Endo GIA 030456Recalls & reported problems

Summary

The FDA's MAUDE database contains 337 adverse event reports that list this exact device (DI 10884523002874), received between Jun 9, 2017 and Jul 17, 2025 — classified as 71 injuries, 266 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (150 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 337 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Entrapment of Device; Misfire; Failure to Cut; Failure to Fire; Entrapment of Device; Misfire; Failure to Cut; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY PROCEDURE, THE DEVICE GOT STUCK AND COULD NOT BE REMOVED. IT COULD NOT CUT OR STOP THE BLEEDING. A NEW PRODUCT WAS USED TO PERFORM THE CUTTING AND STAPLING OF THE WOUND.

  Patient problems: Insufficient Information

  MAUDE report 22530572 ↗
• MalfunctionJul 3, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LEFT UPPER LOBECTOMY, BLEEDING OCCURRED WHEN THE WHITE RELOAD WAS USED TO DETACH THE LEFT UPPER LOBE VEIN, AND THE THE GREEN RELOAD WAS USED TO DETACH THE INTERLOBAR FISSURE; THE STAPLES DID NOT FORM A GOOD B SHAPE, SO IT WAS FINALLY SUTURED MANUALLY UNDER LAPAROSCOPY. IT WAS ALSO NOTED THAT THE STAPLE LINE WAS INCOMPLETE CENTRALLY.

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

  MAUDE report 22393022 ↗
• MalfunctionMar 25, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A THORACIC LUNG LOBECTOMY, WHEN CLOSING AND CUTTING THE TISSUE, THE ENDO GIA HANDLE AND TWO RELOADS DID NOT FIRE. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688799 ↗
• MalfunctionMar 25, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A THORACIC LUNG LOBECTOMY, WHEN CLOSING AND CUTTING THE TISSUE, THE ENDO GIA HANDLE AND TWO RELOADS DID NOT FIRE. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688784 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A THORACOSCOPIC RIGHT LOBECTOMY WHERE THE DEVICE WAS USED TO CUT AND CLOSE THE PULMONARY TRACHEA, TWO DAYS AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, THE STAPLE LINE CLOSING THE TRACHEA BURST AND EMPYEMA APPEARED. THE PATIENT WAS IN SHOCK AND NEAR DEATH. THE PATIENT WAS BROUGHT TO A DIFFERENT HOSPITAL AND GOT OUT OF DANGER. THE PATIENT WAS UNDER OBSERVATION IN THE INTENSIVE CARE UNIT. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED FOR ONE MONTH. THE ISSUE CAUSED TISSUE DAMAGE, TISSUE LOSS, AND PERMANENT FUNCTIONAL IMPAIRMENT.

  Patient problems: Pleural Empyema; Septic Shock; Tissue Breakdown

  MAUDE report 20778685 ↗
• MalfunctionSep 4, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY, WHEN THE TWO HANDLES AND TWO RELOADS WERE ABOUT TO FIRE, THE STAPLERS DID NOT FIRE. A NEW HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141326 ↗
• MalfunctionSep 4, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY, WHEN THE TWO HANDLES AND TWO RELOADS WERE ABOUT TO FIRE, THE STAPLERS DID NOT FIRE. A NEW HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140982 ↗
• MalfunctionAug 28, 2024Entrapment of Device; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A RADICAL SURGERY FOR LUNG CANCER, DURING BRONCHIAL DETACHMENT, THERE WAS DIFFICULTY IN LOOSENING AFTER CLOSURE OCCURRED WHEN USING THE DEVICE. THE BRONCHIAL STUMP WAS LACKING A ROW OF STAPLES LOOSENING, RESULTING IN THE PATIENT TO HAVE A POOR CLOSURE OF THE BRONCHIAL STUMP. THE JAWS PARTIALLY OPENED AFTER FIRING. WATER TESTING REVEALED A SERIOUS AIR LEAKAGE AT THE STUMP; SO, A MANUAL SUTURE OF THE BRONCHIAL STUMP WAS ADOPTED FOR TREATMENT. AFTER THE TREATMENT AND WATER TEST, A SLIGHT AMOUNT OF AIR LEAKAGE AT THE STUMP WAS FOUND, AND THE SURGEON SUTURED AGAIN TO RESOLVE THE LEAKAGE.

  Patient problems: Tissue Breakdown

  MAUDE report 20092046 ↗
• MalfunctionAug 6, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SINGLE-PORT THORACOSCOPIC RIGHT LOWER LOBECTOMY PROCEDURE, AT THE TIME OF BRONCHECT OMY, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THUS, THE DEVICE DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918743 ↗
• MalfunctionJul 9, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL SURGERY FOR LUNG CANCER, WHILE DETACHING THE TRACHEA, SOME OF THE STAPLES DID NOT FORM PROPERLY. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19702281 ↗
• MalfunctionJul 9, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL SURGERY FOR LUNG CANCER, WHEN DETACHING THE LUNG PARENCHYMA, THE DEVICE FIRED, BUT THE STAPLES WERE NOT PARTIALLY FORMED AND THE DISTAL STAPLE LINE WAS INCOMPLETE. TO RESOLVE THE ISSUE, THE STAPLE LINE WAS FIXED BY MANUAL SUTURING, AND THE DEVICE WAS REPLACED WITH A NEW ONE TO COMPLETE THE SURGERY.

