Endo GIA 030422Recalls & reported problems

Summary

The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 10884523002973), received between Jun 9, 2017 and Sep 19, 2025 — classified as 19 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (71 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 177 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PROCEDURE, IN LOBECTOMY, 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 DEVICE HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23102642 ↗
• MalfunctionJun 27, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC PELVIC ORGAN RESECTION SURGERY, WHEN ON RECTAL RESECTION, THE STAPLES OF THE RELOAD BURST OUT. ADDITIONALLY, THE STAPLE LINE WAS INCOMPLETE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 22348766 ↗
• MalfunctionApr 15, 2024Difficult to Open or Close; Human-Device Interface Problem; Difficult to Open or Close; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMICOLECTOMY, WHEN THE SURGEON CLOSED THE JAWS OF THE RELOAD TO INSERT INTO ABDOMINAL CAVITY, THE JAWS DID NOT OPEN FOR CLAMPING THE TISSUE. THE JAWS WERE UNABLE TO BE OPENED DESPITE OF MULTIPLE ATTEMPTS TO OPEN EXTRACORPOREAL. THE RELOAD WAS UNABLE TO UNLOAD AS JAWS OF THE RELOAD WERE CLOSED. A NEW HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19112809 ↗
• MalfunctionNov 3, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A GASTROPLASTY, PRIOR TO PATIENT USE, THE JAWS DID NOT OPEN WHEN INSERTING IT TO THE POWERED STAPLER DURING CYCLING. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

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

  MAUDE report 18065365 ↗
• MalfunctionJul 28, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC SEGMENTECTOMY PROCEDURE, WHEN THE LOBE PARENCHYMA WAS DISSOCIATED, IT WAS OBSERVED THAT THE STAPLE LINE DID NOT HAVE DISTANT STAPLES. A SECOND RELOAD WAS USED, BUT THE DEVICE DID NOT FIRE. A SECOND HANDLE WAS USED WITH THE SECOND RELOAD TO RESOLVE THE ISSUE.

  Patient problems: Laceration(s)

  MAUDE report 17419613 ↗
• MalfunctionJul 3, 2023Misfire; Mechanics Altered; Misfire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC BYPASS GASTROPLASTY, BEFORE FIRING IN THE STOMACH POUCH, AFTER THE RELOAD WAS INSERTED INTO THE ADAPTER, IT CLOSED IMMEDIATELY, THUS NOT BEING ABLE TO PERFORM THE LOAD TEST CYCLE. CHANGED THE RELOAD WITH THE SAME REFERENCE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S EVALUATION OF THE DEVICE FOUND THAT THE LOADING UNIT WAS PARTIALLY FIRED TO THE 5CM CUT LINE WITH THE INTERLOCK ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247001 ↗
• MalfunctionJun 15, 2023Unintended Movement; Unintended Movement

