Endo GIA 030455Recalls & reported problems

Summary

The FDA's MAUDE database contains 324 adverse event reports that list this exact device (DI 10884523002867), received between Jul 11, 2017 and May 6, 2026 — classified as 1 death, 74 injuries, 249 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (137 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 26, 2018Terminated

   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-1818-2018 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 324 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE STAPLER DID NOT FIRE. THE RELOAD AND THE HANDLE WERE REPLACED TO RESOLVE THE FIRING ISSUE. THE PATIENT WAS REPORTED TO HAVE NO CONSEQUENCES OR IMPACT, WITH NO SYMPTOMS, AND WAS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25098384 ↗
• MalfunctionMar 30, 2026Mechanics Altered

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE MANUAL STAPLER CUT THE TISSUE BUT NO STAPLES WERE DEPLOYED. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24735469 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, THERE WAS NO POSITIVE LEAK TEST. POSTOPERATIVELY, AT THE LAST RELOAD, THE PATIENT HAD STAPLE LINE GASTRIC LEAKAGE AT THE UPPER PART OF THE STOMACH, NEAR THE ESOPHAGUS. THE PATIENT ALSO EXPERIENCED EXTENDED HOSPITALIZATION OF AT LEAST TWO WEEKS AND REQUIRED REOPERATION WITH PROSTHESIS IMPLEMENTATION.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 22532550 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, THERE WAS NO POSITIVE LEAK TEST. POSTOPERATIVELY, THE PATIENT HAD STAPLE LINE GASTRIC LEAKAGE. THE PATIENT ALSO EXPERIENCED EXTENDED HOSPITALIZATION OF AT LEAST TWO WEEKS AND REQUIRED REOPERATION WITH PROSTHESIS IMPLEMENTATION.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 22526844 ↗
• MalfunctionMay 12, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC LEFT UPPER LOBECTOMY, THE RELOAD COULD NOT BE FIRED WHEN THE UPPER LOBE VEIN WAS SEVERED, AND THE OPERATION WAS COMPLETED AFTER REPLACING THE RELOAD. WHEN THE INTERLOBAR FISSURE WAS DETACHED, USING ANOTHER RELOAD, THE STAPLES DID NOT HAVE A GOOD B-SHAPED FORMATION AND BLEEDING OCCURRED. FINALLY, THE LUNG PARENCHYMA WAS SUTURED MANUALLY UNDER LAPAROSCOPY.

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

  MAUDE report 22000396 ↗
• MalfunctionMar 13, 2025Misfire; Device Displays Incorrect Message; Misfire; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A BARIATRIC SURGERY, WHEN THE FUNDUS WAS CLAMPED WITH THE RELOAD, AFTER THE FIRING SEQUENCE WAS INITIATED, THE POWERED HANDLE SHOWED AN EXCESSIVE LOAD DETECTION. THE DEVICE DID NOT FIRE COMPLETELY. ANOTHER 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 21596424 ↗
• MalfunctionDec 10, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY PROCEDURE, THE SURGEON HEARD ABNORMAL SOUNDS WHILE USING THE DEVICE ON THE TISSUE THAT WAS TOO THICK, AND THE CUTTING WAS LABORIOUS. THE STAPLE AND THE ANASTOMOSIS WERE NOT CLOSED. TO RESOLVE THE ISSUE, ANOTHER HANDLE AND RELOAD WERE USED.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 20896338 ↗
• MalfunctionOct 30, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING RADICAL RESECTION OF RECTAL CANCER, THE RELOAD MALFUNCTIONED, CAUSING THE CUT INTESTINAL TUBE TO NOT BE ANASTOMOSED. THE RELOAD WAS REPLACED, THE ANASTOMOSIS WAS SMOOTH, AND THE OPERATION WAS SUCCESSFULLY COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 20566796 ↗
• MalfunctionOct 1, 2024Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY, AFTER DETACHING THE LEFT UPPER LOBE TISSUE, THE STAPLE COULD NOT BE DIS ASSEMBLED. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S EVALUATION OF THE DEVICE FOUND THAT THE CLAMPING MECHANISM WAS DEFORMED WHICH IS INDICATIVE OF BEING APPLIED TO TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346640 ↗
• MalfunctionSep 18, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE COLORECTAL RESECTION, WHEN APPLIED ON THE RECTUM, THE STAPLER AND THE TWO RELOADS COULD NOT BE FIRED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246245 ↗
• MalfunctionMay 8, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC BOWEL CANCER SURGERY, WHEN DETACHING THE RECTUM, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274794 ↗
• MalfunctionMay 6, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BOWEL RESECTION, WHILE DETACHING THE SIGMOID COLON, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. HOWEVER, THE HANDLE COULD NOT BE SQUEEZED. THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, ONLY THE RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248853 ↗
• MalfunctionApr 18, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC WEDGE GASTRECTOMY PROCEDURE FOR A PATIENT WITH GASTROINTESTINAL STROMAL TUMOR (GIST), THE SURGEON ACTIVATED THE 45-MILLIMETER (MM) DEVICE, WHICH FIRED AND CUT; HOWEVER, THE STAPLES DID NOT CURL AND CLOSE THE TISSUE. THE STAPLES WERE SEEN WITH STRAIGHT ENDS AND AN OPEN GASTRIC MUCOSA. THIS WAS OVER THE FULL LENGTH OF THE STAPLER. THE SURGEON THEN USED TWO PURPLE 60-MM RELOADS AND OVERSEWED THE AREA.