  Patient problems: Tissue Breakdown

  MAUDE report 19701778 ↗
• MalfunctionJul 5, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE THORACOSCOPIC RADICAL RESECTION OF LUNG CANCER, AFTER CLAMPING THE TISSUE, WHEN PREPARING TO FIRE, THE STAPLER DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. 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 19684857 ↗
• MalfunctionJul 5, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RADICAL RESECTION OF LUNG CANCER PROCEDURE, WHILE CLAMPING TISSUE AND READY TO FIRE, THE STAPLER DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19682733 ↗
• MalfunctionJun 28, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A WEDGE RESECTION OF THE LEFT UPPER LOBE OF THE LUNG, THE FIRST FIRING COMPLETED THE CUTTING AND CLOSING PROCESS WITHOUT ANY PROBLEMS. THE SECOND FIRING FAILED TO COMPLETE THE CUTTING AND CLOSING PROCESS, WHICH LED TO DAMAGE THE STAPLER HANDLE. A NEW STAPLER FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635368 ↗
• MalfunctionJun 21, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, THE FIRST FIRING FAILED TO FIRE, AND THREE RELOADS ALSO FAILED TO FIRE. 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 19589840 ↗
• MalfunctionJun 21, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, THE FIRST FIRING FAILED TO FIRE, AND THREE RELOADS ALSO FAILED TO FIRE. 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 19588437 ↗
• MalfunctionJun 21, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, THE FIRST FIRING FAILED TO FIRE, AND THREE RELOADS ALSO FAILED TO FIRE. 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 19588344 ↗
• InjuryMay 20, 2024Misfire; Failure to Form Staple; Detachment of Device or Device Component; Misfire; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC CHEST WALL RESECTION AND RECONSTRUCTION, DURING CHEST WALL TUMOR RESECTION, WITH TWO RELOADS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE BUT THERE WAS POOR STAPLE FORMATION AND INCOMPLETE STAPLE LINE. THE BLADE WAS NOT MOVING FORWARD AND STOPPED AFTER THE FIRST SQUEEZE. THE PINS WERE NOT FIXED AND THE STAPLE LINE WAS INCOMPLETE CENTRALLY. THE PROCEDURE WAS CONVERTED TO OPEN DUE TO THE ISSUE. THE PINS OF THE RELOAD FELL INTO CAVITY AND REMOVED WITH A GRASPER. THE SURGEON THEN USED AN OPEN STAPLER INSTEAD OF A LAPAROSCOPIC STAPLER. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 10 TO 15 MINUTES DUE TO THE PROCEDURE¿S CONVERSION TO OPEN.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 19356469 ↗
• MalfunctionApr 3, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE; THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED ON TWO RELOAD AND TWO HANDLES. A NEW DEVICE (HANDLE AND RELOAD) WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033729 ↗
• MalfunctionMar 21, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN ENDOSCOPY PROCEDURE, THE HANDLE AND RELOAD WERE INSPECTED BEFORE BEGINNING. HOWEVER, THE STAFF NOTED THAT THE STAPLES WERE POORLY CLOSED. TO RESOLVE THE ISSUE, THE RELOAD WAS REPLACED.

  Patient problems: Tissue Breakdown

  MAUDE report 18952631 ↗
• MalfunctionJan 19, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY LOBECTOMY, WHILE WEANING LUNG PARENCHYMA, THE SURGEON COULD PRESS THE GREEN BUTTON AND SQUEEZE THE 2 HANDLES. THE HANDLES COULD NOT BE TRIGGERED BECAUSE THERE WAS NO RESISTANCE. THE 2 HANDLES AND 2 RELOADS WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE CLAMPING MECHANISM WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545473 ↗
• MalfunctionJan 3, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SINGLE PORT SEGMENTECTOMY, DURING CUTTING AND CLOSING THE LUNG SEGMENT TISSUE, THE RELOAD BURST THE STAPLES OUT AND HAD POOR FORMATION AND THE STAPLE LINE WAS INCOMPLETE CENTRALLY. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 18440693 ↗
• MalfunctionDec 15, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, THE DEVICE COULD NOT BE FIRED. TO RESOLVE THE ISSUE, ONLY THE RELOAD WAS REPLACED WITH THE SAME TYPE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340595 ↗
• MalfunctionDec 5, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PNEUMONECTOMY PROCEDURE CONVERTED TO OPEN THAT WAS UNRELATED TO DEVICE PROBLEMS, IN RESECTION OF THE BRONCHUS, WHEN THE SURGEON PRESSED THE SAFETY BUTTON, THE GREEN LIGHT WAS FLASHING. WHEN PRESSING THE BUTTON DOWN TO FIRE, NOTHING HAPPENED; THE DEVICE DID NOT FIRE. ALTHOUGH THE SCREEN SHOWED THE NEEDLE BETWEEN TWO AND THREE, THE RELOAD WAS OPENED AND REPLACED BY ANOTHER TYPE OF RELOAD THAT WORKS PROPERLY CONNECTED TO THE SAME POWERED DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267309 ↗
• MalfunctionOct 10, 2023Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL LUNG RESECTION, DURING THE THIRD FIRING USING THE FIRST HANDLE WITH THE THIRD RELOAD TO REMOVE THE LUNG LOBES, THERE WAS A CLICKING SOUND AND ANASTOMOSIS COULD NOT BE CONTINUED SINCE ONLY ABOUT ONE-THIRD OF THE STAPLES WERE FIRED. SOME DEPLOYED STAPLES DID NOT FORM THE PROPER B SHAPE. THE SAME ISSUE OCCURRED WITH THE SECOND HANDLE AND A DIFFERENT RELOAD DURING REMOVAL OF THE BRONCHUS. THE SURGEON USED A SCISSOR TO DETACH THE TISSUES AND SUTURED IT TO COMPLETE THE SURGERY.

  Patient problems: Failure to Anastomose

  MAUDE report 17906222 ↗

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-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-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-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-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-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-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-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

…and 58 more.