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BYPASS GASTROPLASTY. UPON LOADING THE RELOAD IN THE ADAPTER, THE JAWS CLOSED IMMEDIATELY, CAUSING THE DEVICE TO NOT PERFORM THE CYCLE READING. TO RESOLVE THE ISSUE, A NEW RELOAD OF THE SAME TYPE WAS USED WITH THE SAME HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139424 ↗
• MalfunctionJun 7, 2023Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTROPLASTY PROCEDURE. THE RELOAD CLOSED AS SOON AS IT WAS INSERTED INTO THE ADAPTER, WITHOUT ANY BUTTON BEING PRESSED. BUT IT DID NOT OPEN DURING THE TEST CYCLE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079886 ↗
• MalfunctionJun 5, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTROJEJUNAL ANASTOMOSIS, THE STAPLER DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. USED OTHER RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17065496 ↗
• MalfunctionJun 5, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, WHEN DETACHING THE INTERLOBAR FISSURE, THERE WAS AN INCOMPLETE STAPLE LINE DISTALLY. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17058235 ↗
• MalfunctionMay 25, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY BYPASS, ON TWO RELOADS, AT THE TIME OF RELOAD INSERTION ONTO THE STAPLER AND BEFORE INSERTING INTO CAVITY, THE RELOADS CLOSED AND NO LONGER OPENED. TO RESOLVE THE ISSUE, A NEW RELOAD OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005185 ↗
• MalfunctionMay 25, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY BYPASS, ON TWO RELOADS, AT THE TIME OF RELOAD INSERTION ONTO THE STAPLER AND BEFORE INSERTING INTO CAVITY, THE RELOADS CLOSED AND NO LONGER OPENED. TO RESOLVE THE ISSUE, A NEW RELOAD OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005004 ↗
• MalfunctionMay 15, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY SLEEVE PROCEDURE, WHEN THE RELOAD WAS INSERTED INTO THE STEM, THE JAWS WERE ABLE TO CLOSE, BUT IT DID NOT OPEN WITHOUT ANY TRIGGER WHEN THE CYCLE TEST WAS PERFORMED. A NEW RELOAD OF THE SAME PRODUCT WAS USED WITH THE SAME HANDLE, SHELL AND ADAPTER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931098 ↗
• MalfunctionMay 12, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY PROCEDURE, THE USER WAS ABLE TO PRESS THE GREEN BUTTON. HOWEVER, THE HANDLE COULD NOT BE SQUEEZED. THE DEVICE 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 16924341 ↗
• MalfunctionMay 5, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE DID NOT FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876878 ↗
• MalfunctionMar 21, 2023Failure to Read Input Signal; Device Displays Incorrect Message; Failure to Read Input Signal; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A GASTROPLASTY BYPASS PROCEDURE, THE RELOAD HAD AN ERROR, THE SCREEN INITIALLY INDICATED AN EXCESSIVE LOAD ERROR. AFTERWARDS IT SHOWED AN ERROR INDICATING THE RELOAD WAS NOT RECOGNIZED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588124 ↗
• MalfunctionMar 6, 2023Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY, ON RESECTION OF THE APPENDIX, THE DID NOT RELEASE ANY STAPLES. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THE JAWS DID NOT OPEN. IT WAS OPENED AND WAS RELEASED FROM THE TISSUES THEN THE STAPLER WAS REMOVED FROM THE ABDOMINAL CAVITY. MANUAL REPAIR WAS PERFORMED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491720 ↗
• MalfunctionMar 2, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BYPASS GASTROPLASTY, WHEN EXCHANGING THE LOAD TO CONTINUE WITH THE PROCEDURE, THE JAWS OF THE RELOAD DID NOT OPEN. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16471330 ↗
• MalfunctionFeb 23, 2023Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BYPASS GASTROPLASTY, WHEN RELOAD WAS ATTACHED TO PERFORM THE LOAD TEST, THE RELOAD DID NOT OPEN. THE DOCTOR ALSO REINSERTED THE LOAD WITH SAME RESULTS. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. PLI 10 MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE LOADING UNIT WAS PARTIALLY FIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427475 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (RYGB) PROCEDURE, IN THE STOMACH POUCH, JEJUNUM DISSECTION, JEJUNOJENUNAL (JJ) AND GASTROJEJUNAL (GJ) ANASTOMOSES, THERE WAS A BLOOD LEAK OF FIVE HUNDRED CUBIC CENTIMETER (500CC) OR MORE. THIS RESULTED IN BLOOD TRANSFUSION. ADDITIONALLY, THE PATIENT HAD A EXTENDED HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16019142 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DAY AFTER THE CREATION OF STOMACH POUCH IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE PATIENT HAD POST-OPERATIVE BLOOD LEAK.  THERE BLOOD LOSS OF 500CC OR MORE WHICH RESULTED TO BLOOD TRANSFUSION. THE PATIENT HOSPITALIZATION WAS EXTENDED FOR 3 DAYS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16017045 ↗
• MalfunctionNov 30, 2022Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BYPASS GASTROPLASTY, BEFORE PLACING THE STAPLER IN THE CAVITY, AFTER INSERTING THE RELOAD INTO THE STAPLER AND PERFORMING THE CYCLE TEST, THE JAWS WOULD NOT OPEN. TO RESOLVE THE ISSUE, A NEW HANDLE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885588 ↗
• MalfunctionOct 7, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC GASTROPLASTY BYPASS, AT THE START OF STAPLING WHEN INSERTING THE LOAD INTO THE STAPLER, THE LOAD WOULD NOT OPEN AFTER DEVICE READ SIGN. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15565451 ↗
• MalfunctionSep 24, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, ON A SINGLE-PORT THORACOSCOPE, AFTER LOADING THE DEVICE, BEFORE TOUCHING TISSUE, THE STAPLER COULD NOT BE FULLY CLOSED. THE GAP BETWEEN THE ANVIL AND THE RELOAD WAS VERY OBVIOUS. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480443 ↗
• MalfunctionJul 29, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC BARIATRIC BYPASS PROCEDURE, WHEN CHANGING THE RELOAD WHICH COULD NOT TO BE OPENED UNTIL A MANUAL RETRACTION TOOL WAS USED, THERE WAS A FALSE RELOAD READING. THERE WAS A DETECTED RELOAD WITHOUT THE RELOAD BEING CONNECTED. A MANUAL STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131653 ↗

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-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-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-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-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-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-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-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT

…and 58 more.