Endo GIA 030425Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 10884523002997), received between Aug 18, 2017 and Oct 17, 2025 — classified as 21 injuries, 119 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (82 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 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE SINGLE-PORT THORACOSCOPIC LEFT UPPER LOBECTOMY, WHEN TREATING THE LEFT UPPER LOBE VEIN, THE STAPLES BURST OUT AND FAILED TO FORM THE PROPER "B" SHAPE, RESULTING IN BLEEDING. ANOTHER RELOAD WAS USED FOR UPPER LOBE INTERLOBAR DE TACHMENT BUT ENCOUNTERED THE SAME ISSUE, WITH AN INCOMPLETE STAPLE LINE OBSERVED IN THE MIDDLE. MANUAL SUTURING WAS SUBSEQUENTLY PERFORMED LAPAROSCOPICALLY TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AS A RESULT.

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

  MAUDE report 23330839 ↗
• 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 22393037 ↗
• MalfunctionMay 12, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC LEFT UPPER LOBECTOMY, THE RELOAD COULD NOT BE FIRED WHEN THE UPPER LOBE VEIN WAS SEVERED, AND THE OPERATION WAS COMPLETED AFTER REPLACING THE RELOAD. WHEN THE INTERLOBAR FISSURE WAS DETACHED, USING ANOTHER RELOAD, THE STAPLES DID NOT HAVE A GOOD B-SHAPED FORMATION AND BLEEDING OCCURRED. FINALLY THE LUNG PARENCHYMA WAS SUTURED MANUALLY UNDER LAPAROSCOPY.

