Endo GIA EGIA30AVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10884523003123), received between Aug 10, 2017 and Sep 2, 2025 — classified as 2 deaths, 6 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (58 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 93 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A GASTRIC BYPASS PROCEDURE USING 5 RELOADS WITH A POWERED STAPLER, THE PATIENT EXPERIENCED EXTENDED HOSPITALIZATION FOR TWO ADDITIONAL DAYS AND BLEEDING IN STOOL BETWEEN 24 AND 48 HOURS POSTOPERATIVELY. STAPLE LINE BLEEDING WAS REPORTED. NO INTERVENTION WAS REQUIRED FOR THE STAPLE LINE BLEEDING.

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

  MAUDE report 22930443 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOPERATIVELY WHEN FIRING THE RELOADS, THE SURGEON OBSERVED EXCESSIVE BLEEDING THAN NORMAL. NO INTERVENTION WAS DONE OR REQUIRED.

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

  MAUDE report 22903376 ↗
• MalfunctionMar 7, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING THE USE OF THE DEVICE, THERE WERE FIRING ISSUES WITH THE RELOAD, AS THE RELOAD DID NOT FIRE WITH THE STAPLE, AND THE STAPLES DID NOT DEPLOY, RESULTING IN A CUT BUT NO STAPLES. THE DEVICE WAS REPLACED WITH ANOTHER RELOAD OF THE SAME SIZE AND MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546594 ↗
• MalfunctionJan 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE INVOLVING THE STAPLER, THERE WERE FIRING ISSUES WITH THE HANDLE. THE SURGEON WAS UNABLE TO SQUEEZE THE MANUAL HANDLE, ALTHOUGH THE GREEN SAFETY BUTTON WAS PRESSED SUCCESSFULLY. THE INSTRUMENT DID NOT FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW HANDLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED. STAPLE PUSHERS WERE VISIBLE AT THE 4CM CUT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085664 ↗
• MalfunctionOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER FIRING, THERE WAS STAPLE LINE BLEEDING ON THE FOUR RELOADS. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20390368 ↗
• MalfunctionOct 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A PROCEDURE, AFTER FIRING, THERE WAS STAPLE LINE BLEEDING ON THE FOUR RELOADS. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20380169 ↗
• MalfunctionSep 5, 2024Misfire; Firing Problem; Misfire; Firing Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RELOAD WAS DIFFICULT TO FIRE. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152109 ↗
• MalfunctionAug 9, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLE LINE WAS INCOMPLETE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE AND THE SURGEON RESECTED AND RE-STAPLED TO COMPLETE THE STAPLE LINE.

  Patient problems: Tissue Breakdown

  MAUDE report 19951036 ↗
• DeathJul 12, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A THORACIC PROCEDURE, THE STAPLES DID NOT FORM A B-SHAPE, ANOTHER RELOAD WAS USED TO CLOSE THE WOUND. AFTER USING SEVERAL LOADS IN A LUNG RESECTION THE PATIENT WAS CLOSED AND A DRAINAGE WAS USED, AND IMMEDIATELY THE RESERVOIR WAS FILLED WITH 1 LITER OF BLOOD SO THE PATIENT HAD TO BE OPENED AGAIN TO LOOK FOR THE LEAKAGE, IT WAS FOUND THAT THE LEAKAGE WAS FROM A VASCULAR STUMP. THE SURGICAL TEAM THEN APPLIED MORE CLIPS ON THE PATIENT AND A BLOOD TRANSFUSION WAS PERFORMED. AFTER THAT THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). DURING THE PROCEDURE THE USER HAD TO USE ANOTHER COMPANY'S CLIP APPLIERS. THE PATIENT WENT INTO CARDIAC ARREST AND DIED AT AROUND 2 AM.

