Endo GIA Ultra EGIAUXLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2,909 adverse event reports that list this exact device (DI 10884523003550), received between Sep 8, 2016 and Sep 28, 2026 — classified as 177 injuries, 2,732 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (1,635 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 2,909 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917936 ↗
• MalfunctionSep 22, 2026Misfire; Human-Device Interface Problem

  It was reported that during a lobectomy, when the pulmonary vessel was dissected, partial firing was observed. The green button was stiff from the start. Another reload and manual handle were replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849727 ↗
• MalfunctionSep 18, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829161 ↗
• MalfunctionSep 15, 2026Component or Accessory Incompatibility; Mechanical Jam; Insufficient Device Problem Information

  According to the reporter, during a procedure, prior to patient use, the device jammed and the reload was locked and unable to be loaded. A new product was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766577 ↗
• MalfunctionAug 27, 2026Failure to Fire

  It was reported that preoperatively the doctor could not fire the device and when tried, it got stuck. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474549 ↗
• MalfunctionAug 12, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223963 ↗
• MalfunctionAug 12, 2026Failure to Fire; Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221915 ↗
• MalfunctionAug 10, 2026Difficult to Open or Close

  According to the reporter, during a robotic laparoscopic wedge resection of the lung, during  setup, after loading the reload and not on the tissue yet, the jaws did not close. A new handle with the same reload was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191621 ↗
• MalfunctionJun 13, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING A ROBOTIC LIVER RESECTION PROCEDURE, AFTER FIRING, THE STAPLES FIRED BUT WHEN THE SURGEON ATTEMPTED TO RETRACT THE KNIFE BLADE/OPEN THE JAWS AND REMOVE THE DEVICE FROM TISSUE, THE JAWS OF THE RELOAD WOULD NOT OPEN, AND THE DEVICE WAS LOCKED ON TISSUE AND COULD NOT BE REMOVED. THE RELOAD AND STAPLER WERE RESECTED OUT USING ANOTHER STAPLER, AND THE ISSUE WAS ADDRESSED BY RESECTING AND RE-STAPLING. THE PROCEDURE WAS EXTENDED BY 30 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 25494777 ↗
• MalfunctionMay 27, 2026Failure to Fire

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE PLIERS SNAPPED IN THE HANDLE, BUT IT DID NOT STAPLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25297736 ↗
• MalfunctionMay 27, 2026Break; Failure to Fire

  ACCORDING TO THE REPORTER DURING A SLEEVE GASTRECTOMY, THE PLIERS BROKE AND NO LONGER STAPLED NORMAL TISSUE THICKNESS. ANOTHER HANDLE HAD THE SAME ISSUE. A THIRD MANUAL HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25297639 ↗
• MalfunctionMay 27, 2026Break; Failure to Fire

  ACCORDING TO THE REPORTER DURING A SLEEVE GASTRECTOMY, THE PLIERS BROKE AND NO LONGER STAPLED NORMAL TISSUE THICKNESS. ANOTHER HANDLE HAD THE SAME ISSUE. A THIRD MANUAL HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25297589 ↗
• MalfunctionMay 20, 2026Break; Firing Problem

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE STAPLER WAS DIFFICULTY TO FIRE. BOTH HANDLE AND RELOAD WERE REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND SHEARED TEETH ON THE FIRING RACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230733 ↗
• MalfunctionMay 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE HANDLE HAD AN UNKNOWN ISSUE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE INSTRUMENT LOADED, CLAMPED, YET WOULD NOT CYCLE DUE TO THE SHEARED FIRING RACK TEETH DAMAGE. AN ACCESS HOLE WAS CUT INTO THE INSTRUMENT BODY FOR VISUALIZATION OF THE FIRING RACK. SHEARED TEETH WERE VISIBLE ON THE FIRING RACK AT SITE OF INITIAL FIRING POST CLAMP UP.

  Patient problems: Insufficient Information

  MAUDE report 25152699 ↗
• MalfunctionMay 5, 2026Break; Device Slipped

  IT WAS REPORTED THAT DURING AN APPENDECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON AND SQUEEZE THE HANDLE OF THE STANDARD STAPLER, BUT THE HANDLE WAS RUNNING IDLE OR SHOWING NO RESISTANCE. HENCE, THE DEVICE DID NOT FIRE. A SECOND RELOAD WAS THEN USED BUT THE SAME ISSUE OCCURRED. A DIFFERENT TYPE OF HANDLE WAS THEN USED WITH SAME RELOAD, BUT THE SAME PROBLEM STILL PERSISTED. TO RESOLVE THE ISSUE, THE SURGEON ULTIMATELY PERFORMED THE SUTURE MANUALLY AS NO ADDITIONAL UNITS WERE AVAILABLE. THE PROCEDURE WAS EXTENDED BY 20 MINUTES DUE TO THESE ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE INSTRUMENT LOADED, CLAMPED, YET WOULD NOT CYCLE DUE TO THE SHEARED F IRING RACK TEETH DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083863 ↗
• MalfunctionMay 5, 2026Failure to Fire

