Endo GIA 030457Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 10884523002881), received between Mar 30, 2017 and Mar 23, 2026 — classified as 44 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (40 reports).

1 FDA recall record name this device's identifier.

72 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.

Recalls naming this device

1. Apr 26, 2018Class IITerminated

   Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

   Z-1819-2018 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A THORACOSCOPIC RIGHT LOWER LOBECTOMY, WHEN DETACHING THE PULMONARY HILUM AND PULMONARY VEIN, THE TWO RELOADS FIRING WERE OBSTRUCTED. THE ISSUE WAS RESOLVED BY REPLACING THE RELOADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660746 ↗
• MalfunctionJan 12, 2026Break; Entrapment of Device; Unintended System Motion; Misfire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN IN THE CAVITY, THE STAPLER WAS STUCK AND WHEN TRYING TO FIRE IT WOULD NOT WORK. SUDDENLY TURNING RIGHT TO LEFT. WHEN THE STAPLER RELOAD WAS ATTEMPTED TO BE REMOVED IT BROKE AT THE JUNCTION WITH THE ADAPTER.

  Patient problems: Insufficient Information

  MAUDE report 24045584 ↗
• MalfunctionDec 3, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE CARTRIDGE WAS BENT.

  Patient problems: Insufficient Information

  MAUDE report 23702350 ↗
• MalfunctionNov 12, 2025Unintended System Motion; Failure to Fire; Detachment of Device or Device Component; Human-Device Interface Problem; Unintended System Motion; Failure to Fire; Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A LIVER RESECTION, THE DEVICE WOULD ONLY ANGULATE BUT WOULD NOT FIRE. IT WAS NOTED THAT THE DEVICE WAS SUDDENLY TURNING RIGHT TO LEFT. THE JUNCTION BETWEEN THE ADAPTER AND RELOAD BROKE OFF AFTER THE SURGEON RETURNED THE HANDLE TO THE NURSE WHO WAS ATTEMPTING TO REMOVE THE RELOAD. THE DEVICE WAS REPLACED WITH A MANUAL HANDLE AND A NEW RELOAD. IT WAS NOTED THAT THE HANDLE HAD NO ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534751 ↗
• MalfunctionJan 3, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RECTAL CANCER SURGERY, WHEN CLOSING THE LOW RECTAL INCISION, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON HOWEVER THE HANDLE COULD NOT BE SQUEEZED AND THEREFORE 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 21066344 ↗
• MalfunctionNov 27, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL RESECTION OF ESOPHAGOGASTRIC JUNCTION CANCER, A STAPLER WAS USED WHEN THE DUODENUM WAS DETACHED. THE SUTURE LINE WAS INCOMPLETE, THE STAPLES DID NOT FORM INTO A GOOD B-SHAPE, BLEEDING OCCURRED, AND IT WAS FINALLY SUTURED MANUALLY. DURING THE R-Y ANASTOMOSIS OF THE ESOPHAGUS AND JEJUNUM, THE CIRCULAR STAPLER COULD NOT BE FIRED NORMALLY. THE OPERATION WAS COMPLETED AFTER REPLACING IT WITH A NEW HANDLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20801497 ↗
• MalfunctionNov 12, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOT ABLE TO FIRE FOR BOTH DEVICE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667935 ↗
• MalfunctionNov 12, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOT ABLE TO FIRE FOR BOTH DEVICE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666473 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON THE SECOND DAY AFTER SURGERY, THE PATIENT BEGAN TO HAVE SYMPTOMS THAT POINTED TO HEMORRHAGE. THERE WAS STAPLE LINE BLEEDING. THE PATIENT WAS EMBOLIZED ON THE SECOND DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20471524 ↗
• MalfunctionOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A RADICAL NEPHRECTOMY, AFTER FIRING THE RELOAD INTO THE VENA CAVA, THE STAPLE LINE WAS BLEEDING. THE SURGEON HAD TO REINFORCE IT WITH CLIPS.

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20463892 ↗
• MalfunctionSep 13, 2024Entrapment of Device; Firing Problem; Entrapment of Device; Firing Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE FIRST RELOAD WAS FIRED FOR A HALF AND NEAR THE LAST 15MM. WITH NO PROPER STAPLE LINE FORMATION. IT WAS MENTIONED THAT THE JAW OF THE SECOND RELOAD GOT STUCK AND WAS UNABLE TO OPEN IN THE MIDDLE OF THE FIRING. THE JAW OF THE SECOND RELOAD HAD TO BE OPEN USING ANOTHER HAND INSTRUMENTS. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20213513 ↗
• MalfunctionAug 15, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, DURING THE RIGHT COLECTOMY, THE TWO ENDS OF INTESTINE WERE CUT AND STAPLED HOWEVER THE TISSUE SLIPPED FROM THE RELOAD BEFORE THE JAWS WERE OPENED. THE SURGEON DID AN INTESTINAL RECUT WITH ANOTHER RELOAD WHICH DID THE SAME THING. THE SURGEONS DECIDES IT WAS FINALLY GOOD AND THE CASE WAS COMPLETED.

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

  MAUDE report 19996104 ↗
• MalfunctionAug 15, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, DURING THE RIGHT COLECTOMY, THE TWO ENDS OF INTESTINE WERE CUT AND STAPLED HOWEVER THE TISSUE SLIPPED FROM THE RELOAD BEFORE THE JAWS WERE OPENED. THE SURGEON DID AN INTESTINAL RECUT WITH ANOTHER RELOAD WHICH DID THE SAME THING. THE SURGEONS DECIDES IT WAS FINALLY GOOD AND THE CASE WAS COMPLETED.

