Endo GIA 030458Recalls & reported problems

Summary

The FDA's MAUDE database contains 948 adverse event reports that list this exact device (DI 10884523002898), received between Aug 8, 2016 and May 5, 2026 — classified as 1 death, 245 injuries, 701 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (434 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-1820-2018 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 948 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR RESECTION FOR A RECTOSIGMOID JUNCTION TUMOR, AT THE START OF THE PROCEDURE AND, WHEN THE USER ATTEMPTED TO BEGIN CUTTING TISSUE, THE INSTRUMENT DID NOT FIRE. IT WAS NOTED THAT THE STAPLER DID NOT CUT OR STAPLE. THE GREEN SAFETY BUTTON WAS ABLE TO BE PRESSED AND THE HANDLE WAS ABLE TO BE SQUEEZED. THE DEVICE WAS REPLACED WITH A NEW HANDLE AND RELOAD TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076736 ↗
• MalfunctionFeb 2, 2026Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT DURING A RIGHT LOBECTOMY INVOLVING THE RELOAD WITH A POWERED STAPLER, THE STAPLES WERE MISSING ON THE RIGHT SIDE OF THE CARTRIDGE. THIS LED TO BLEEDING, WHICH WAS TREATED WITH CLAMPS AND FURTHER RESECTION. THE ISSUE WAS RESOLVED BY RESECTING AND RE-STAPLING.

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

  MAUDE report 24240652 ↗
• MalfunctionJan 8, 2026Failure to Fire

  ACCORDING TO THE REPORTER DURING AN OBESITY PROCEDURE, THE SIX BLUE CARTRIDGES USED TOGETHER WITH A POWERED STAPLER DID NOT ADVANCE DURING FIRING EVEN THOUGH IT INITIALLY INDICATED LEVEL 1-2 AND SHOWED AN APPROPRIATE LEVEL. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. A NEW RELOAD OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000728 ↗
• MalfunctionJan 7, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OBESITY PROCEDURE, THE SIX BLUE CARTRIDGES USED TOGETHER WITH A POWERED STAPLER DID NOT ADVANCE DURING FIRING EVEN THOUGH IT INITIALLY INDICATED LEVEL 1-2 AND SHOWED AN APPROPRIATE LEVEL. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. A NEW RELOAD OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992192 ↗
• MalfunctionJan 7, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OBESITY PROCEDURE, THE SIX BLUE CARTRIDGES USED TOGETHER WITH A POWERED STAPLER DID NOT, ADVANCE DURING FIRING EVEN THOUGH IT INITIALLY. INDICATED LEVEL 1-2 AND SHOWED AN APPROPRIATE LEVEL. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. A NEW RELOAD OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992111 ↗
• MalfunctionJan 7, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OBESITY PROCEDURE, THE SIX BLUE CARTRIDGES USED TOGETHER WITH A POWERED STAPLER DID NOT ADVANCE DURING FIRING EVEN THOUGH IT INITIALLY INDICATED LEVEL 1-2 AND SHOWED AN APPROPRIATE LEVEL. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. A NEW RELOAD OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991638 ↗
• MalfunctionJan 7, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OBESITY PROCEDURE, THE SIX BLUE CARTRIDGES USED TOGETHER WITH A POWERED STAPLER DID NOT ADVANCE DURING FIRING EVEN THOUGH IT INITIALLY INDICATED LEVEL 1-2 AND SHOWED AN APPROPRIATE LEVEL. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. A NEW RELOAD OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991459 ↗
• MalfunctionJan 7, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OBESITY PROCEDURE, THE SIX BLUE CARTRIDGES USED TOGETHER WITH A POWERED STAPLER DID NOT ADVANCE DURING FIRING EVEN THOUGH IT INITIALLY INDICATED LEVEL 1-2 AND SHOWED AN APPROPRIATE LEVEL. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. A NEW RELOAD OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991398 ↗
• MalfunctionNov 27, 2025Misfire; Firing Problem; Misfire; Firing Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE FIRING STOP HALFWAY. THE GUN STARTED MAKING AN UNUSUAL GEAR-LIKE SOUND. THEREFORE, THE SURGEON OPENED AND REPLACED THE CARTRIDGE, ASSUMING IT MIGHT HAVE JAMMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669185 ↗
• MalfunctionNov 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LIVER RESECTION PROCEDURE, A STAPLER WAS USED TO TRANSECT THE LESION AND EXCESS TISSUE. DURING USE, A STAPLE FELL OFF. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565843 ↗
• MalfunctionOct 29, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, THE JAWS OF THE FIRST RELOAD BROKE AND DISENGAGED, BUT IT DID NOT FALL INTO THE CAVITY. THE JAWS OF THE SECOND AND THIRD RELOAD BROKE, BUT THE JAWS DID NOT DISENGAGE. A NEW DEVICE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23421024 ↗
• MalfunctionOct 29, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, THE JAWS OF THE FIRST RELOAD BROKE AND DISENGAGED, BUT IT DID NOT FALL INTO THE CAVITY. THE JAWS OF THE SECOND AND THIRD RELOAD BROKE, BUT THE JAWS DID NOT DISENGAGE. A NEW DEVICE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420997 ↗
• MalfunctionOct 29, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, THE JAWS OF THE FIRST RELOAD BROKE AND DISENGAGED, BUT IT DID NOT FALL INTO THE CAVITY. THE JAWS OF THE SECOND AND THIRD RELOAD BROKE, BUT THE JAWS DID NOT DISENGAGE. A NEW DEVICE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420931 ↗
• MalfunctionOct 23, 2025Entrapment of Device; Misfire; Entrapment of Device; Misfire

  IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED COLECTOMY, THE DEVICE EXPERIENCED MULTIPLE FIRING ISSUES, PARTIAL FIRE, AND THE DEVICE LOCKING ON TISSUE AND BEING UNABLE TO BE REMOVED. THE STAPLE LINE WAS REPORTED TO BE INCOMPLETE AT THE DISTAL END. THE PROCEDURE WAS EXTENDED BY 5-10 MINUTES DUE TO THE ISSUES. THE HANDLE AND CARTRIDGE WERE REPLACED WITH NEW ONES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375540 ↗
• MalfunctionOct 15, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE, THE INSTRUMENT DID NOT FIRE AFTER GRASPING THE TISSUE. A NEW BLUE RELOAD WAS REPLACED WITH THE SAME POWERED HANDLE AND ADAPTER AND THE CASE CONTINUED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288629 ↗
• MalfunctionOct 13, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER IN A SLEEVE GASTRECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT THE POWERED STAPLER DID NOT FIRE. THE SAME ISSUE HAPPENED TO A SECOND RELOAD. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR EIGHT TO TEN MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23275923 ↗
• MalfunctionOct 13, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER IN A SLEEVE GASTRECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT THE POWERED STAPLER DID NOT FIRE. THE SAME ISSUE HAPPENED TO A SECOND RELOAD. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR EIGHT TO TEN MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23275918 ↗
• MalfunctionOct 9, 2025Entrapment of Device; Misfire; Entrapment of Device; Misfire

  ACCORDING TO THE REPORTER, IN A PROCEDURE FOR OBESITY, THE POWERED STAPLER PARTIALLY FIRED. THE RELOAD GOT LOCKED AND CAPTURED TISSUE. THE INTERNAL TISSUES WERE DAMAGED. THE TISSUE WAS RESECTED AND RE-STAPLED TO FIX THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23252275 ↗
• MalfunctionJul 31, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT UPPER LOBE WEDGE RESECTION, THE JAW OF THE RELOAD TILTED AND WAS LOOSELY ATTACHED TO THE REST OF RELOAD. REPLACEMENT OF NEW INSTRUMENTS WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675904 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED THE SAFETY, EFFICACY, AND OUTCOMES OF ONE ANASTOMOSIS GASTRIC BYPASS (OAGB) AS A REVISIONAL PROCEDURE FOLLOWING FAILED VERTICAL BANDED GASTROPLASTY (VBG). SEVENTY-ONE PATIENTS UNDERWENT THE PROCEDURE BETWEEN FEBRUARY 2014 AND FEBRUARY 2020. A STAPLER CARTRIDGE (60MM, BLUE) WAS USED TO PERFORM THE ANASTOMOSIS BETWEEN THE GASTRIC POUCH AND SMALL BOWEL. THE STAPLING DEFECT WAS CLOSED WITH A COMPETITOR SUTURE. POSTOPERATIVE COMPLICATIONS INCLUDED ONE CASE (1.4%) OF ANASTOMOTIC STRICTURE, WHICH WAS MANAGED BY UPPER GI ENDOSCOPY AND BALLOON DILATATION, INDICATING A SERIOUS INJURY EVENT. OTHER COMPLICATIONS INCLUDED BLEEDING REQUIRING TRANSFUSION, LEAKAGE MANAGED BY ENDOSCOPY OR STENT, AND AN ABSCESS MANAGED BY DRAINAGE AND ANTIBIOTICS.

