Endo GIA EGIA45AXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 10884523003185), received between Aug 4, 2017 and Aug 11, 2026 — classified as 17 injuries, 208 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (139 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 225 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Failure to Fire

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

  MAUDE report 50201538 ↗
• MalfunctionJun 8, 2026Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER DID NOT FIRE. THE STAPLES WERE STUCK. A NEW SHELL AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427270 ↗
• MalfunctionMay 4, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AFTER FIRING THE RELOAD, THE STAPLE LINE LEAKED THE CONTENTS BEING HELD BY THE TISSUE. THE LEAK TEST RETURNED POSITIVE. THE ISSUE HAPPENED WITH THREE RELOADS. ANOTHER DEVICE WAS USED TO RE-STAPLE THE LEAKING STAPLE LINE TO RESOLVE THE ISSUE

  Patient problems: Tissue Breakdown

  MAUDE report 25076207 ↗
• MalfunctionMar 30, 2026Misfire

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, PRIOR TO PATIENT CONTACT, THE ROD WAS STUCK AND BROKEN, AND THE RELOAD PLACED ON IT WOULD ONLY ADVANCE TO THE HALFWAY POINT AND STOPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727478 ↗
• MalfunctionMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE STAPLE LINE DID NOT HOLD. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24709459 ↗
• MalfunctionFeb 13, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A SINGLE-PORT THORACOSCOPIC RIGHT UPPER LOBECTOMY AT THE STEP OF DETACHMENT OF THE RIGHT UPPER LUNG LOBE, THE DEVICE DID NOT FIRE. THE HANDLE AND RELOAD WERE REPLACED WITH NEW ONES 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 24332130 ↗
• MalfunctionFeb 6, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE SINGLE-PORT THORACOSCOPIC RIGHT UPPER LOBECTOMY, WHEN ON THE LUNG LOBE DETACHMENT, THE STAPLER WAS UNABLE TO FIRE. BOTH THE HANDLE AND RELOAD WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284046 ↗
• MalfunctionJan 28, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A VATS (VIDEO-ASSISTED THORACIC SURGERY) LOBECTOMY, THE JAWS WOULD NOT CLOSE COMPLETELY. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202665 ↗
• MalfunctionJan 13, 2026Failure to Read Input Signal; Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RELOAD WAS NOT RECOGNIZED. THE DEVICE WAS REPLACED WITH A NEW RELOAD. 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 24055708 ↗
• MalfunctionJan 2, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE SINGLE-PORT THORACOSCOPIC LOBECTOMY, AFTER FIRING, BOTH RELOADS HAVE POOR STAPLE FORMATION AND THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE SURGEON REINFORCED MANUAL STITCHING TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23951533 ↗
• MalfunctionOct 22, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE LYMPHADENECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON AND SQUEEZE THE HANDLE BUT THE RELOAD COULD NOT BE FIRED. THE DEVICE WAS REPLACED WITH ANOTHER RELOAD FROM ANOTHER BATCH TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359352 ↗
• MalfunctionOct 20, 2025Misfire; Failure to Cut; Failure to Fire; Misfire; Failure to Cut; Failure to Fire

  IT WAS REPORTED THAT DURING A SINGLE-PORT THORACOSCOPIC PULMONARY WEDGE RESECTION WITH LOBECTOMY, THE STAPLER FAILED TO FIRE. THE STAPLER WAS REPLACED WITH A NEW RELOAD TO COMPLETE THE CASE. THERE WAS NO PATENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344235 ↗
• MalfunctionAug 21, 2025Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE LOCK RING OF THE RELOAD WAS BROKEN AND NOT COMPLETELY CLOSED. ANOTHER RELOAD WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865859 ↗
• MalfunctionMay 30, 2025Break; Entrapment of Device; Retraction Problem; Break; Entrapment of Device; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LOW ANTERIOR RESECTION, THE DEVICE FAILED, PROMPTING THE SURGICAL TEAM TO SWITCH TO THE POWERED STAPLER WITH A BLACK RELOAD CARTRIDGE. WHILE USING THE POWERED STAPLER, THE RELOAD MALFUNCTIONED, CEASING TO FUNCTION AND BECOMING UNRESPONSIVE DURING AN ATTEMPT TO RETRACT THE KNIFE BLADE. DESPITE FOLLOWING THE TROUBLESHOOTING GUIDE AND ATTEMPTING MANUAL RETRACTION, THE RELOAD REMAINED LOCKED ON THE TISSUE. THE ARTICULATION JOINT OF THE RELOAD WAS LATER FOUND TO BE BROKEN. THEY HAD TO USE ANOTHER INSTRUMENT TO SEPARATE THE RELOAD FROM THE TISSUE. THE SURGERY WAS COMPLETED USING DIFFERENT STAPLER TO RESECT AND RE-STAPLE, AND SUTURING WAS DONE AS A STAPLE LINE REINFORCEMENT.

