Endo GIA 030454Recalls & reported problems

Summary

The FDA's MAUDE database contains 252 adverse event reports that list this exact device (DI 10884523002850), received between Aug 3, 2017 and Jul 1, 2025 — classified as 5 deaths, 62 injuries, 185 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (102 reports).

1 FDA recall record name this device's identifier.

72 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 26, 2018Terminated

   Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

   Z-1817-2018 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 252 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE ON TISSUE RESECTION, THE DOCTOR FOUND THAT TWO CONSECUTIVE STAPLER RELOADS FELL OFF AND BROKE, WHICH SERIOUSLY AFFECTED THE PROGRESS OF THE OPERATION. THE SUBSEQUENT DOCTOR COULD ONLY SUTURE MANUALLY WITH SUTURES, AND THE OPERATION WENT SMOOTHLY.

  Patient problems: Insufficient Information

  MAUDE report 22371523 ↗
• MalfunctionJul 1, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE ON TISSUE RESECTION, THE DOCTOR FOUND THAT TWO CONSECUTIVE STAPLER RELOADS FELL OFF AND BROKE, WHICH SERIOUSLY AFFECTED THE PROGRESS OF THE OPERATION. THE SUBSEQUENT DOCTOR COULD ONLY SUTURE MANUALLY WITH SUTURES, AND THE OPERATION WENT SMOOTHLY.