  Patient problems: Abscess; Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Stenosis; Unintended Radiation Exposure

  MAUDE report 22475611 ↗
• MalfunctionJun 2, 2025Mechanical Problem; Failure to Form Staple; Difficult to Open or Close; Mechanical Problem; Failure to Form Staple; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, AN ULTRASONIC SCALPEL WAS USED TO CUT OPEN THE ANTERIOR WALL OF THE STOMACH TO EXPOSE THE TUMOR. THE DOCTOR USED THE CUTTING STAPLER AND DISPOSABLE RELOAD FOR ENDOSCOPY IN A STANDARDIZED MANNER. THE RELOAD CLAMP WAS NOT CLOSED TIGHTLY, THE TISSUE SLID FORWARD WHEN FIRED, AND THE STAPLES WERE DEFORMED, RESULTING IN ANASTOMOSIS FAILURE AND TISSUE BLEEDING. LOCAL HEMOSTASIS WAS PERFORMED IMMEDIATELY, THE PATIENT'S VITAL SIGNS WERE MONITORED MORE CLOSELY DURING THE OPERATION, AND ANOTHER STAPLER WAS REPLACED TO CONTINUE THE OPERATION.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22128750 ↗
• MalfunctionMay 16, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A SINGLE-PORT THORACOSCOPIC LOBECTOMY (RIGHT UPPER LOBE) PLUS REGIONAL LYMPH NODE RESECTION, AFTER CUTTING THE LUNG TISSUE, THE STAPLE BURST OUT AND BLEED. A DIFFERENT TYPE OF RELOAD WAS THEN USED, BUT THE STAPLE BURST OUT AGAIN. THIS ISSUE CAUSED TISSUE DAMAGE. TO RESOLVE THE ISSUE, ANOTHER STAPLER WAS USED. HEMOSTASIS AT THE BLEEDING SITE AND MONITORING OF THE PATIENT'S VITAL SIGNS DURING THE SURGERY WERE STRENGTHENED. IT WAS NOTED THAT THE PROCEDURE TIME WAS EXTENDED.

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

  MAUDE report 22040710 ↗
• MalfunctionApr 22, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ENDO GIA R/OR 60 3.5MM, THERE WERE FIRING ISSUES WITH THE EGIA HANDLE. THE UNIT DID NOT CLOSE PROPERLY IN ORDER TO FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE CLAMPING MECHANISM WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883605 ↗
• MalfunctionMar 10, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN CUTTING AND CLOSING THE GASTRIC FUNDUS, THERE WAS INCOMPLETE STAPLE FORMATION LEADING TO BLEEDING. ADDITIONALLY, THE STAPLE LINE WAS INCOMPLETE. THE PATIENT HAD TISSUE DAMAGE DUE TO INCOMPLETE WOUND CLOSURE. SUTURE WAS USED TO REINFORCED THE WOUND AND THE STAPLE LINE.

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

  MAUDE report 21561023 ↗
• MalfunctionDec 11, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE INVOLVING THE RELOAD, THERE WERE ISSUES WITH THE STAPLE LINE BEING MALFORMED AND OPENING. THE DEVICE WAS REPLACED WITH A NEW RELOAD TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20905202 ↗

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 tr
• 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-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-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-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-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-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-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-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

…and 57 more.