Endo GIA EGIA30AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884523003062), received between Apr 5, 2017 and Feb 23, 2026 — classified as 3 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (28 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE STAPLER COULD NOT BE CLOSED UNTIL THE END. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416286 ↗
• MalfunctionFeb 18, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A DETACHMENT OF CECAL, MESO-APPENDAGE, THE DISTAL STAPLES WERE OPEN WITHOUT FORMING FROM THE SIDE PROXIMAL TO THE COLON. CLIPS WERE USED TO SECURE THE TISSUE DUE TO THE INCOMPLETE STAPLE LINE. THE BASE WAS SUTURED AND A SECOND PURPLE RELOAD WAS PLACED. THEY DRY OUT THE OPEN STAPLES IN THE COLON AND ADHERE TO ANOTHER TWO HANDLES OF THE THIN INTESTINE.

  Patient problems: Tissue Breakdown

  MAUDE report 24380920 ↗
• MalfunctionOct 9, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS DIFFICULTY CLOSING THE JAWS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409845 ↗
• MalfunctionJan 9, 2024Misfire; Mechanics Altered; Misfire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THERE WAS AN UNKNOWN DEVICE ISSUE. THE RELOAD WAS REPLACED AND USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT A VISUAL INSPECTION OF INTERNAL COMPONENTS REVEALED THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481011 ↗
• MalfunctionDec 28, 2023Entrapment of Device; Failure to Form Staple; Entrapment of Device; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY, DURING GASTRO-ENTERO ANASTOMOSIS, THE STAPLER WORKED NORMALLY. HOWEVER, THE CLAMP WAS STUCK, AND THE STAPLER DID NOT STOP. IT DID NOT RECOGNIZE THE FOUCHET PROBE AND STAPLED IT WITH THE TISSUE. THERE WAS A POOR STAPLE FORMATION ON THE FOUCHET PROBE AND THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES SINCE IT WAS NECESSARY TO REMOVE THE FOUCHET PROBE THAT WAS STUCK IN THE STAPLE LINE AND REDO THE ANASTOMOSIS. THE PROCEDURE WAS COMPLETED WITH THE SAME STAPLER. THE PATIENT WAS DISCHARGED.

  Patient problems: Tissue Breakdown

  MAUDE report 18415605 ↗
• MalfunctionAug 18, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE STAPLER COULD NOT BE CLOSED UNTIL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569719 ↗
• MalfunctionAug 8, 2023Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC APPENDECTOMY, WHILE IN THE APPENDIX, THE JAWS OF THE DEVICE LOCKED ON TISSUE. THE JAWS WOULD NOT OPEN. A NEW POWER STAPLER WAS OPENED AND A NEW TROCAR HAD TO BE ADDED TO PASS THE NEW STAPLER TO RELEASE THE TISSUE. THE INCISION HAD TO BE EXTENDED TO REDO THE PASSAGE FOR THE NEW 12MM TROCAR. THE SURGEON STAPLED A LITTLE FURTHER DOWN TO RELEASE THE TISSUE AND THE RELOAD.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 17483555 ↗
• MalfunctionJul 25, 2023Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHILE FIRING, THE DEVICE DID NOT FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. IT WAS OBSERVED THAT THE RELOAD WAS PREFIRED. THE SAME HANDLE AND NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390432 ↗
• MalfunctionFeb 23, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A GASTRIC SLEEVE PROCEDURE, 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 16431797 ↗
• InjuryNov 10, 2022Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTROPLASTY BY VIDEO, BOTH RELOAD OPENED THE TISSUE AT THE TIME OF OPENING AND UNLOADING THE RELOADS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15774298 ↗
• InjuryMay 23, 2022Entrapment of Device; Misfire; Failure to Form Staple; Entrapment of Device; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER. DURING LAPAROSCOPIC SURGERY FOR OBESITY, THE JAWS ALSO LOCKED ON TISSUE. FIRING CYCLE WAS NOT COMPLETED SO STAPLE LINE WAS INCOMPLETE. TISSUE WAS CUT NEAR THE SITE WHERE JAWS WERE LOCKED. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14471056 ↗
• MalfunctionApr 7, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BOTH RELOAD DID NOT FIRE AFTER THE SURGEON GRABBED A THICK TISSUE.

