Endo GIA EGIA45CTAVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 405 adverse event reports that list this exact device (DI 10884523003208), received between Apr 28, 2017 and Sep 29, 2026 — classified as 2 deaths, 36 injuries, 367 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (259 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 405 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Form Staple

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50933814 ↗
• MalfunctionSep 22, 2026Failure to Fire

  According to the reporter, intra-operatively, the reload did not fire. Another reload was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850015 ↗
• MalfunctionAug 25, 2026Unintended Ejection; Expulsion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437723 ↗
• MalfunctionApr 3, 2026Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TWO RELOADS WERE FAILED DURING USE. THE DEVICE WAS REPLACED BY CHANGING TO A NEW PRODUCT 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 24783804 ↗
• MalfunctionApr 3, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY, WHILE DETACHING A BLOOD VESSEL, THE STAPLER WAS REPORTEDLY NOT ABLE TO FIRE, AND THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE, ALTHOUGH THE GREEN BUTTON COULD BE PRESSED. THE DEVICE WAS REPLACED WITH A PRODUCT FROM ANOTHER MANUFACTURER 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 24783452 ↗
• MalfunctionApr 3, 2026Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TWO RELOADS WERE FAILED DURING USE. THE DEVICE WAS REPLACED BY CHANGING TO A NEW PRODUCT 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 24782997 ↗
• MalfunctionMar 16, 2026Misfire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE RELOAD FAILED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613237 ↗
• MalfunctionMar 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LUNG RESECTION SURGERY (THORACOSCOPIC SURGERY) FOR DETACHING A BLOOD VESSEL, THE DEVICE DID NOT FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE HANDLE AND RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551537 ↗
• MalfunctionMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLE LINE DID NOT HOLD AND SUBSEQUENTLY OPENED UP AFTER COMPLETE FIRING. IT OCCURRED ON TWO RELOADS. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24523697 ↗
• MalfunctionMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLE LINE DID NOT HOLD AND SUBSEQUENTLY OPENED UP AFTER COMPLETE FIRING. IT OCCURRED ON TWO RELOADS. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24523675 ↗
• MalfunctionMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLE LINE DID NOT HOLD OR THE STAPLE LINE OPENED UP AFTER COMPLETE FIRING. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24500689 ↗
• MalfunctionFeb 11, 2026Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311051 ↗
• MalfunctionJan 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, THE RELOAD INTELLIGENCE CHIP BROKE OFF. IT COULD NOT BE USED EVEN AFTER CONNECTING IT TO THE ADAPTER. TO RESOLVE THE ISSUE, A NEW RELOAD OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190791 ↗
• MalfunctionJan 22, 2026Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE AFTER FIRING, THE STAPLE LINE DID NOT HOLD AND SUBSEQUENTLY OPENED UP. IT OCCURRED ON TWO RELOADS. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24150016 ↗
• MalfunctionJan 14, 2026Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER FIRING, THE STAPLES DID NOT COME OUT OF THE CARTRIDGE AND ONTO THE TISSUE. IT OCCURRED ON TWO RELOADS. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24064501 ↗
• MalfunctionJan 13, 2026Misfire; Firing Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE POWERED STAPLER 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 RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055646 ↗
• MalfunctionJan 9, 2026Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY, THE RELOAD EXPERIENCED COMPONENT DETACHMENT, SPECIFICALLY THE BLACK COMPONENT AT THE CONNECTION POINT WITH THE HANDLE, AND THERE WAS A PROBLEM UNLOADING THE DEVICE. IT WAS ALSO REPORTED THAT A DEVICE COMPONENT BROKE OFF, BUT THE COMPONENT DID NOT FALL INTO THE PATIENT CAVITY. THE ISSUE OCCURRED DURING THE STEP WHEN THE RELOAD WAS BEING REPLACED. THE DEVICE WAS REPLACED 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 24020896 ↗
• MalfunctionJan 6, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE SO BOTH, HANDLE AND RELOAD DID NOT FIRE. TO RESOLVE THE ISSUE, BOTH THE HANDLE AND RELOAD WERE REPLACED 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 23971404 ↗
• MalfunctionJan 3, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING LUNG RESECTION, THE FIRST RELOAD WAS DIFFICULT TO FIRE. THE OTHER RELOAD WAS NOTED TO HAVE A JAW THAT DID NOT COMPLETELY CLOSE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952796 ↗
• MalfunctionDec 30, 2025Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY, THE HANDLE AND RELOAD WERE USED TO TRANSECT THE PATIENT'S PULMONARY VEIN. THE SURGEON PRESSED THE GREEN FIRING BUTTON AND SQUEEZED THE BLACK HANDLE; STAPLER STOPPED FIRING HALFWAY THROUGH AND COULD NOT CONTINUE TO FIRE THE RELOAD, A CLICKING SOUND WAS HEARD, BUT FURTHER PRESSING OF THE HANDLE PRODUCED NO RESPONSE, INDICATING THE DEVICE WAS UNABLE TO FIRE. ADDITIONALLY, AN INCOMPLETE STAPLE LINE WAS OBSERVED AT THE DISTAL END. THE ISSUE WAS RESOLVED BY USING A NEW STAPLER AND RELOAD TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 23919570 ↗
• MalfunctionDec 25, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, DURING SET UP PRIOR TO FIRING, THE RELOAD COULD NOT BE CLOSED UNTIL THE END. THE STAPLER WOULD NOT FIRE. ANOTHER RELOAD WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891854 ↗
• MalfunctionDec 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROSTATECTOMY, THE POWERED STAPLER COULD NOT BE FIRED. THE DEVICE WAS REASSEMBLED MORE THAN TWICE, BUT THE STAPLER WAS STILL UNABLE TO FIRE. THE STAPLER AND RELOAD WERE REPLACED WITH A MANUAL STAPLER AND A NEW RELOAD TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846833 ↗
• MalfunctionNov 27, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE THORACOSCOPIC RADICAL RESECTION OF LEFT UPPER LUNG CANCER, WHEN SEVERING PULMONARY ARTERIES AND VEINS, THE STAPLER DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. THE HANDLE AND RELOAD HAD BEEN REPLACED WITH NEW ONES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669190 ↗
• MalfunctionNov 17, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A THORACOSCOPIC SEGMENTECTOMY, WHILE DETACHING BLOOD VESSELS, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23576109 ↗
• MalfunctionNov 17, 2025Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A THORACOSCOPIC RADICAL RESECTION OF LEFT UPPER LUNG CANCER, AFTER ATTACHING THE RELOAD TO THE STAPLER, THE RELOAD COULD NOT BE DEPLOY AND TISSUE COULD NOT BE STAPLED. ANOTHER STAPLER AND DISPOSABLE RELOAD WERE REPLACED TO CONTINUE THESURGERY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 23566072 ↗

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-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-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-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-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-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-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT

…and 58 more.