Endo GIA EGIA30CTAVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 351 adverse event reports that list this exact device (DI 10884523003147), received between Jan 22, 2017 and Feb 3, 2026 — classified as 1 death, 33 injuries, 317 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (192 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 351 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A SINGLE-PORT THORACOSCOPIC LOBECTOMY, THE RELOAD WAS USED TO DETACH THE ARTERIES WHEN POOR STAPLE FORMATION WAS OBSERVED, AS THE STAPLE WAS NOT FULLY FORMED, AND AN INCOMPLETE STAPLE LINE WAS NOTED AT THE PROXIMAL LOCATION. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW RELOAD.

  Patient problems: Tissue Breakdown

  MAUDE report 24245429 ↗
• MalfunctionJan 28, 2026Failure to Fire

  IT WAS REPORTED THAT DURING VIDEO-ASSISTED THORACIC SURGERY (VATS), THE INSTRUMENT DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. THE RELOAD WAS REPLACED WITH THE SAME PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205988 ↗
• MalfunctionJan 2, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A THORACOSCOPIC RIGHT UPPER LOBECTOMY, THE THE JAWS OF THE RELOAD DID NOT CLOSE AT ALL DURING THE HANDLE TEST. A NEW HANDLE AND RELOAD WERE USED 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 23944099 ↗
• MalfunctionDec 30, 2025Unintended System Motion; Unintended System Motion

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING FIRING, THREE CURVED TIP RELOADS HAD UNCONTROLLED ARTICULATION. THE RELOADS WERE UNSTABLE OR SHAKING DURING FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920253 ↗
• MalfunctionDec 30, 2025Unintended System Motion; Unintended System Motion

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING FIRING, THREE CURVED TIP RELOADS HAD UNCONTROLLED ARTICULATION. THE RELOADS WERE UNSTABLE OR SHAKING DURING FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920247 ↗
• MalfunctionDec 30, 2025Unintended System Motion; Unintended System Motion

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING FIRING, THREE CURVED TIP RELOADS WERE UNSTABLE OR SHAKING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920241 ↗
• MalfunctionNov 27, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL SURGERY FOR LUNG CANCER, THE TWO RELOADS WERE APPLIED TO THE BRONCHUS FOR DETACHMENT; THERE WERE ALLEGATIONS OF POOR STAPLE FORMATION, WITH THE DEVICE STAPLING ONLY PARTIALLY, AND AN INCOMPLETE STAPLE LINE AT THE PROXIMAL LOCATION, WHICH LED TO TISSUE BLEEDING. HAND SUTURING WAS REQUIRED TO FIX THE INCOMPLETE STAPLE LINE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW ONE TO COMPLETE THE SURGERY.

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

  MAUDE report 23666233 ↗
• MalfunctionNov 27, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL SURGERY FOR LUNG CANCER, THE TWO RELOADS WERE APPLIED TO THE BRONCHUS FOR DETACHMENT; THERE WERE ALLEGATIONS OF POOR STAPLE FORMATION, WITH THE DEVICE STAPLING ONLY PARTIALLY, AND AN INCOMPLETE STAPLE LINE AT THE PROXIMAL LOCATION, WHICH LED TO TISSUE BLEEDING. HAND SUTURING WAS REQUIRED TO FIX THE INCOMPLETE STAPLE LINE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW ONE TO COMPLETE THE SURGERY.

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

  MAUDE report 23666224 ↗
• MalfunctionNov 27, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCEDURE, AN INCOMPLETE STAPLE LINE WAS IDENTIFIED.