  Patient problems: Insufficient Information

  MAUDE report 22371519 ↗
• MalfunctionJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY INVOLVING ONE RELOAD, THERE WAS BLEEDING IN THE RENAL ARTERY AND STAPLE LINE BLEEDING AFTER FIRING THE RELOAD. THE STAPLE LINE REQUIRED REPLACEMENT WITH SUTURING TO CONTROL THE BLEEDING. THESE ISSUES RESULTEDIN EXTENDED SURGICAL TIME FOR 30 MINUTES. SUTURING WAS PERFORMED BOTH TO CONTROL THE BLEEDING AND AS A REPLACEMENT FOR THE STAPLE LINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22349843 ↗
• MalfunctionJun 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE STAPLER EXPERIENCED FIRING ISSUES WITH THE RELOAD COMPONENT. THE STAPLER CARTRIDGE WAS INSERTED INTO THE SHOOTER BUT DID NOT PUNCH OR CUT WHILE IN USE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW CARTRIDGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201482 ↗
• MalfunctionApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROUX-EN-Y GASTRIC BYPASS, THERE WAS A STAPLE LINE LEAKAGE AT THE OPENING AT THE END OF A SIDE-TO-SIDE ANASTOMOSIS AFTER A LEAK TEST WAS PERFORMED. THERE WAS NO TENSION AND NO COMPLICATION. THE SURGEON PERFORMED A MANUAL SUTURING AS A STAPLE LINE REINFORCEMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 21774092 ↗
• MalfunctionMar 25, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO THORACOSCOPIC LOBECTOMY, THE STAPLER SUTURED ON THE FIRST RELOAD, BUT DID NOT STAPLE DURING THE NEXT RELOAD. THE USER REPLACED THE RELOAD; THE SAME THING HAPPENED. A STAPLER AND RELOAD FROM ANOTHER COMPANY WERE USED, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686088 ↗
• MalfunctionMar 25, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO THORACOSCOPIC LOBECTOMY, THE STAPLER SUTURED ON THE FIRST RELOAD, BUT DID NOT STAPLE DURING THE NEXT RELOAD. THE USER REPLACED THE RELOAD; THE SAME THING HAPPENED. A STAPLER AND RELOAD FROM ANOTHER COMPANY WERE USED, AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686051 ↗
• MalfunctionFeb 6, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WERE ISSUES AFTER FIRING; THERE WAS A STAPLE FORMATION; IT WAS NOT HOLDING AND FORMED WELL. THE END OF THE STAPLE LINE WAS NOT COMPLETED. THE RELOAD COMPONENT WAS USED WITH A MANUAL HANDLE. TO RESOLVE THE ISSUE, A NEW LOADING UNIT WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 21324224 ↗
• MalfunctionJan 6, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC LEFT HEPATECTOMY, WHEN CUTTING OFF THE LEFT HEPATIC PEDICLE, THERE WAS POOR STAPLE FORMATION. THE STAPLES PARTLY FORMED. REINFORCEMENT WITH SUTURE WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 21081898 ↗
• MalfunctionSep 13, 2024Misfire; Failure to Form Staple; Firing Problem; Misfire; Failure to Form Staple; Firing Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE FIRST RELOAD WAS FIRED FOR A HALF AND NEAR THE LAST 15MM. WITH NO PROPER STAPLE LINE FORMATION. IT WAS MENTIONED THAT THE JAW OF THE SECOND RELOAD GOT STUCK AND WAS UNABLE TO OPEN IN THE MIDDLE OF THE FIRING. THE JAW OF THE SECOND RELOAD HAD TO BE OPEN USING ANOTHER HAND INSTRUMENTS. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20213355 ↗
• MalfunctionAug 27, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE PHYSICIAN TRIED TO FIRE THE RELOADS, BUT IT COULD NOT BE FIRED. 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 20076403 ↗
• MalfunctionAug 27, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE PHYSICIAN TRIED TO FIRE THE RELOADS, BUT IT COULD NOT BE FIRED. 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 20076087 ↗
• MalfunctionApr 22, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IN CLOSING THE TISSUE, THERE WAS POOR STAPLE FORMATION. TO RESOLVE THE ISSUE, ANOTHER RELOAD WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 19153175 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A SUB-COSTAL HEPATECTOMY, THERE WAS NO ISSUE WHEN 30 AND 45 MILLIMETER WHITE RELOADS WERE USED. HOWEVER, FIVE HOURS LATER, THE PATIENT WAS TAKEN BACK TO THE EMERGENCY ROOM DUE TO BLEEDING. THE STAPLE LINE OF BOTH RELOADS WERE OPEN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18988190 ↗
• MalfunctionMar 11, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HEPATECTOMY, WHILE STAPLING ON TISSUE, THE STAPLER WAS NOT ABLE TO FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. THE ISSUE OCCURRED ON TWO MORE RELOADS. A NEW RELOAD WAS THEN USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882661 ↗
• MalfunctionDec 29, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LEFT UPPER LOBECTOMY, THE CUTTING STAPLER WAS BLOCKED, RESULTING IN A FAILURE TO FIRE NORMALLY. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422562 ↗
• MalfunctionNov 7, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A HEMIHEPATECTOMY, IN CLOSING THE TISSUE INTO THE ABDOMINAL CAVITY, THE FRONT END OF THE RELOAD WAS INCOMPLETELY CLOSED. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED WITH THE SAME HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089361 ↗
• MalfunctionNov 6, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY PROCEDURE, AT THE TIME OF LIVER HEPATIC VEIN TRANSECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THEREFORE, THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED IN THREE HANDLES AND FIVE RELOADS. A NEW RELOAD AND HANDLE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077742 ↗
• MalfunctionNov 6, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY PROCEDURE, AT THE TIME OF LIVER HEPATIC VEIN TRANSECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THEREFORE, THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED IN THREE HANDLES AND FIVE RELOADS. A NEW RELOAD AND HANDLE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077616 ↗
• MalfunctionNov 6, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY PROCEDURE, AT THE TIME OF LIVER HEPATIC VEIN TRANSECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THEREFORE, THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED IN THREE HANDLES AND FIVE RELOADS. A NEW RELOAD AND HANDLE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077422 ↗
• MalfunctionNov 6, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY PROCEDURE, AT THE TIME OF LIVER HEPATIC VEIN TRANSECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THEREFORE, THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED IN THREE HANDLES AND FIVE RELOADS. A NEW RELOAD AND HANDLE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077289 ↗
• MalfunctionNov 2, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY PROCEDURE, AT THE TIME OF LIVER HEPATIC VEIN TRANSECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THEREFORE, THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED IN THREE HANDLES AND FIVE RELOADS. 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 18059283 ↗
• MalfunctionNov 2, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY PROCEDURE, AT THE TIME OF LIVER HEPATIC VEIN TRANSECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THEREFORE, THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED IN THREE HANDLES AND FIVE RELOADS. 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 18059198 ↗
• MalfunctionNov 2, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY PROCEDURE, AT THE TIME OF LIVER HEPATIC VEIN TRANSECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THEREFORE, THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED IN THREE HANDLES AND FIVE RELOADS. 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 18059072 ↗
• MalfunctionNov 2, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY PROCEDURE, AT THE TIME OF LIVER HEPATIC VEIN TRANSECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THEREFORE, THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED IN THREE HANDLES AND FIVE RELOADS. 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 18058981 ↗

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 tr
• 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-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-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-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-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-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

…and 57 more.