  Patient problems: Tissue Breakdown

  MAUDE report 22000416 ↗
• MalfunctionJan 20, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IT WAS FOUND THAT IT COULD NOT BE FIRED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21194397 ↗
• MalfunctionJan 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PANCREATICODUODENECTOMY, THE RELOAD WAS UNABLE TO FIRE WHILE BEING APPLIED TO THE GASTRODUODENAL ARTERY. THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THE ISSUE WAS RESOLVED BY REPLACING THE STAPLER WITH A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053820 ↗
• MalfunctionDec 19, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PNEUMATIC MEDIASTINOSCOPIC ESOPHAGECTOMY, THE RELOAD WAS UNABLE TO FIRE. THE DEVICE WAS BEING APPLIED DURING THE CLOSURE AND DETACHMENT OF THE ESOPHAGUS. THE PROBLEM WAS RESOLVED BY REPLACING THE RELOAD WITH A NEW ONE. THERE WERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20978742 ↗
• MalfunctionDec 9, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PNEUMATIC MEDIASTINOSCOPIC ESOPHAGECTOMY FOR ESOPHAGEAL CANCER, THE STAPLER DEVICE, IDENTIFIED THAT THE RELOAD, WAS NOT ABLE TO FIRE DURING THE CLOSURE AND DETACHMENT OF THE ESOPHAGUS. THE ISSUE WAS RESOLVED BY REPLACING THE MALFUNCTIONING DEVICE (HANDLE AND RELOAD) WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878586 ↗
• MalfunctionNov 13, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC LOBECTOMY, WHEN THE BLOOD VESSEL WAS CUT THE JAWS COULD NOT BE CLOSED AFTER INSTALLATION. AFTER MULTIPLE ATTEMPTS AND CONFIRMATION, IT STILL COULD NOT BE CLOSED. IT WAS REPLACED WITH A NEW RELOAD AND IT COULD BE USED NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675702 ↗
• MalfunctionMay 15, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE STAPLER DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324831 ↗
• MalfunctionApr 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WEDGE RESECTION PROCEDURE, ON TWO RELOADS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT THE HANDLE COULD NOT BE SQUEEZED. THE DEVICES DID NOT FIRE. TO RESOLVE THE ISSUE, ONLY THE RELOAD WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176448 ↗
• MalfunctionApr 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WEDGE RESECTION PROCEDURE, ON TWO RELOADS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT THE HANDLE COULD NOT BE SQUEEZED. THE DEVICES DID NOT FIRE. TO RESOLVE THE ISSUE, ONLY THE RELOAD WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176411 ↗
• MalfunctionApr 15, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) LOBECTOMY PROCEDURE, ON TWO RELOADS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, HOWEVER, THE HANDLE COULD NOT BE SQUEEZED. THE DEVICES DID NOT FIRE. TO RESOLVE THE ISSUE, ANOTHER HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113000 ↗
• MalfunctionApr 15, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) LOBECTOMY PROCEDURE, ON TWO RELOADS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, HOWEVER, THE HANDLE COULD NOT BE SQUEEZED. THE DEVICES DID NOT FIRE. TO RESOLVE THE ISSUE, ANOTHER HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112525 ↗
• MalfunctionFeb 20, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SIGMOID RESECTION PROCEDURE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, HOWEVER, THE HANDLE COULD NOT BE SQUEEZED. THE TWO RELOADS DID NOT FIRE. TO RESOLVE THE ISSUE, ANOTHER HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738113 ↗
• MalfunctionFeb 20, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SIGMOID RESECTION PROCEDURE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, HOWEVER, THE HANDLE COULD NOT BE SQUEEZED. THE TWO RELOADS DID NOT FIRE. TO RESOLVE THE ISSUE, ANOTHER HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738095 ↗
• MalfunctionJan 12, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC TOTAL MESORECTAL RESECTION, WHILE ON SUPERIOR RECTAL ARTERY CLOSURE AND DISCONNECTION OF BLOOD VESSELS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE STAPLER DID NOT FIRE. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504172 ↗
• MalfunctionDec 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATICODUODENECTOMY, WHILE RESECTING GASTRODUODENAL ARTERY, THE SURGEON COULD PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE, BUT THE 2 RELOADS DID NOT FIRE. THE 2 RELOADS WERE REPLACED AND SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370048 ↗
• MalfunctionDec 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATICODUODENECTOMY, WHILE RESECTING GASTRODUODENAL ARTERY, THE SURGEON COULD PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE, BUT THE 2 RELOADS DID NOT FIRE. THE 2 RELOADS WERE REPLACED AND SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370043 ↗
• MalfunctionDec 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE VIDEO ASSISTED THORACOSCOPIC LOBECTOMY, THE STAPLER WAS NOT ABLE TO FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367499 ↗
• MalfunctionOct 12, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A SINGLE PORT THORACOSCOPIC RIGHT LUNG LOBECTOMY, THE BLOOD VESSEL WAS PLANNED TO BE CLOSE, AFTER LOADING THE RELOAD, IT WAS FOUND THAT THE JAWS WERE INCOMPLETELY CLOSED AND THE RELOAD WAS NOT FIRED. A NEW RELOAD WITH THE SAME KIND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919740 ↗
• MalfunctionJun 30, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING GASTRIC VOLUME REDUCTION SURGERY, WHEN THE GASTRIC BODY WAS DETACHED, THERE WERE TWO RELOADS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT UNABLE TO SQUEEZE THE HANDLE AND STAPLER DID NOT FIRE. THE RELOADS WERE REPLACED AND SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239690 ↗
• MalfunctionJun 30, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING GASTRIC VOLUME REDUCTION SURGERY, WHEN THE GASTRIC BODY WAS DETACHED, THERE WERE TWO RELOADS AND ONE HANDLE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT UNABLE TO SQUEEZE THE HANDLE AND STAPLER DID NOT FIRE. THE HANDLE AND TWO RELOADS WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239642 ↗
• MalfunctionMay 26, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GENERAL SURGERY, AT THE TIME OF GASTROINTESTINAL ANASTOMOSIS, THE DEVICE WAS UNABLE TO FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. ANOTHER RELOAD OF THE SAME MODEL WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015286 ↗
• MalfunctionApr 11, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SEGMENTECTOMY, AFTER PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZED. ALL THREE RELOADS DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

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

  MAUDE report 16715882 ↗
• MalfunctionJan 13, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATIC DUODENECTOMY, IN THE RESECTION OF THE GASTRODUODENAL ARTERY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. HOWEVER, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163033 ↗

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-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-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-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-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-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-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-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-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-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-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• 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

…and 58 more.