  Patient problems: Tissue Breakdown

  MAUDE report 22119856 ↗
• MalfunctionApr 16, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A BARIATRIC SLEEVE VL SURGERY, THE RELOAD DID NOT FIRE. THE 45 MILLIMETER LOAD WAS REPLACED WITH ANOTHER ONE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE NOTED, AND THE PATIENT REMAINED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846429 ↗
• MalfunctionMar 5, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT LOBECTOMY, WHEN DETACHING THE LUNG LOBE TISSUE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON HOWEVER THE HANDLE COULD NOT BE SQUEEZED, THE DEVICE WAS NOT ABLE TO FIRE. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531816 ↗
• MalfunctionMar 4, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION (LAR) PROCEDURE, WHEN THE FIRST 45AXT DEVICE WAS USED TO DETACH THE RECTUM, THE STAPLE BURST OUT AND DID NOT FORM A PROPER B-SHAPE. THIS RESULTED IN BLEEDING, AND WAS SUTURED MANUALLY. SUBSEQUENT FIRINGS CONTINUED WITH TWO NEW 45AXT DEVICES, WHEN FIRING, THE HANDLE COULD NOT BE PRESSED. THE FIRST HANDLE, WHICH HAD BEEN USED WHEN THE PREVIOUS STAPLES BURST OUT, WAS TRIED FIRST, BUT THE DEVICE STILL COULD NOT BE FIRED AFTER REPLACING IT WITH A NEW HANDLE. BOTH HANDLES COULD NOT BE PRESSED. AFTER REPLACING THE HANDLE AND RELOAD, FIRING WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521134 ↗
• MalfunctionMar 4, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION (LAR) PROCEDURE, WHEN THE FIRST 45AXT DEVICE WAS USED TO DETACH THE RECTUM, THE STAPLE BURST OUT AND DID NOT FORM A PROPER B-SHAPE. THIS RESULTED IN BLEEDING, AND WAS SUTURED MANUALLY. SUBSEQUENT FIRINGS CONTINUED WITH TWO NEW 45AXT DEVICES, WHEN FIRING, THE HANDLE COULD NOT BE PRESSED. THE FIRST HANDLE, WHICH HAD BEEN USED WHEN THE PREVIOUS STAPLES BURST OUT, WAS TRIED FIRST, BUT THE DEVICE STILL COULD NOT BE FIRED AFTER REPLACING IT WITH A NEW HANDLE. BOTH HANDLES COULD NOT BE PRESSED. AFTER REPLACING THE HANDLE AND RELOAD, FIRING WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521114 ↗
• MalfunctionMar 4, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION (LAR) PROCEDURE, WHEN THE FIRST 45AXT DEVICE WAS USED TO DETACH THE RECTUM, THE STAPLE BURST OUT AND DID NOT FORM A PROPER B-SHAPE. THIS RESULTED IN BLEEDING, AND WAS SUTURED MANUALLY. SUBSEQUENT FIRINGS CONTINUED WITH TWO NEW 45AXT DEVICES, WHEN FIRING, THE HANDLE COULD NOT BE PRESSED. THE FIRST HANDLE, WHICH HAD BEEN USED WHEN THE PREVIOUS STAPLES BURST OUT, WAS TRIED FIRST, BUT THE DEVICE STILL COULD NOT BE FIRED AFTER REPLACING IT WITH A NEW HANDLE. BOTH HANDLES COULD NOT BE PRESSED. AFTER REPLACING THE HANDLE AND RELOAD, FIRING WAS SUCCESSFULLY COMPLETED.

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

  MAUDE report 21521112 ↗
• MalfunctionFeb 26, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC DISTAL PANCREATECTOMY, THE STAPLER HAD DIFFICULTY IN OPENING AND CLOSING THE JAW. THE DEVICE WAS REPLACED WITH A NEW HANDLE TO RESOLVE THE ISSUE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THERE WAS EGIA RELOAD THICK TISSUE. THE CLAMPING MECHANISM WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21473183 ↗
• MalfunctionJan 30, 2025Misfire; Firing Problem; Misfire; Firing Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT THE DEVICE PARTIALLY FIRED WITH THE INTERLOCK ENGAGED. THE STAPLE PUSHERS WERE VISIBLE AT THE 2CM CUT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273936 ↗
• MalfunctionJan 24, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 21235822 ↗
• MalfunctionJan 20, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LEFT UPPER LOBECTOMY PROCEDURE, THE RELOAD WAS USED TO DETACH THE INTERLOBAR FISSURE, AND THE STAPLES BURST OUT AND DID NOT FORM A GOOD B SHAPE, AND THERE WAS BLEEDING. AFTER PRESSING WITH GAUZE, THE LUNG PARENCHYMA WAS RE-DETACHED AFTER REPLACEMENT OF THE NEW HANDLE AND STAPLE AT THE ADJACENT POSITION TO STOP THE BLEEDING IMMEDIATELY AND FINALLY THE OPERATION WAS COMPLETED. THE INCISION WAS EXTENDED DUE TO THE PRODUCT PROBLEM.

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

  MAUDE report 21191141 ↗
• MalfunctionJan 2, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PULMONARY LOBECTOMY, WHEN CLAMPING THE LUNG LOBE, IT POPPED WHEN BEING FIRED WHEN THE HANDLE WAS USED. IT WAS NOTED THAT THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE, AND THE STAPLER DID NOT FIRE, AND IT OCCURRED ON TWO RELOADS. A NEW DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21058169 ↗
• MalfunctionJan 2, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PULMONARY LOBECTOMY, WHEN CLAMPING THE LUNG LOBE, IT POPPED WHEN BEING FIRED WHEN THE HANDLE WAS USED. IT WAS NOTED THAT THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE, AND THE STAPLER DID NOT FIRE, AND IT OCCURRED ON TWO RELOADS. A NEW DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057906 ↗

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-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-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-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-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-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-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-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-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

…and 58 more.