BODY AND TAIL, THE STAPLER FAILED TO FIRE PROPERLY. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. IT WAS NOTED THAT TWO MANUAL HANDLES AND ONE RELOAD WERE USED THAT HAD THE SAME ISSUE. THE STAPLER WAS REPLACED BY ANOTHER MANUFACTURER'S HANDLE AND RELOAD TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631571 ↗
• MalfunctionMar 17, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR HANDLES AND TWO RELOADS FAILED TO FIRE, EVEN THOUGH THE USER HAD CLICKED THE GREEN BUTTON BEFORE FIRING. AFTER CLICKING THE GREEN BUTTON, THE HANDLE WAS STUCK AND UNABLE TO MOVE. THE DOCTOR HAD TO SWITCHED TO A DIFFERENT BRAND TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615076 ↗
• MalfunctionMar 12, 2026Failure to Form Staple; Noise, Audible

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY OF THE LEFT UPPER LOBE, A CLICKING SOUND WAS HEARD FROM THE DEVICE WHEN TRYING TO DETACH THE BRONCHUS. THE FRONT PART OF THE GRIP REACTED WHEN PRESSED, AND THEN THE HANDLE IDLED AFTER HEARING A CLICK, AND A PART OF THE STAPLER APPEARED UNFORMED. AN INCOMPLETE STAPLE LINE WAS OBSERVED DISTALLY. THE SURGEON REPLACED THE HANDLE AND RELOAD TO COMPLETE THE SURGERY.

  Patient problems: Tissue Breakdown

  MAUDE report 24582310 ↗
• MalfunctionMar 6, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT UPPER LOBECTOMY, AFTER THE THE STAPLER WAS INSTALLED, THE HANDLE COULD NOT BE TEST-FIRED AFTER REMOVING THE SAFETY WEDGE, AND THE JAWS COULD NOT BE CLOSED. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528552 ↗

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-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-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-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-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-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-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-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-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-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT

…and 58 more.