Endo GIA EGIA45AMT (UDI 10884523003154)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,965 adverse event reports that list this exact device (DI 10884523003154), received between May 23, 2016 and Sep 28, 2026 — classified as 10 deaths, 325 injuries, 2,630 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (1,583 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 2,965 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924898 ↗
• MalfunctionSep 23, 2026Misfire

  According to the reporter, during a laparoscopic appendectomy procedure, the knife advanced first. A new handle and reload were used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864422 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859384 ↗
• MalfunctionSep 18, 2026Failure to Fire; Expulsion

  According to the reporter, during a thoracoscopic right partial lung resection, during parenchymal resection, after closing the jaws,  the green button was pressed but the firing could not be done at all. The staples came out around the proximal side of the jaws. A new reload was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816978 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50599844 ↗
• MalfunctionAug 26, 2026Difficult to Open or Close

  Patient problems: Insufficient Information

  MAUDE report 50460223 ↗
• MalfunctionAug 24, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421776 ↗
• MalfunctionAug 24, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420767 ↗
• MalfunctionAug 24, 2026Misfire; Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50418419 ↗
• MalfunctionAug 24, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416595 ↗
• MalfunctionAug 17, 2026Failure to Fire; Expulsion

  According to the reporter, during a laparoscopic rectal resection, when the jaws were closed and after pressing the green button, the firing could not be performed at all. A stapling near the proximal side of the cartridge's jaws was found after the firing attempt. A new cartridge was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50275606 ↗
• MalfunctionAug 16, 2026Misfire

  It was reported that during a procedure, the reload had a firing issue and was reported as not working. A new 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 50267715 ↗
• MalfunctionAug 14, 2026Entrapment of Device; Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251333 ↗
• MalfunctionAug 12, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221597 ↗
• MalfunctionAug 12, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220212 ↗
• MalfunctionAug 12, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220203 ↗
• MalfunctionAug 12, 2026Entrapment of Device; Human-Device Interface Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50219740 ↗
• MalfunctionAug 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 50204928 ↗
• MalfunctionJul 30, 2026Failure to Form Staple

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 50093780 ↗
• MalfunctionJul 7, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, THE JAWS WERE CLOSED AND THE GREEN BUTTON WAS PRESSED BUT THE FIRING COULD NOT BE DONE AT ALL. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25734783 ↗
• MalfunctionJun 29, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT, DURING A LUNG SEGMENTECTOMY PROCEDURE, THE RELOAD CONNECTED TO THE ADAPTER BECAME STUCK CLOSED UPON FIRING AND WOULD NOT OPEN, REMAINING LODGED IN THE PATIENT. IT WAS ALSO REPORTED THAT THE RELOAD SHAFT BROKE, AND THE BROKEN PART DID NOT DISENGAGE. THE SURGICAL TIME WAS EXTENDED BY 40 MINUTES. THE DEVICES WERE REPLACED WITH ANOTHER DEVICE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 25661629 ↗
• MalfunctionJun 15, 2026Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC LOBECTOMY, AT THE TIME OF LOBAR TRANSECTION, THE STAPLER DID NOT FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 25498026 ↗
• MalfunctionJun 5, 2026Retraction Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, AFTER FIRING TO RESECT THE RECTUM, THE KNIFE BLADE WAS DIFFICULT TO RETRACT. THE SURGEON SQUEEZED THE HANDLE OF THE STAPLER AGAIN TO RETRACT THE KNIFE TO RESOLVE THE ISSUE, AND THE HANDLE WORKED NORMALLY WITH A NEW RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411281 ↗
• MalfunctionJun 4, 2026Entrapment of Device; Retraction Problem; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRING WAS INTERRUPTED AT THE BEGINNING, IT WAS ALSO DIFFICULT TO RETRACT THE KNIFE BLADE AND THE DEVICE WAS LOCKED ON TISSUE. ADDITIONALLY, AT THE ONSET OF THE CARTRIDGE FIRING SEQUENCE, WHEN THE ERROR OCCURRED, THE FOLLOWING INFORMATION WAS DISPLAYED ON THE SCREEN: WITHIN THE POWERED STAPLER BLOCK, THE STATUS APPEARED IN GREEN; WITHIN THE ADAPTER BLOCK, IT APPEARED IN BLACK WITH A GREEN BORDER; AND WITHIN THE CARTRIDGE BLOCK, A CARTRIDGE ICON WAS DISPLAYED ALONGSIDE A YELLOW TRIANGLE CONTAINING A SYMBOL INDICATING THAT THE TISSUE HAD DRIED OUT, THEREBY NECESSITATING MANUAL SUTURING USING THE DEVICE. THE SURGEON WAS COMPELLED TO PERFORM A TISSUE RESECTION ON THE BRONCHUS, LARGER THAN NECESSARY IN ORDER TO REMOVE THE LOAD AND ADAPTER, WHICH LED TO EXTENDED SURGICAL TIME OF MORE THAN THREE HOURS.

  Patient problems: Tissue Breakdown

  MAUDE report 25403170 ↗
• MalfunctionJun 3, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A GALLBLADDER PROCEDURE, AFTER PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZE AND THE FIRING COULD NOT BE DONE. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375519 ↗

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-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-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-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-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-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-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-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-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-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT

…and 58 more.