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

  MAUDE report 19735881 ↗
• MalfunctionJan 2, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN HEPATECTOMY, DURING CUTTING OF THE ANATOMICAL PIECE, THE DEVICE FIRED UNTIL THE END BUT STAPLE LINE WAS INCOMPLETE DISTALLY. A SECOND RELOAD WAS FIRED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 18432599 ↗
• MalfunctionDec 13, 2023Misfire; Failure to Form Staple; Failure to Cut; Misfire; Failure to Form Staple; Failure to Cut

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC LAPAROSCOPIC PROCEDURE, THE STAPLE LINE WAS INCOMPLETE CENTRALLY AND THE THREE RELOADS FAILED TO CUT THE TISSUE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 18319958 ↗
• MalfunctionDec 13, 2023Misfire; Failure to Form Staple; Failure to Cut; Misfire; Failure to Form Staple; Failure to Cut

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC LAPAROSCOPIC PROCEDURE, THE STAPLE LINE WAS INCOMPLETE CENTRALLY AND THE THREE RELOADS FAILED TO CUT THE TISSUE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 18319955 ↗
• MalfunctionDec 13, 2023Misfire; Failure to Form Staple; Failure to Cut; Misfire; Failure to Form Staple; Failure to Cut

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC LAPAROSCOPIC PROCEDURE, THE STAPLER DID NOT CUT THE TISSUE COMPLETELY, AND FAILED TO FIRE TO THE END. THERE WAS NO PROBLEM AT THE STAPLE LINE TO THE PART WHERE THE TISSUE WAS CUT. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 18319935 ↗
• MalfunctionNov 28, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN AN OPEN NEPHRECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE, BUT THE DEVICE DID NOT FIRE. THE HANDLE DID NOT ADVANCE, AND NO STAPLES WERE DEPLOYED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221050 ↗
• MalfunctionNov 14, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SEGMENTECTOMY, WHEN DETACHING BLOOD VESSELS AND DETACHING LUNG TISSUE, STAPLER FIRED, BUT STAPLES BURST OUT FOR BOTH RELOADS. THE STAPLE LINE OF THE FIRST RELOAD WAS INCOMPLETE DISTALLY, AND SECOND RELOAD WITH INCOMPLETE STAPLE LINE CENTRALLY. THE RELOADS WERE REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 18134901 ↗
• MalfunctionSep 6, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STAPLER WAS NOT ABLE TO FIRE. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695718 ↗
• MalfunctionJan 31, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING TESTING, THE STAPLER DID NOT FIRE. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273175 ↗
• MalfunctionJan 11, 2023Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING AN OPEN THORACOTOMY PLUS LOBECTOMY DUE TO PNEUMONIA, THE DEVICE STAPLED BUT DID NOT CUT. TO RESOLVE THE ISSUE, A COLD CUT USING SCISSORS WAS MADE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137983 ↗
• MalfunctionDec 8, 2022Failure to Fire; Failure to Fire

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

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

  MAUDE report 15945957 ↗
• MalfunctionOct 24, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE STAPLING, BEFORE USING THE FOUR RELOADS ON THE PATIENT, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON OF THE TWO HANDLES BUT UNABLE TO SQUEEZE AND THE DEVICES DID NOT FIRE. A COMPETITOR INSTRUMENT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15661273 ↗
• MalfunctionOct 24, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE STAPLING, BEFORE USING THE FOUR RELOADS ON THE PATIENT, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON OF THE TWO HANDLES BUT UNABLE TO SQUEEZE AND THE DEVICES DID NOT FIRE. A COMPETITOR INSTRUMENT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658394 ↗
• MalfunctionOct 24, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE STAPLING, THE SURGEON USED FOUR RELOADS AND WAS ABLE TO PRESS THE GREEN BUTTON OF THE TWO HANDLES BUT UNABLE TO SQUEEZE AND THE DEVICES DID NOT FIRE. A COMPETITOR INSTRUMENT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658356 ↗
• MalfunctionOct 24, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE STAPLING, BEFORE USING THE FOUR RELOADS ON THE PATIENT, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON OF THE TWO HANDLES BUT UNABLE TO SQUEEZE AND THE DEVICES DID NOT FIRE. A COMPETITOR INSTRUMENT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658331 ↗
• MalfunctionMay 14, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE CARTRIDGE WAS NOT COMING OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402906 ↗
• MalfunctionMar 10, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE STAPLER DID NOT FIRE. THE SURGEON USER WAS NOT ABLE TO PRESS THE GREEN BUTTON AND WAS NOT ABLE TO SQUEEZED THE HANDLE. TO RESOLVE THE ISSUE, NEW PRODUCT WAS EXCHANGED.

  Patient problems: Insufficient Information

  MAUDE report 13726119 ↗

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-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-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-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-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-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-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-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

…and 58 more.