Endo GIA EGIA60AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 10,680 adverse event reports that list this exact device (DI 10884523003215), received between Jan 26, 2016 and Sep 30, 2026 — classified as 19 deaths, 1,119 injuries, 9,542 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (4,627 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 10,680 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952420 ↗
• MalfunctionSep 30, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952320 ↗
• MalfunctionSep 30, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950140 ↗
• MalfunctionSep 29, 2026Break; Misfire; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941198 ↗
• MalfunctionSep 29, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50937332 ↗
• MalfunctionSep 29, 2026Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937174 ↗
• MalfunctionSep 29, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50937140 ↗
• MalfunctionSep 29, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936995 ↗
• MalfunctionSep 29, 2026Mechanics Altered

  Patient problems: Tissue Breakdown

  MAUDE report 50936740 ↗
• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936622 ↗
• MalfunctionSep 29, 2026Break; Failure to Fire

  It was reported that during anterior resection of rectum, once the reload was loaded and inserted through the trocar, it could not be activated. After several attempts, it was removed. A small metal tab was protruding from the side of the reload and was not visible on a new reload.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935016 ↗
• MalfunctionSep 29, 2026Failure to Fire

  It was reported that during a procedure, while on gastric body resection, the firing could not be performed at all. A new device was replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929247 ↗
• MalfunctionSep 28, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924178 ↗
• MalfunctionSep 28, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924012 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: Laceration(s)

  MAUDE report 50923868 ↗
• MalfunctionSep 28, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923806 ↗
• MalfunctionSep 28, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918254 ↗
• MalfunctionSep 28, 2026Failure to Fire

  According to the reporter, intra-operatively of a laparoscopic appendectomy, during the transection of the ileocecal region, the sur geon was able to press the green button and squeeze the handle, but the device did not fire. Another device was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912308 ↗
• MalfunctionSep 24, 2026Failure to Cycle; Misfire; Failure to Form Staple

  It was reported that during a gastric bypass procedure, the surgeon positioned the stapler on the tissue to create the gastric pouch. Upon the third firing, after noting that the indicator read "1", the surgeon began to fire, but midway through the firing, the tissue began to bunch up, the staples started to deform, and the blade failed to advance. The issue was managed by resecting and re-stapling the tissue.

  Patient problems: Tissue Breakdown

  MAUDE report 50877000 ↗
• MalfunctionSep 24, 2026Misfire

  It was reported that during an open colon resection, partial firing had occurred. The firing stopped once staples reached the tissue. The power handle was replaced after the multiple failed reloads. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876936 ↗
• MalfunctionSep 24, 2026Misfire

  It was reported that during an open colon resection, partial firing had occurred. The firing stopped once staples reached the tissue. The power handle was replaced after the multiple failed reloads. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876930 ↗
• MalfunctionSep 24, 2026Misfire

  It was reported that during an open colon resection, partial firing had occurred. The firing stopped once staples reached the tissue. The power handle was replaced after the multiple failed reloads. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876926 ↗
• MalfunctionSep 23, 2026Misfire; Expulsion

  According to the reporter, during a procedure, prior to use, the cartridge has a staple protruding out. A new stapler was used to resolve the issue. There was no patient injury. Medtronic's initial evaluation of the incident is that the reload was partially fired.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868702 ↗
• MalfunctionSep 23, 2026Misfire

  It was reported that during an open colon resection, partial firing had occurred. The firing stopped once staples reached the tissue. The power handle was replaced after the multiple failed reloads. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863655 ↗
• MalfunctionSep 22, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50860034 ↗

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-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-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-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-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-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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT

…and 58 more.