  ACCORDING TO THE REPORTER DURING AN OPEN LOW ANTERIOR RESECTION, WHILE USING THE FIRST STAPLER, THE SURGEON PRESSED THE GREEN BUTTON AND SQUEEZED THE HANDLE, BUT THE DEVICE DID NOT FIRE. A SECOND RELOAD WAS USED WITH THE SAME HANDLE AND THE SAME ISSUE OCCURRED. A NEW HANDLE AND RELOAD FROM A DIFFERENT MANUFACTURER WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076827 ↗
• MalfunctionApr 30, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, IN THE ILEOCOLIC ARTERY OR CECUM, THE STAPLER DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044691 ↗
• MalfunctionApr 10, 2026Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT FIRE DURING BARIATRIC PROCEDURE. THE USER HAD TO GET HANDLE UNIT TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841693 ↗
• MalfunctionApr 2, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE THE INSTRUMENT DID NOT FIRE. IT WAS NOTED THAT TWO RELOADS WERE USED AND HAD THE SAME ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767483 ↗
• MalfunctionMar 24, 2026Break; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, THE STAPLER BREAKS AND NO LONGER STAPLES TO NORMAL TISSUE THICKNESS. IT WAS NOTED THAT TWO DEVICES WERE USED AND HAD THE SAME ISSUE. ANOTHER MANUAL HANDLE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682559 ↗
• MalfunctionMar 24, 2026Break; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, THE STAPLER BREAKS AND NO LONGER STAPLES TO NORMAL TISSUE THICKNESS. IT WAS NOTED THAT TWO DEVICES WERE USED AND HAD THE SAME ISSUE. ANOTHER MANUAL HANDLE WAS USED TO THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676647 ↗
• MalfunctionMar 9, 2026Entrapment of Device; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC WHIPPLE PROCEDURE OR LIVER RESECTION, WHILE TRANSECTING THE LIVER, THE DEVICE FIRED COMPLETELY, BUT THERE WAS AN INCOMPLETE STAPLE LINE AT THE DISTAL END. ADDITIONALLY, THE JAWS WERE STUCK IN THE MIDDLE WHEN IT WAS ATTEMPTED TO OPEN. THE SURGEON HAD TO FORCE OPEN THE JAWS WITH DIFFICULTY. TO COMPLETE THE CASE, A NEW HANDLE WAS USED FOR RESECTION AND RESTAPLE.

  Patient problems: Insufficient Information

  MAUDE report 24551398 ↗
• MalfunctionFeb 22, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PULMONARY LOBECTOMY, THE STAPLES WERE NOT RELEASED FROM THE CLAMP. THE RELOAD WAS REPLACED WITH ANOTHER FROM THE SAME LOT, YET HAD THE SAME ISSUE PERSISTED. THE HANDLE WAS REPLACED AS WELL BUT THE ISSUE STILL PERSISTED SO THEY SWITCHED TO A BLACK RELOAD, WHICH THEN WORKED. SURGICAL TIME WAS EXTENDED BY AN HOUR DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410980 ↗
• MalfunctionFeb 17, 2026Break; Misfire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE HANDLES BROKE AND CRACKED. THE SURGEON ATTEMPTED MULTIPLE RELOADS AND WENT FROM PURPLE TO BLACK ON THE ANTRUM OF THE STOMACH, YET THE SURGEON COULD NOT FIRE THROUGH ONE AREA OF THE STOMACH; IT WAS PARTIALLY FIRED. AFTER MULTIPLE ATTEMPTS, THE SURGEON MOVED LATERAL AND COMPLETED THE SLEEVE WITH NO ISSUES. THE SURGEON OVERSEWED THE STAPLE LINE AT THE AREA.

  Patient problems: Tissue Breakdown

  MAUDE report 24372642 ↗
• MalfunctionFeb 17, 2026Break; Misfire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE HANDLES REPORTEDLY BROKE AND CRACKED. THE SURGEON ATTEMPTED MULTIPLE RELOADS AND WENT FROM PURPLE TO BLACK ON THE ANTRUM OF THE STOMACH, YET THE SURGEON COULD NOT FIRE THROUGH ONE AREA OF THE STOMACH; IT WAS PARTIALLY FIRED. AFTER MULTIPLE ATTEMPTS, THE SURGEON MOVED LATERAL AND COMPLETED THE SLEEVE WITH NO ISSUES. THE SURGEON OVERSEWED THE STAPLE LINE AT THE AREA.

  Patient problems: Tissue Breakdown

  MAUDE report 24372506 ↗

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-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-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-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-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-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-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-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-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
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT

…and 58 more.