Endo GIA EGIA45CTAMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10884521138056), received between Aug 12, 2017 and Sep 9, 2025 — classified as 7 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (53 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 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER INTRA-OPERATIVELY, AFTER FIRING THE STAPLE LINE OPENED AND DID NOT HOLD. THE STAPLE LINE RESECTED AND RE-STAPLED WITH A NEW DEVICE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23004988 ↗
• MalfunctionFeb 25, 2025Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE OF A DEVICE, THE RELOAD WAS DIFFICULT TO STRAIGHTEN OR RETURN TO NEUTRAL POSITION. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE AND ADAPTER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461996 ↗
• MalfunctionJan 7, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A THORACOSCOPIC LOBECTOMY PROCEDURE, THE DEVICE WAS BEING APPLIED TO TRANSECT THE LOBAR BRONCHUS WHEN THE STAPLER COULD NOT BE FIRED, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. TO RESOLVE THE PROBLEM AND COMPLETE THE PROCEDURE, A NEW RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093335 ↗
• MalfunctionOct 8, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) PROCEDURE, THE RELOAD BLADE DID NOT PROGRESS AND IT WAS STUCK. THERE WAS NO STAPLES WERE DEPLOYED. 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 20402444 ↗
• MalfunctionSep 11, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A THORACOSCOPIC RIGHT LUNG LOBECTOMY, WHEN THE RIGHT LOWER LOBE BRONCHUS WAS DETACHED, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER RELOAD AND HANDLE WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20188637 ↗
• MalfunctionJul 3, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE POWERED STAPLER PARTIALLY FIRED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665562 ↗
• MalfunctionApr 9, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLER DID NOT FIRE. 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 19072435 ↗
• MalfunctionApr 9, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072147 ↗
• MalfunctionMar 26, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LOW ANTERIOR RESECTION, THERE WAS POOR STAPLE FORMATION. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS AFTER USING A NEW PRODUCT.

  Patient problems: Tissue Breakdown

  MAUDE report 18980373 ↗
• MalfunctionMar 7, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE JAW DID NOT BEND TO ITS MAXIMUM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859816 ↗
• MalfunctionJan 12, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18506350 ↗
• MalfunctionJan 4, 2024Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LOBECTOMY, ON RESECTION OF THE LUNG LOBE, THE FIRST HANDLE WAS USED WITH A PURPLE RELOAD AND FIRED HALFWAY ACROSS THE TUMOR BUT WAS NOT ABLE TO FIRE ACROSS FULLY IN THE TISSUE. A SECOND HANDLE WAS USED WITH BLACK RELOAD BUT THE SAME ISSUE OCCURRED. A THIRD RELOAD WAS USED AND STILL THE SAME ISSUE OCCURRED. THE STAPLE FORMATION WAS INCOMPLETE AND NO B SHAPE FORMATION RESULTED ON THE SPECIMEN. THE JAWS OF THE DEVICE LOCKED ON TISSUE AND WAS REMOVED NORMALLY. ANOTHER MANUFACTURER'S PRODUCT WAS USED TO RESOLVE THE ISSUE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE RELOAD WAS PARTIALLY FIRED TO THE 2CM CUT LINE. THE CLAMPING MECHANISM WAS DEFORMED.

  Patient problems: Tissue Breakdown

  MAUDE report 18445206 ↗
• MalfunctionDec 11, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY, THE STAPLER DID NOT FIRE. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS AFTER USING THE NEW HANDLE AND RELOAD.

  Patient problems: Insufficient Information

  MAUDE report 18302920 ↗
• MalfunctionOct 31, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER INSTALLING THE DEVICE, IT WAS FOUND OUT THE RELOAD WAS BROKEN. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044536 ↗
• MalfunctionOct 12, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC LOBECTOMY, DURING THE TRANSECTION OF BRONCHUS, THE FIRST STAPLER USED JAMMED MIDWAY THROUGH FIRING. THE HANDLE JAMMED WITH TWO 60MM PURPLE CURVED RELOADS. ANOTHER HANDLE WAS OPENED BUT THE SAME ISSUE OCCURRED. THE SECOND HANDLE JAMMED USING TWO 45MM CURVE-TIPPED RELOADS. THE SURGEON THEN SWITCHED TO A BLACK 45MM RELOAD BUT THE ISSUE STILL OCCURRED. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 17927890 ↗
• MalfunctionOct 12, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC LOBECTOMY, DURING THE TRANSECTION OF BRONCHUS, THE FIRST STAPLER USED JAMMED MIDWAY THROUGH FIRING. THE HANDLE JAMMED WITH TWO 60MM PURPLE CURVED RELOADS. ANOTHER HANDLE WAS OPENED BUT THE SAME ISSUE OCCURRED. THE SECOND HANDLE JAMMED USING TWO 45MM CURVE-TIPPED RELOADS. THE SURGEON THEN SWITCHED TO A BLACK 45MM RELOAD BUT THE ISSUE STILL OCCURRED. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 17926944 ↗
• MalfunctionSep 14, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY, THE DISTAL PART OF THE CARTRIDGE WAS INCOMPLETELY FIRED. THE RELOAD WAS REPLACED WITH OTHER PRODUCT FROM THE SAME COMPANY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 17745732 ↗
• MalfunctionJul 28, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RELOAD BROKE AFTER BEING INSTALLED AND USED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17416674 ↗
• MalfunctionJun 15, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE STAPLER DID NOT FIRE. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139228 ↗
• MalfunctionJan 27, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, THERE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254440 ↗
• MalfunctionJan 9, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA 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 16125889 ↗
• MalfunctionDec 13, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, IN SEVERING THE BRONCHUS, THE SURGEON WAS ABLE TO PRESSED THE GREEN BUTTON. HOWEVER, THE HANDLE COULD NOT BE SQUEEZED. THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15972345 ↗
• MalfunctionSep 6, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DID NOT FIRE. THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15364457 ↗
• MalfunctionAug 12, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY, WHEN BLOOD VESSEL WAS GOING TO DETACH, THE STAPLER WAS NOT ABLE TO FIRE. A NEW RELOAD WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222397 ↗
• MalfunctionAug 12, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEPATECTOMY PROCEDURE, AT THE TIME WHEN HEPATIC PEDICLE DETACHED, THE STAPLER WAS UNABLE TO FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222348 ↗

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-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-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-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-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-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-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-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

…and 58 more.