Endo GIA 030423Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 10884523002980), received between Jun 9, 2017 and Sep 19, 2025 — classified as 18 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (65 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 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A THORACOSCOPIC LEFT UPPER LOBECTOMY, A MANUAL HANDLE WITH A RELOAD WAS USED FOR INTERLOBAR FISSURE DETACHMENT WHEN THE STAPLE BURST OUT, THE STAPLES LACKED PROPER B-SHAPED FORMATION AND THE STAPLE LINE WAS INCOMPLETE, RESULTING IN BLEEDING. AFTER REPLACING THE RELOAD, THE STAPLE LINE REMAINED INCOMPLETE AFTER FIRING AND ADDITIONAL BLEEDING OCCURRED IN THE MIDSECTION. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THESE ISSUES. MANUAL SUTURING WAS PERFORMED UNDER LAPAROSCOPY TO RESOLVE THE INCOMPLETE STAPLE LINE AND BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 23093678 ↗
• MalfunctionAug 20, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SUBTOTAL GASTRECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THEREFORE, THE DEVICE COULD NOT BE FIRED. ANOTHER RELOAD WAS USED, BUT THE SAME ISSUE OCCURRED. A NEW RELOAD WAS USED WITH THE SAME MANUAL HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000989 ↗
• MalfunctionAug 5, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) SEGMENTECTOMY, THE RELOAD DID NOT FIRE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19913320 ↗
• MalfunctionApr 15, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A ESOPHAGECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. A NEW RELOAD WAS USED WITH THE SAME MANUAL HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19110636 ↗
• MalfunctionDec 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT UPPER PULMONARY LOBECTOMY PROCEDURE, AT THE TIME OF DISCONNECTING AND CLOSING THE RIGHT LOWER PULMONARY LOBE, THE DEVICE DID NOT FIRE AFTER THE GREEN BUTTON WAS PRESSED AND THE HANDLE WAS SQUEEZED. 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 18368082 ↗
• MalfunctionJul 28, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION OF RECTAL CANCER, WHEN THE RECTUM WAS SEVERED, THE FIRST TWO RELOADS DID NOT FIRE AFTER PRESSING THE GREEN BUTTON. THE HANDLE COULD NOT BE SQUEEZED AS WELL. A 45MM RELOAD WAS REPLACED AND FIRED; HOWEVER, THE STAPLES DID NOT HAVE A PROPER B SHAPED FORMATION AND THERE WAS BLEEDING. THE SURGEON HAD TO HAND SEWN THE TISSUE TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17411091 ↗
• MalfunctionJun 19, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC SEGMENTECTOMY, WHILE DETACHING LUNG PARENCHYMA, FIRST RELOAD WAS USED. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT UNABLE TO SQUEEZE THE HANDLE AND UNABLE TO FIRE. WHEN THE SECOND RELOAD WAS USED WITH THE SAME HANDLE, DEVICE FIRED, BUT THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE RELOAD WAS REPLACED WITH SAME TYPE AND SAME HANDLE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17152073 ↗
• MalfunctionJun 9, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, AFTER DETACHING THE BLOOD VESSEL, THE DEVICE WAS DIFFICULT TO UNLOAD. THE SURGEON WAS ABLE TO UNLOAD THE DEVICE BY FORCE. A NEW HANDLE WAS THEN USED TO DETACHED THE TRACHEA. HOWEVER, THE STAPLES DID NOT FORM INTO B-SHAPE WHEN THE DEVICE WAS FIRED. THE SURGEON USED A THIRD SET OF HANDLE AND RELOAD TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17101868 ↗
• MalfunctionMay 4, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, DURING THE NEED TO CUT AND CLOSE THE TRACHEA, THE RELOAD WAS LOADED TO THE HANDLE AND THE FIRING BUTTON WAS PRESSED; THE HANDLE COULD NOT BE SQUEEZED AND THE DEVICE DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868082 ↗
• MalfunctionApr 21, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACIC LOBECTOMY, IN DISSOCIATING THE LOBE BRONCHI, THE STAPLE LINE WAS DISTALLY INCOMPLETE. TO RESOLVE THE ISSUE, A NEW RELOAD OF THE SAME TYPE WAS USED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16784480 ↗
• MalfunctionApr 11, 2023Failure to Form Staple; Human-Device Interface Problem; Failure to Form Staple; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, AT THE TIME OF DETACHING TRACHEA, THE STAPLES DID NOT FORM INTO B-SHAPE AND THE DEVICE WAS UNABLE TO UNLOAD. THE SURGEON SUTURED THE STAPLE LINE AND USED A NEW HANDLE TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16715626 ↗
• InjuryFeb 22, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN FIRING ON ANTRUM, THERE WAS AN INCOMPLETE STAPLE LINE AND OPEN STAPLES ON THE PROXIMAL AREA. USED ANOTHER RELOAD TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16418948 ↗