  Patient problems: Tissue Breakdown

  MAUDE report 19135019 ↗
• MalfunctionApr 18, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AFTER FIRING, THE SURGEON WAS UNABLE TO OPEN THE JAWS, IT LOCKED ON THE TISSUE. THIS ISSUE OCCURRED ON THREE HANDLES WITH NINE RELOADS. TO RESOLVE THE ISSUE, ANOTHER HANDLE WITH AN UNKNOWN LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133824 ↗
• MalfunctionApr 18, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AFTER FIRING, THE SURGEON WAS UNABLE TO OPEN THE JAWS, IT LOCKED ON THE TISSUE. THIS ISSUE OCCURRED ON THREE HANDLES WITH NINE RELOADS. TO RESOLVE THE ISSUE, ANOTHER HANDLE WITH AN UNKNOWN LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133818 ↗
• MalfunctionMar 13, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC SEGMENTECTOMY, WHEN FIRING, AFTER HOLDING AND PULLING THE HANDLE, THE BLACK RETURN BUTTON WAS PUSHED A LITTLE AND THEN THE BUTTON WAS STAGNANT AND COULD NOT BE PUSHED FORWARD NORMALLY. AFTER REPLACING WITH THE SAME TYPE OF RELOAD, THE STAPLER COULD BE USED NORMALLY AND FIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899855 ↗
• MalfunctionMar 7, 2024Break; Misfire; Break; Misfire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC LOBECTOMY, WHEN DETACHING THE LUNG LOBE AND FIRING THE RELOAD, THE HANDLE BODY WAS DAMAGED AND COULD NOT CONTINUE FIRING. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859290 ↗
• MalfunctionFeb 22, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE , AT THE BEGINNING OF SURGERY, THE DEVICE FIRED, BUT THE RELOAD DID NOT STAPLE. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 18763997 ↗
• MalfunctionFeb 7, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LEFT LOWER LUNG WEDGE RESECTION WITH VATS (VIDEO-ASSISTED THORACOSCOPIC SURGERY), WHILE INITIATING THE FIRING IN THE FINAL PORTION, THE SURGEON FIRED THE FIRST RELOAD, BUT DUE TO THE LCD SCREEN DISPLAYED AN EXCLAMATION MARK WARNING ABOUT EXCESSIVE THICKNESS, THE SURGEON DECIDED TO RETRACT THE BLADE, STEP BACK AND SWITCH TO ANOTHER RELOAD. HOWEVER, THE RECENTLY FIRED STAPLES DID NOT FORM A 'B' SHAPE. THE SURGEON REMOVED THE UNFORMED STAPLES AND USED A NEW RELOAD WITH THE SAME POWERED DEVICES TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 18664664 ↗
• MalfunctionFeb 7, 2024Misfire; Device Displays Incorrect Message; Misfire; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A LEFT LOWER LUNG WEDGE RESECTION WITH VATS (VIDEO-ASSISTED THORACOSCOPIC SURGERY), WHILE INITIATING THE FIRING IN THE FINAL PORTION, THE SURGEON FIRED THE FIRST RELOAD, BUT DUE TO THE LCD SCREEN DISPLAYED AN EXCLAMATION MARK WARNING ABOUT EXCESSIVE THICKNESS, THE SURGEON DECIDED TO RETRACT THE BLADE, STEP BACK AND SWITCH TO ANOTHER RELOAD. HOWEVER, THE RECENTLY FIRED STAPLES DID NOT FORM A 'B' SHAPE. THE SURGEON REMOVED THE UNFORMED STAPLES AND USED A NEW RELOAD TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18664600 ↗
• MalfunctionFeb 5, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, WHEN READY TO START THE FIRING PROCESS, THE GREEN BUTTON WAS PRESSED, THERE WAS NO WARNING AND EVERYTHING WAS NORMAL, BUT IMMEDIATELY AFTER THE FIRING STARTED AND FIRED 3-4 STAPLES, THE FIRING STOPPED AND DID NOT CONTINUE. A DIFFERENT RELOAD WAS USED TO COMPLETE THE PROCESS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18642947 ↗
• MalfunctionFeb 2, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY, AFTER THE PRODUCT EXTENDED INTO TROCAR AND HELD THE TISSUE, THE SURGEON COULD PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE, BUT IT WAS FOUND THAT THE STAPLER COULD NOT BE FIRED AT ALL AFTER INSTALLATION, AND THE BLACK HOMING BUTTON COULD NOT MOVE FORWARD. THE RELOAD WAS REPLACED WITH THE SAME TYPE AND SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632185 ↗
• MalfunctionJan 18, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE APPENDECTOMY, THE STAPLER DID NOT FIRE. THE GREEN BUTTON WAS PRESSED, BUT THE HANDLE JAMMED. THE RELOAD WAS REPLACED, AND THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536706 ↗
• MalfunctionJan 9, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE USER WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THE ISSUE OCCURRED IN ONE HANDLE AND THREE RELOADS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481056 ↗
• MalfunctionJan 4, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A SINGLE OPERATING-HOLE THORACOSCOPIC LUNG WEDGE RESECTION, IN DETACHING LUNG TISSUE, THE STAPLE BURST OUT WHEN THE FIRST RELOAD WAS FIRED. A SECOND RELOAD WAS THEN USED; THE GREEN BUTTON WAS PRESSED AND THE HANDLE COULD BE SQUEEZED, BUT THE DEVICE STILL FAILED TO FIRE. TO RESOLVE THE ISSUE, ANOTHER HANDLE WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 18445291 ↗

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 tr
• 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-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-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-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-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-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-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-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT

…and 57 more.