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

  MAUDE report 19996091 ↗
• MalfunctionJul 9, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN AN OPEN RADICAL PANCREATICODUODENECTOMY, WHEN DETACHING THE DUODENUM, THE STAPLES DID NOT FORM A GOOD B-SHAPE AND THE ANASTOMOSIS WAS BLEEDING. THE STAPLE LINE WAS ALSO INCOMPLETE CENTRALLY. THE STAPLE LINE WAS MANUALLY SUTURED TO FIX THE ISSUE.

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

  MAUDE report 19701888 ↗
• MalfunctionJul 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A RYGB (ROUX-EN-Y-GASTRIC BYPASS) PROCEDURE, WHILE INSERTING THE DEVICE INTO THE ABDOMEN WITHOUT TENSION, THE CONNECTING PART OF THE TWO RELOADS BROKE. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THE ISSUE LED TO EXTENDED SURGICAL TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666394 ↗
• MalfunctionJul 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A RYGB (ROUX-EN-Y-GASTRIC BYPASS) PROCEDURE, WHILE INSERTING THE DEVICE INTO THE ABDOMEN WITHOUT TENSION, THE CONNECTING PART OF THE TWO RELOADS BROKE. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THE ISSUE LED TO EXTENDED SURGICAL TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666310 ↗
• MalfunctionApr 10, 2024Entrapment of Device; Insufficient Device Problem Information; Entrapment of Device; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING AN ENLARGED NEPHRECTOMY PROCEDURE, IN SECTION LIGATION OF THE RIGHT RENAL PEDICLE, THERE WAS A CUTTING DEFECT ON THE END OF THE STAPLE LINE WITH PERSISTENCE OF TISSUE BETWEEN THE JAWS. THE JAWS COULD NOT BE OPENED. TO RESOLVE THE ISSUE, ANOTHER STAPLER WAS USED.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 19082173 ↗
• MalfunctionApr 4, 2024Entrapment of Device; Mechanics Altered; Entrapment of Device; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN ENLARGED NEPHRECTOMY PROCEDURE, IN SECTION LIGATION OF THE RIGHT RENAL PEDICLE, THE HANDLE HAD A CRACKED SOUND AND WAS PHYSICALLY BROKEN AT THE MOMENT OF STAPLING. ADDITIONALLY, THERE WAS A CUTTING DEFECT ON THE END OF THE STAPLE LINE WITH PERSISTENCE OF TISSUE BETWEEN THE JAWS. THE JAWS COULD NOT BE OPENED. TO RESOLVE THE ISSUE, ANOTHER HANDLE AND RELOAD WERE USED.

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

  MAUDE report 19042006 ↗
• MalfunctionMar 20, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A SURGERY FOR AN AMPULLOMA, AT THE TIME OF SECTIONING THE PANCREAS, AFTER TWO USES OF THE STAPLER, THE HEALTHCARE PROFESSIONAL NOTICED THAT THE STAPLER NO LONGER STAPLED NOR CUT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE OPERATIVE TIME WAS EXTENDED BY 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946252 ↗
• MalfunctionJan 25, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HEPATECTOMY, WHILE STAPLING ON TISSUE, THE STAPLER WAS NOT ABLE TO FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. THE ISSUE OCCURRED ON TWO MORE RELOADS. A NEW RELOAD WAS THEN USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582033 ↗
• MalfunctionNov 14, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, WHEN THE SURGEON WAS TRYING TO STAPLE THE LUNG, THE STAPLES DID NOT COME OUT. THE GREEN BUTTON WAS UNABLE TO BE PRESSED AND THE HANDLE COULD NOT BE SQUEEZED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133086 ↗
• MalfunctionNov 3, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LIVER RESECTION, ON DETACHING THE LIVER PEDICLE, THE STAPLER WAS NOT ABLE TO FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. A NEW HANDLE WITH THE SAME RELOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THERE WAS RELOAD THICK TISSUE ISSUE. THE INSTRUMENT LOADED, CLAMPED, YET WOULD NOT CYCLE DUE TO SHEARED FIRING RACK TEETH DAMAGE. DUE TO THE SEVERITY OF THE BUCKLED KNIFE BAR ASSEMBLY, THE I BEAM WAS NOT ABLE TO BE FULLY RETRACTED.

  Patient problems: Insufficient Information

  MAUDE report 18066767 ↗
• MalfunctionOct 30, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ENDOSCOPIC TOTAL GASTRECTOMY, WHEN THE DUODENUM WAS DISSOCIATED, THE STAPLES DID NOT HAVE A GOOD B-SHAPED SHAPE. THE STAPLE LINE WAS ALSO CENTRALLY INCOMPLETE. TO RESOLVE THE ISSUE, THE SURGEON HAD TO HAND STITCH.

  Patient problems: Tissue Breakdown

  MAUDE report 18034330 ↗
• MalfunctionOct 5, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RADICAL SURGERY FOR LUNG CANCER, ON LOBECTOMY, ONE OF THE RELOAD WAS UNABLE TO OPEN THE JAWS. THE OTHER RELOAD FIRED ALL THE WAY, BUT HAD A POOR STAPLE FORMATION AND THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE SAME HANDLE WAS USED WITH THE NEW RELOAD OF THE SAME MODEL TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17883106 ↗
• MalfunctionOct 5, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER RESECTION PROCEDURE, WHILE RESECTING LIVER PEDICLE, THE STAPLER DID NOT FIRE. THE SURGEON COULD PRESS THE GREEN BUTTON, BUT COULD NOT SQUEEZE THE HANDLE. THE HANDLE AND RELOAD WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882030 ↗

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-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-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-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-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-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-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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

…and 57 more.