• MalfunctionDec 16, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE PROCEDURE, WHILE STAPLING THE TWO RELOADS 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 15993548 ↗
• MalfunctionDec 8, 2022Misfire; Failure to Fire; Misfire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY PROCEDURE, WHILE STAPLING THE LOBAR BRONCHUS, THE STOPPED FIRING HALFWAY; THE SURGEON COULD NO LONGER SQUEEZE THE HANDLE. A NEW HANDLE AND RELOAD WERE USED TO CONTINUE FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940074 ↗
• InjuryOct 26, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC SEGMENTECTOMY PROCEDURE, WHEN THE STAPLER WAS USED TO DETACH THE LUNG PARENCHYMA, THE STAPLERS FORMED A POORLY B-SHAPE. SUTURES WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15673706 ↗
• MalfunctionSep 9, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LEFT UPPER LOBECTOMY, WHEN THE LEFT UPPER PULMONARY ARTERY AND THE LEFT UPPER LOBE INTERLOBAR FISSURE WERE DETACHED, THE DEVICE WAS ABLE TO FIRE ONE OF THE RELOADS BUT HAD A POOR STAPLE FORMATION, THE SHAPE OF THE STAPLE WAS NOT GOOD AND THE SUBSEQUENT FIRINGS COULD NOT BE MADE AFTER. THE SURGEON WAS ABLE TO PRESSED THE GREEN BUTTON BUT UNABLE TO SQUEEZED THE HANDLE. BLEEDING OCCURRED WHEN THE LEFT UPPER LOBE ARTERY WAS DETACHED. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397353 ↗
• InjurySep 6, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC SEGMENTECTOMY, WHILE DETACHING THE LUNG SEGMENT, THE STAPLES FORMED POORLY AND THE ANASTOMOTIC SITE EFFECT WAS POOR. THE SURGEON USED SUTURE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15365279 ↗
• InjuryAug 31, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPY, WHEN DETACHING THE LUNG PARENCHYMA, AFTER THE FIRING WAS COMPLETED, THE STAPLES WERE POORLY FORMED. THE USER ADDED SUTURING TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15330133 ↗
• MalfunctionAug 22, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LUNG WEDGE SURGERY, THE THREE RELOADS WOULD FIRED HALFWAY THROUGH. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15269282 ↗
• MalfunctionJul 15, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS IN A RIGHT LOWER THORACOSCOPIC LOBECTOMY, THERE WERE MULTIPLE FIRING ISSUE WITH THE MANUAL STAPLERS USED. HANDLE WAS NOT ABLE TO FIRE AND ALL RELOADS REPORTED HAD POOR STAPLE FORMATION. SURGEON REPLACED THE HANDLE AND RELOAD TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033462 ↗
• MalfunctionMay 12, 2022Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A RIGHT UPPER LOBECTOMY VIA LAPAROSCOPIC PROCEDURE, WHEN THE BRONCHUS WAS DETACHED WITH GREEN STAPLE, THE JAW COULD NOT CLOSE PROPERLY AND COULD NOT BE FIRED. ALTHOUGH THE SURGEON WAS ABLE TO PRESSED THE GREEN BUTTON BUT WAS NOT ABLE TO SQUEEZED THE HANDLE. TO RESOLVE THE ISSUE, THE SURGEON REPLACED THE RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377843 ↗
• MalfunctionFeb 7, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC LEFT LOWER LOBE DETACHMENT OF BRONCHUS IN A LOBECTOMY, SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE. STAPLER WAS NOT ABLE TO FIRE. SURGEON USED A NEW HANDLE AND NEW RELOAD TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471737 ↗
• MalfunctionJan 14, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY, WHILE REMOVING THE PULMONARY LOBE THE DEVICE DID NOT FIRE. THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE EVEN AFTER PRESSING THE GREEN BUTTON. THE SURGEON USED A NEW RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261511 ↗
• MalfunctionJan 5, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC LUNG RESECTION, WHILE CLAMPING THE LUNG LOBES, THE RELOAD COULD NOT BE CLAMPED WHEN PULLING THE GRIP. THE DEVICE DID NOT FIRE - THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS NOT ABLE TO SQUEEZED THE HANDLE. TO RESOLVE THE ISSUE, THE SURGEON REPLACED THE RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173300 ↗
• MalfunctionDec 1, 2021Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IT WAS FOUND THAT THE STAPLE COULD NOT BE OPENED SO IT WAS STOPPED FROM USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909745 ↗

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-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-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-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-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-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-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-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT

…and 58 more.