Endo GIA 030414Recalls & reported problems

Summary

The FDA's MAUDE database contains 648 adverse event reports that list this exact device (DI 10884523002928), received between Jul 31, 2017 and Oct 17, 2025 — classified as 1 death, 83 injuries, 564 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (301 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 648 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 23330864 ↗
• DeathSep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THREE DAYS POST-OPERATIVELY, THE ANASTOMOTIC STAPLE LINE LEAKED. A LEAK TEST PERFORMED RETURNED POSITIVE. THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT DIED EIGHT DAYS AFTER THE INITIAL SURGERY.

  Patient problems: Failure to Anastomose; Insufficient Information

  MAUDE report 23006583 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, THE STAPLE LINE LEAKED. THE PATIENT EXPERIENCED EXTENDED HOSPITALIZATION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT.

  Patient problems: Tissue Breakdown

  MAUDE report 23000918 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, STAPLE LINE LEAKS OCCURRED. THE PATIENT REQUIRED ADMISSION TO THE INTENSIVE CARE UNIT AND EXPERIENCED AN EXTENDED HOSPITALIZATION.

  Patient problems: Tissue Breakdown

  MAUDE report 22976936 ↗
• MalfunctionJul 25, 2025Difficult or Delayed Positioning; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE RELOAD WAS USED AND DID NOT SEAL PROPERLY, LACK GOOD COMPRESSION AND LEAK. ADDITIONALLY, THE RELOAD DOES NOT ROTATE WHEN MOUNTED IN THE STAPLER.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 22616569 ↗
• MalfunctionJul 17, 2025Difficult or Delayed Positioning; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRECTOMY, GRASPING WITH THE TWO RELOADS WERE DIFFICULT. THE RELOADS ALSO DID NOT ROTATE WHEN MOUNTED ON THE HANDLE. THE STAPLE LINE OF THE TWO RELOADS WERE BLEEDING. THE STAPLE LINES ALSO DID NOT HOLD AND LEAKED. A LEAK TEST CAME OUT POSITIVE.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 22535435 ↗
• MalfunctionJul 17, 2025Difficult or Delayed Positioning; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRECTOMY, GRASPING WITH THE TWO RELOADS WERE DIFFICULT. THE RELOADS ALSO DID NOT ROTATE WHEN MOUNTED ON THE HANDLE. THE STAPLE LINE OF THE TWO RELOADS WERE BLEEDING. THE STAPLE LINES ALSO DID NOT HOLD AND LEAKED. A LEAK TEST CAME OUT POSITIVE.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 22535314 ↗
• MalfunctionJul 17, 2025Difficult or Delayed Positioning; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRECTOMY, GRASPING WITH THE TWO RELOADS WERE DIFFICULT. THE RELOADS ALSO DID NOT ROTATE WHEN MOUNTED ON THE HANDLE. THE RELOADS DID NOT SEAL PROPERLY. THE RELOADS LACKED COMPRESSION AND LEAKED.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 22535236 ↗
• MalfunctionJul 17, 2025Difficult or Delayed Positioning; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRECTOMY, TWO RELOADS DID NOT SEAL PROPERLY. THE RELOADS LACKED COMPRESSION AND LEAKED. GRASPING WITH THE STAPLER WAS DIFFICULT AND THE RELOADS ALSO DID NOT ROTATE WHEN MOUNTED ON THE HANDLE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 22535001 ↗
• MalfunctionJan 8, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION OF RECTAL CANCER, DURING CLOSURE AND DIVISION OF THE RECTUM, THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON AND THE HANDLE COULD NOT BE SQUEEZED. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THEISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103051 ↗
• MalfunctionNov 20, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LEFT UPPER LOBE PROCEDURE, WHEN THE MANUAL HANDLE AND RELOAD WERE USED TO CLOSE AND DETACH THE INCOMPLETELY SPLIT INTERLOBULAR FISSURE, A CLICKING SOUND WAS HEARD, THE HANDLE DID NOT RESPOND WHEN PRESSED, AND THE STAPLES IN THE RELOAD BURST OUT. 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 20735598 ↗
• MalfunctionOct 25, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, DURING CLAMPING OF THE TISSUE, AFTER PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZED, AND THE DEVICE DID NOT FIRE. A NEW RELOAD WITH THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536268 ↗
• MalfunctionOct 14, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PARTIAL GASTRECTOMY, WHEN THE TISSUE WAS CLAMPED AND THE SAFETY WAS DEPLOYED DURING PREPARATION TO FIRE, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER KIND RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439619 ↗
• MalfunctionOct 11, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, WHEN USING THE HANDLE AND RELOAD TO DETACH THE RIGHT HEMICOLE, THE RELOAD COULD NOT BE CLOSED AFTER STAPLING. IT WAS NOTED THAT THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THE USER REPLACED THE HANDLE AND RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428025 ↗
• MalfunctionOct 1, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACIC SURGERY (VATS) LOBECTOMY PROCEDURE, THE STAPLER DID NOT FIRE EVEN AFTER EXTRA RELOAD WAS USED. 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 20347760 ↗
• MalfunctionSep 20, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER FIRING, IT WAS OBSERVED THAT THE STAPLE LINE WAS PROXIMALLY INCOMPLETE. THE ISSUE OCCURRED IN TWO RELOADS. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20267112 ↗
• MalfunctionSep 20, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, THE STAPLE LINE WAS INCOMPLETE ON THE PROXIMAL SIDE FOR ALL FOUR RELOADS. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20267042 ↗
• MalfunctionSep 20, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, THE STAPLE LINE WAS INCOMPLETE ON THE PROXIMAL SIDE FOR ALL FOUR RELOADS. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20267009 ↗
• MalfunctionSep 19, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLE LINE WAS INCOMPLETE PROXIMALLY. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20260179 ↗
• MalfunctionSep 17, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON FOUR RELOADS, THE STAPLE LINE WAS PROXIMALLY INCOMPLETE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20241773 ↗
• MalfunctionAug 23, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE THE DEVICE RELOAD MISFIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049054 ↗
• MalfunctionAug 8, 2024Misfire; Failure to Form Staple; Failure to Cut; Firing Problem; Misfire; Failure to Form Staple; Failure to Cut; Firing Problem

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC BULLECTOMY, WHEN DETACHING THE LUNG LOBE TISSUE, THE STAPLES BURST OUT, THE DEVICE PARTIALLY FIRED, AND THE STAPLER PARTIALLY CUT THE TISSUE. IT WAS ALSO NOTED THAT THE STAPLE COULD NOT BE FORMED WHEN DETACHING LUNG TISSUE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19942779 ↗
• MalfunctionJul 25, 2024Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR RELOADS EXPERIENCED ISSUES WHERE THERE WERE PARTIAL CUTS BUT COMPLETE STAPLE LINE PROBLEMS AFTER FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832458 ↗
• MalfunctionJul 25, 2024Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR RELOADS EXPERIENCED ISSUES WHERE THERE WERE PARTIAL CUTS BUT COMPLETE STAPLE LINE PROBLEMS AFTER FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832364 ↗
• MalfunctionJul 25, 2024Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR RELOADS EXPERIENCED ISSUES WHERE THERE WERE PARTIAL CUTS BUT COMPLETE STAPLE LINE PROBLEMS AFTER FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832009 ↗

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 tr
• 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-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-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-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-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-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-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-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
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT

…and 58 more.