  Patient problems: Tissue Breakdown

  MAUDE report 23666202 ↗
• MalfunctionNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER FIRING THE INTO A VESSEL, THERE WAS BLEEDING OR OOZING AT THE STAPLE LINE. THE BLEEDING WAS CONTROLLED WITH A HEMOSTAT PATCH AND CLIPS AND THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 10 MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23566908 ↗
• MalfunctionNov 14, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE MANUAL STAPLER AND RELOAD DID NOT FIRE AND BECAME STUCK. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. THE HANDLE AND RELOADS WERE REPLACED 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 23563373 ↗
• MalfunctionNov 4, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE LEFT UPPER LOBECTOMY, WHEN DETACHING THE PULMONARY VEIN, THE STAPLER PARTIALLY FIRED AND THE HANDLE HAD IDLE MOTION WHEN SQUEEZED. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468385 ↗
• InjuryOct 20, 2025Entrapment of Device; Retraction Problem; Entrapment of Device; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACIC LOBECTOMY, WHILE DETACHING THE PULMONARY LOBAR ARTERY, THE RELOAD FIRED NORMALLY, BUT THE BLACK RETRACTION KNOB ON THE HANDLE WOULD NOT PULL DESPITE NUMEROUS ATTEMPTS. THE VESSEL BEING DETACHED AT THE TIME WAS A PULMONARY ARTERY. ONCE BLEEDING OCCURRED, THORACOTOMY WAS NECESSARY AND THERE WAS AT LEAST 2000 MILLILITERS (ML) OF BLOOD LOSS. FURTHERMORE, THERE WAS VERY LITTLE TISSUE SURROUNDING THE VESSEL, LEAVING NO ROOM FOR FURTHER FREEING AND DETACHMENT. AFTER A LONG PERIOD OF EFFORT, USING SURGICAL FORCEPS TO REMOVE THE TISSUE CLOSE TO THE CLAMP LITTLE BY LITTLE AND MOBILIZING THE SURROUNDING TISSUE, THE ALREADY CLOSED VESSEL WAS FINALLY SEPARATED FROM THE RELOAD SLOWLY WITHOUT BLEEDING AT THE PROXIMAL END. THE PROCEDURE WAS EXTENDED FOR 30 MINUTES OR MORE DUE TO THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 23344114 ↗
• MalfunctionOct 20, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL SURGERY, DURING DETACHMENT OF THE BRONCHUS, THE STAPLES WERE PARTIALLY NOT FORMED, AND THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE SAME ISSUE OCCURRED ON FIVE RELOADS. THE SURGEON MANUALLY SUTURED THE TISSUE WITH A NEW RELOAD TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 23334219 ↗
• MalfunctionOct 20, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL SURGERY, DURING DETACHMENT OF THE BRONCHUS, THE STAPLES WERE PARTIALLY NOT FORMED, AND THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE SAME ISSUE OCCURRED ON FIVE RELOADS. THE SURGEON MANUALLY SUTURED THE TISSUE WITH A NEW RELOAD TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 23334216 ↗
• MalfunctionOct 20, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL SURGERY, DURING DETACHMENT OF THE BRONCHUS, THE STAPLES WERE PARTIALLY NOT FORMED, AND THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE SAME ISSUE OCCURRED ON FIVE RELOADS. THE SURGEON MANUALLY SUTURED THE TISSUE WITH A NEW RELOAD TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 23334203 ↗
• MalfunctionOct 20, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL SURGERY, DURING DETACHMENT OF THE BRONCHUS, THE STAPLES WERE PARTIALLY NOT FORMED, AND THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE SAME ISSUE OCCURRED ON FIVE RELOADS. THE SURGEON MANUALLY SUTURED THE TISSUE WITH A NEW RELOAD TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 23334199 ↗
• MalfunctionOct 17, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL SURGERY, DURING DETACHMENT OF THE BRONCHUS, THE STAPLES WERE PARTIALLY NOT FORMED, AND THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE SAME ISSUE OCCURRED ON FIVE RELOADS. THE SURGEON MANUALLY SUTURED THE TISSUE WITH A NEW RELOAD TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 23324978 ↗
• InjurySep 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) RIGHT LOWER LOBE LOBECTOMY, WHILE PERFORMING LIGATION OF THE PULMONARY ARTERY, IMMEDIATE BLEEDING OCCURRED FOLLOWING STAPLER FIRING. THE PROCEDURE WAS CONVERTED FROM LAPAROSCOPIC TO OPEN THORACOTOMY TO ACHIEVE HEMOSTASIS. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 1500 MILLILITERS (ML). UPON INSPECTION AFTER VASCULAR SUTURING, THE STAPLE LINE AT THE DISTAL PULMONARY ARTERY (SPECIMEN SIDE) WAS COMPLETE; HOWEVER, NO STAPLE LINE WAS OBSERVED ON THE PROXIMAL PULMONARY ARTERY (PATIENT SIDE), AND A SHARP TRANSECTION WAS IDENTIFIED. IT WAS NOTED THAT THE STAPLE LINE DID NOT HOLD OR OPENED UP, AND SUTURING WAS REQUIRED AS A REPLACEMENT FOR THE STAPLE LINE. THE PATIENT REMAINED HOSPITALIZED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); Tissue Breakdown

  MAUDE report 23045898 ↗
• MalfunctionAug 25, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A UNIPORTAL THORACOSCOPIC LOBECTOMY, THE STAPLER EXHIBITED POOR DISTAL STAPLE FORMATION AND INCOMPLETE DISTAL STAPLE LINES FOR ALL THREE RELOADS. REINFORCED SUTURE WITH THREAD WAS REQUIRED TO FIX THE INCOMPLETE STAPLE LINES.

  Patient problems: Tissue Breakdown

  MAUDE report 22888930 ↗
• MalfunctionAug 25, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A UNIPORTAL THORACOSCOPIC LOBECTOMY, THE STAPLER EXHIBITED POOR DISTAL STAPLE FORMATION AND INCOMPLETE DISTAL STAPLE LINES FOR ALL THREE RELOADS. REINFORCED SUTURE WITH THREAD WAS REQUIRED TO FIX THE INCOMPLETE STAPLE LINES.

  Patient problems: Tissue Breakdown

  MAUDE report 22888870 ↗
• MalfunctionAug 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THORACOSCOPIC LOBECTOMY (LUNG LOBE RESECTION), THE HANDLE AND RELOAD COULD NOT BE LOADED PROPERLY, AND THE CONNECTION PORT OF ANOTHER RELOAD COMPONENT WAS FOUND BROKEN UPON UNPACKING. THE DEVICES WERE INTENDED FOR USE DURING THE DETACHMENT OF THE INTERLOBAR FISSURE AND LEFT SUPERIOR LOBE VEIN. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICES WITH ANOTHER MANUFACTURER'S PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861492 ↗
• MalfunctionAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, STAPLE LINE BLEEDING WAS NOTED ON THE FOUR RELOADS AFTER FIRING. SUTURING AS A STAPLE LINE REINFORCEMENT WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22739974 ↗
• MalfunctionAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, STAPLE LINE BLEEDING WAS NOTED ON THE FOUR RELOADS AFTER FIRING. SUTURING AS A STAPLE LINE REINFORCEMENT WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22739830 ↗
• MalfunctionJul 29, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC DISTAL PANCREATECTOMY, WHEN DETACHING THE BLOOD VESSEL, THE STAPLER DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. ANOTHER MANUFACTURER'S DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22654600 ↗

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 tra
• 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-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-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-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-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-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-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-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-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-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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

…and 58 more.