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

  MAUDE report 14048802 ↗
• MalfunctionMar 8, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, TWO HANDLES AND A RELOAD DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 13694343 ↗
• MalfunctionJul 6, 2021Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND COULD S QUEEZE THE HANDLE, BUT THE STAPLER COULD NOT BE FIRED DURING THE TRANSECTION OF LUNG TISSUE. IT CAN BE OBSERVED ON THE RELOAD THAT SOME STAPLES CAME OUT BUT WERE NOT FORMED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120641 ↗
• MalfunctionJan 15, 2021Misfire

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOT FIRED NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11176966 ↗
• MalfunctionJun 11, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC SLEEVE, AFTER THE RELOAD WAS LOADED ON THE HANDLE, SURGEON COULD NOT CLOSE THE JAW. RELOAD WAS UNLOADED AND ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142137 ↗
• MalfunctionApr 13, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING VIDEO ASSISTED THORACOSCOPIC SURGERY LOBECTOMY AT BRONCHUS AND PULMONARY ARTERY, TWO RELOADS DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9952284 ↗
• MalfunctionMar 30, 2020Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING TRANSECTION OF MASS ON A LAPAROSCOPIC WEDGE RESECTION, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE STAPLER COULD NOT BE FIRED BECAUSE IT WAS PRE-FIRED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9896386 ↗
• MalfunctionDec 17, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING VIDEO ASSISTED THORACOSCOPIC LOBECTOMY PROCEDURE, WHILE TRANSACTION OF LOBAR BRONCHUS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE. THE DEVICE WAS NOT ABLE TO FIRE. THE SURGEON CHANGED TO ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9480428 ↗
• MalfunctionSep 23, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A BARIATRIC SLEEVE GASTRECTOMY LAPAROSCOPIC PROCEDURE, THE RELOAD DID NOT FIRE. THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9107796 ↗
• MalfunctionAug 19, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ON DISSECTION OF THE GREATER OMENTUM OF THE STOMACH, THE STAPLER WAS ABLE TO FIRE, THE NURSE FOUND OUT A PIECE OF PURPLE COMPONENT BROKE OFF AND WAS STUCK AT THE BOTTOM PART OF THE JAW. THEY USED SIX RELOADS BUT ONLY FOUND THE PURPLE PIECE IN THE DEVICE. THEY CHECKED TO SEE IF ANY COMPONENT FELL INTO THE CAVITY AND FOUND THAT NOTHING FELL TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8906741 ↗
• MalfunctionJul 24, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE TRANSECTION OF LUNG PARENCHYMA ON A LAPAROSCOPY VIDEO ASSISTED THORACOSCOPIC LOBECTOMY, THE STAPLER DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8821689 ↗
• MalfunctionJun 26, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATO-PANCREATO-BILIARY (HPB), THE DEVICE WOULD NOT FIRE. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737499 ↗
• MalfunctionJun 12, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRECTOMY, ON STAPLER REMOVAL, THREE RELOADS CANNOT BE ARTICULATED BACK TO ITS ORIGINAL POSITION AFTER ARTICULATION SO THE STAPLER WAS NOT ABLE TO REMOVE DIRECTLY FROM THE TROCAR. TO RESOLVE THE ISSUE, TOOK THE STAPLER OUT WITH THE TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8693013 ↗
• MalfunctionApr 11, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR THE THORACO/ESOPHAGUS, AT THE FIRST FIRING, THE SURGEON CLAMPED THE TISSUE (WITH THE DEVICE) AND PERFORMED FIRING OPERATION, BUT THE DEVICE WAS UNABLE TO FIRE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503554 ↗

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 tra
• 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-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-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-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-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-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-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT

…and 58 more.