Endo GIA EGIA60CTAVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884523003239), received between Oct 9, 2017 and Jan 8, 2026 — classified as 1 injury, 47 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (18 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Retraction Problem; Noise, Audible

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE RELOAD MADE A STRANGE NOISE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE AND LOADING A NEW ADDITIONAL RELOAD. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE I-BEAM WAS SLIGHTLY ADVANCED.

  Patient problems: Insufficient Information

  MAUDE report 24015186 ↗
• MalfunctionOct 21, 2025Break; Failure to Form Staple; Break; Failure to Form Staple

  IT WAS REPORTED THAT DURING A HEPATECTOMY, THE SHIPPING WEDGE BECAME STUCK IN THE MIDDLE AND FOLLOWED BY THE I-BEAM AUTO RETURN WHICH CAUSE STAPLE FORMATION ISSUE. THE DEVICE WAS REPLACED WITH ANOTHER RELOAD.

  Patient problems: Tissue Breakdown

  MAUDE report 23354304 ↗
• MalfunctionAug 27, 2025Break; Misfire; Mechanics Altered; Break; Misfire; Mechanics Altered

  IT WAS REPORTED THAT THE RELOAD HAD AN UNKNOWN ISSUE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE RELOAD WAS PARTIALLY FIRED AND DEFORMED CLAMPING MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906088 ↗
• MalfunctionAug 7, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO USE, THE JAWS OF THE TWO RELOADS DID NOT CLOSE COMPLETELY. THE DEVICE WAS REPLACED WITH A NEW PRODUCT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738783 ↗
• MalfunctionAug 7, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO USE, THE JAWS OF THE TWO RELOADS DID NOT CLOSE COMPLETELY. THE DEVICE WAS REPLACED WITH A NEW PRODUCT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737742 ↗
• MalfunctionMar 25, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PRIOR TO USE, DURING THE SETUP PHASE BEFORE FIRING, THE DEVICE HAD UNCONTROLLED ARTICULATION. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691602 ↗
• MalfunctionNov 27, 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 PROCEDURE, THE STAPLE LINE FROM THE THREE RELOADS WAS INCOMPLETE, AND THERE WAS BLEEDING. THE ISSUE WAS RESOLVED BY USING A NEW RELOAD. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

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

  MAUDE report 20802791 ↗
• MalfunctionNov 27, 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 PROCEDURE, THE STAPLE LINE FROM THE THREE RELOADS WAS INCOMPLETE, AND THERE WAS BLEEDING. THE ISSUE WAS RESOLVED BY USING A NEW RELOAD. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

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

  MAUDE report 20802571 ↗
• MalfunctionNov 27, 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 PROCEDURE, THE STAPLE LINE FROM THE THREE RELOADS WAS INCOMPLETE, AND THERE WAS BLEEDING. THE ISSUE WAS RESOLVED BY USING A NEW RELOAD. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

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

  MAUDE report 20802377 ↗
• MalfunctionNov 7, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SURGEON TOOK THE TISSUE, THE STAPLER BROKE. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 20632094 ↗
• MalfunctionFeb 13, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, THE BLADE DID NOT ADVANCE AND NO STAPLES WERE DEPLOYED OR FIRED FOR THE TWO RELOADS. TO RESOLVE THE ISSUE, ANOTHER RELOAD WAS USED WITH THE SAME HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18700463 ↗
• MalfunctionFeb 6, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE STAPLER DID NOT FIRE. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE PATIENT HAD INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18653144 ↗
• MalfunctionDec 28, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE TWO RELOAD SEAMS WERE NOT ADVANCING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414675 ↗
• MalfunctionDec 28, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE TWO RELOAD SEAMS WERE NOT ADVANCING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18413342 ↗
• MalfunctionOct 12, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE STAPLER DID NOT STICK; DID NOT CLOSE/CLAMP WELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928034 ↗
• MalfunctionFeb 6, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE STAPLER COULD NOT BE CLOSED UNTIL END.

  Patient problems: Insufficient Information

  MAUDE report 16307401 ↗
• MalfunctionOct 31, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA, THE DEVICE DID NOT FIRE FOR PRE-FIRING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 15704833 ↗
• MalfunctionOct 31, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA, THE DEVICE DID NOT FIRE FOR PRE-FIRING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 15704535 ↗
• MalfunctionApr 29, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE JAW OF THE RELOAD WAS NOT OPENED. TO RESOLVE THE ISSUE, ANOTHER RELOAD WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 14255130 ↗
• MalfunctionNov 29, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, THE DEVICE WAS UNABLE TO FIRE - GREEN BUTTON COULD NOT BE PRESSED. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12881998 ↗
• MalfunctionJul 21, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC BARIATRIC SURGERY, THE RELOAD WAS INSERTED INTO THE STAPLER AND IT DID NOT FIRE, THE NUMBER 0 APPEARED ON THE STAPLER DISPLAY. IN ORDER TO FIX THE ISSUE, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207911 ↗
• MalfunctionJun 21, 2021Entrapment of Device; Failure to Form Staple; Detachment of Device or Device Component; Entrapment of Device; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NEPHRECTOMY WHILE APPLYING ON RENAL PEDICLE THE DEVICE WOULD FIRE BUT THE STAPLE LINE WAS INCOMPLETE PROXIMALLY AND THE JAWS OF THE DEVICE LOCKED ON TISSUE. ALSO, THE SQUARE PIECE OF TITANIUM AT THE TOP OF THE RELOAD WHICH SHOWS THE KNIFE BLADE FELL OFF INTO THE PATIENT CAVITY. IN ORDER TO FIX THE ISSUE, A NEW SET OF HANDLE AND RELOAD WAS THEN OPENED AND USED. THE COMPONENT OF THE DEVICE WAS RETRIEVED USING A GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037882 ↗
• MalfunctionMay 7, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE SURGEON WAS NOT ABLE TO PRESS THE GREEN BUTTON AND WAS NOT ABLE TO SQUEEZE THE HANDLE. DEVICE WAS NOT ABLE TO FIRE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11792609 ↗
• MalfunctionMay 5, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE WAS UNABLE TO FIRE. GREEN BUTTON WAS NOT PRESSED AND HANDLE COULD NOT BE SQUEEZED.

  Patient problems: Insufficient Information

  MAUDE report 11781481 ↗
• MalfunctionMar 10, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE BUT THE DEVICE DID NOT FIRE. THE STAPLES DID NOT COME OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453728 ↗

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-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-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-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-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-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-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-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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT

…and 58 more.