Endo GIA EGIA60CTAMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 10884523003246), received between Sep 7, 2017 and Sep 22, 2026 — classified as 5 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (54 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 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Adverse Event Without Identified Device or Use Problem

  According to the reporter, during the procedure, there was an issue with reload after firing the device, and staple line bleeding was observed. To resolve the issue, the reload was replaced.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50855297 ↗
• MalfunctionApr 2, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, STAPLER JAWS FAILED TO CLOSE. THE RELOAD WAS REPLACED AND USED IT ON THE SAME HANDLE TO RESOLVE THE ISSUE.NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766061 ↗
• MalfunctionJan 16, 2026Failure to Fire

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE PRODUCT DID NOT WORK AS INTENDED. THE RELOAD WAS REPLACED WITH A NEW ONE, AND THE SURGERY PROCEEDED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092674 ↗
• MalfunctionDec 25, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION (LAP LAR) PROCEDURE, WHILE CLAMPING THE COLON, THE RELOAD JAWS WAS NOT CLOSING COMPLETELY PRIOR TO FIRING. THE SURGEON USED ANOTHER RELOAD OF THE SAME TYPE TO RESOLVE THIS ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891786 ↗
• MalfunctionDec 15, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY (DIAGNOSTIC LAPAROTOMY), THE INSTRUMENT DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON AND SQUEEZE THE HANDLE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809791 ↗
• MalfunctionDec 5, 2025Misfire; Component or Accessory Incompatibility; Misfire; Component or Accessory Incompatibility

  IT WAS REPORTED THAT THE RELOAD COULD NOT BE LOADED INTO THE ADAPTER. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT THE RELOAD WAS PARTIALLY FIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727357 ↗
• MalfunctionNov 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE RELOAD HAD AN UNKNOWN ISSUE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED. STAPLE PUSHERS WERE VISIBLE AT THE 2.5CM CUT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559698 ↗
• MalfunctionNov 3, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING LOBECTOMY, THE CURVED RELOAD DID NOT CLOSE COMPLETELY WHEN INSERTED INTO THE STAPLER. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451866 ↗
• MalfunctionOct 15, 2025Difficult to Open or Close; Human-Device Interface Problem; Difficult to Open or Close; Human-Device Interface Problem

  ACCORDING TO THE REPORTER PRIOR TO USE, WHEN IT WAS ATTEMPTED TO USE THE CARTRIDGE INTO THE MANUAL STAPLER, IT DID NOT CLOSE. THE STAPLE TIP COULD NOT BE REMOVED AND IT WAS IMPOSSIBLE TO OPERATE THE STAPLER AFTER ATTEMPTS WERE MADE. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287849 ↗
• MalfunctionSep 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THORACOSCOPIC LUNG LOBE SURGERY, WHILE DETACHING THE TISSUE, THE RELOAD WAS UNABLE TO FIRE AND THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. THE DEVICE WAS REPLACED WITH A NEW STAPLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092646 ↗
• MalfunctionAug 21, 2025Misfire; Firing Problem; Misfire; Firing Problem

  IT WAS REPORTED THAT THE RELOAD EXPERIENCED FIRING ISSUES AND WAS DIFFICULT TO FIRE WHEN USED WITH A POWERED STAPLER AND STANDARD ADAPTER. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW PRODUCT. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE PARTIAL FIRE CONDITION WITH INTERLOCK ENGAGEMENT MAY OCCUR WHEN THE FIRING HANDLE HAS NOT BEEN COMPLETELY CYCLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866447 ↗
• MalfunctionAug 5, 2025Break; Firing Problem; Break; Firing Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RELOAD WAS DIFFICULT TO FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT THE CLAMPING MECHANISM WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716047 ↗
• MalfunctionJul 24, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING USE OF THE TWO RELOADS, PARTIAL FIRE WERE OBSERVED. THE DEVICES WERE REPLACED WITH NEW PRODUCTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22586458 ↗
• MalfunctionJul 1, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE DEVICE DID NOT FIRE DURING USE. THE DEVICE WAS REPLACED WITH A NEW RELOAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371539 ↗
• MalfunctionJun 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A VATS LOBECTOMY THORACOSCOPY, BRONCHIAL SEGMENTATION, THERE WAS DAMAGE TO THE CONNECTION PART (SHAFT) OF THE RELOAD. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298773 ↗
• MalfunctionMay 16, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SUBTOTAL COLECTOMY PROCEDURE, IN COLON ANASTOMOSIS IN SMALL PELVIC SPACES, ON TWO RELOADS, SOME OF THE STAPLES FAILED TO FORM PROPERLY. VISUALLY, SOME OF THE B-SHAPED STAPLES WERE STILL ON THE PROXIMAL PART OF THE RELOAD. TO RESOLVE THE ISSUE, CLIPS WERE USED.

  Patient problems: Tissue Breakdown

  MAUDE report 22040624 ↗
• MalfunctionMay 16, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SUBTOTAL COLECTOMY PROCEDURE, IN COLON ANASTOMOSIS IN SMALL PELVIC SPACES, ON TWO RELOADS, SOME OF THE STAPLES FAILED TO FORM PROPERLY. VISUALLY, SOME OF THE B-SHAPED STAPLES WERE STILL ON THE PROXIMAL PART OF THE RELOAD. TO RESOLVE THE ISSUE, CLIPS WERE USED.

  Patient problems: Tissue Breakdown

  MAUDE report 22040619 ↗
• MalfunctionMar 20, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT THE PREOPERATIVELY, ON THREE DEVICES, THE JAWS WERE NOT FULLY OPENED, AND BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655307 ↗
• MalfunctionMar 20, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT THE PREOPERATIVELY, ON THREE DEVICES, THE JAWS WERE NOT FULLY OPENED, AND BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655141 ↗
• MalfunctionMar 19, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE JAWS OF THE DEVICE WAS NOT CLOSING PROPERLY. ADDITIONALLY, THE JAWS OF THE RELOAD BROKE. 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 21649078 ↗
• MalfunctionMar 19, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT PREOPERATIVELY, ON THREE DEVICES, THE JAWS WERE NOT FULLY OPEN AND BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647641 ↗
• MalfunctionFeb 18, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHILE ON SET-UP, THE JAWS OF THE DEVICE WOULD NOT CLOSE COMPLETELY. ANOTHER DEVICE WITH DIFFERENT LOT# WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403114 ↗
• MalfunctionFeb 3, 2025Difficult to Open or Close; Difficult to Open or Close

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300301 ↗
• MalfunctionFeb 3, 2025Difficult to Open or Close; Difficult to Open or Close

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300297 ↗
• MalfunctionJan 30, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE CUTTING AT THE LOCATION NEAR CECUM INVOLVING THE EGIA60CTAMT CURVED MED THICK SULU RELOAD AND THE EGIAUSTND ENDOGIA ULTRA UNIVERSAL STANDARD STAPLER HANDLE, THERE WAS A GAP OF THE CARTRIDGE BEING WIDER THAN USUAL WHEN CLOSED, WHICH CAUSED TISSUE TO SLIP OUT. THE ISSUE WAS RESOLVED BY REPLACING BOTH THE CARTRIDGE AND THE STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276299 ↗

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-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-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-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-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-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT

…and 58 more.