GIA 030403Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884523003437), received between Sep 25, 2017 and Nov 27, 2024 — classified as 4 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN ATYPICAL WEDGE RESECTION, WHILE SETTING UP THE STAPLER PRIOR TO FIRING, THE RELOAD WAS PLACED ON THE HANDLE WITHOUT ISSUES, BUT IT WAS NOT POSSIBLE TO CLOSE THE RELOAD. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. THE SALES REPRESENTATIVE TRIED TO LOAD ANOTHER RELOAD TO THE HANDLE BUT THE SAME ISSUE OCCURRED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND INTERNAL COMPONENTS REVEALED SHEARED TEETH ON THE FIRING RACK DUE TO THICK TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796045 ↗
• MalfunctionOct 17, 2024Misfire; Noise, Audible; Misfire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, FIRING WAS ONLY POSSIBLE ABOUT HALF OF THE LOAD. SUDDENLY, THERE WAS A LOUD BANG AND THE DEVICE COULD NOT BE OPENED. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. ALSO, THE TISSUE WAS RESECTED AND RE-STAPLED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20476698 ↗
• MalfunctionJan 31, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE HANDLE WAS PHYSICALLY BROKEN AND NOT POSSIBLE TO RELOAD THE DEVICE. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18620017 ↗
• MalfunctionJul 24, 2023Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING INTERNAL SALES TRAINING, WHEN CYCLING THE RELOAD WITH A REUSED HANDLE, THE JAWS DID NOT CLOSE COMPLETELY. THERE WAS A GAP OF THREE TO FIVE MILLIMETERS. A DIFFERENT TYPE OF HANDLE WAS USED, BUT THE SAME ISSUE OCCURRED. TO RESOLVE THE ISSUE, A NEW RELOAD WITH A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17384405 ↗
• MalfunctionNov 7, 2022Break; Failure to Fire; Mechanics Altered; Break; Failure to Fire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PNEUMOTHORAX RELATED TO BULLOUS EMPHYSEMA AND HEMOTHORAX VIA VIDEO THORACOSCOPIC PROCEDURE, IN RESECTION OF APICAL DYSTROPHY, THE CLAMP BROKE WHEN THE STAPLE APPLICATION WAS NOT COMPLETE. THIS RESULTED IN INCOMPLETE STAPLING WITHOUT CUTTING THE PULMONARY PARENCHYMA. THE SURGEON HAD TO CUT WITH SCISSORS BETWEEN THE STAPLES (APPLIED BUT NOT CUT DUE TO THE CLAMP BREAKAGE) TO BE ABLE TO APPLY A NEW STAPLE WITHOUT IT BEING BOTHERED BY THE METAL OF THE STAPLES FROM THE PREVIOUS LINE. THE SECOND HANDLE OF THE SAME TYPE AND BATCH WAS USED BUT DID NOT MAKE THE SECOND STAPLE LINE. IT WAS NOTED THAT THE TISSUE WAS TOO THICK FOR THE PURPLE RELOAD. TO RESOLVE THE ISSUE, A THIRD HANDLE OF A DIFFERENT TYPE WAS USED. THE OPERATION TIME WAS EXTENDED FOR ABUT 15 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744011 ↗
• MalfunctionAug 26, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PNEUMOTHORAX PROCEDURE, THE STAPLER DID NOT WORKED, THE STAPLING COULD NOT BE COMPLETED. THE SECOND HANDLE DID NOT WORK AS WELL. IT WAS NOTED THAT THE TISSUE WAS TOO THICK FOR THE PURPLE RELOAD. TO RESOLVE THE ISSUE, A THIRD HANDLE OF A DIFFERENT TYPE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307549 ↗
• InjuryMay 20, 2022Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY, DEVICE WAS ABLE TO FIRE AND THE JAWS LOCKED ON THE TISSUE. THE KNIFE OF THE RELOAD WAS MANUALLY PULLED BACK TO OPEN THE JAWS. THE SURGICAL PROCEDURE WAS DELAYED MORE THAN 30 MINUTES DUE TO THE REPORTED ISSUE. THE PROCEDURE WAS CONVERTED TO OPEN TO RESOLVE THE CONCERN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14457402 ↗
• MalfunctionMar 23, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTRECTOMY PROCEDURE, WHILE TRANSECTING THE GASTRIC TISSUE, THE DEVICE DID NOT FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. A NEW HANDLE WAS USED WITH THE SAME RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869981 ↗
• MalfunctionNov 24, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER DURING AN OPEN METASTASECTOMY PROCEDURE, WHEN STAPLING, THE STAPLER GOT STUCK ON THE LUNG. THE SURGEON WAS THEN ABLE TO RELEASE THE DEVICE FROM THE LUNG. TO RESOLVE THE ISSUE, ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868656 ↗
• MalfunctionNov 24, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER DURING AN OPEN METASTASECTOMY PROCEDURE, WHEN STAPLING, THE STAPLER GOT STUCK ON THE LUNG. THE SURGEON WAS THEN ABLE TO RELEASE THE DEVICE FROM THE LUNG. TO RESOLVE THE ISSUE, ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868655 ↗
• MalfunctionOct 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE RELOAD DETACHED FROM THE HANDLE AND FELL INTO PATIENT'S CAVITY DURING AN OPEN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 12637262 ↗
• MalfunctionJun 7, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN THORACIC PROCEDURE, THE SURGEON COULD NOT FIRE THE STAPLER. ANOTHER HANDLE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947199 ↗
• MalfunctionSep 28, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THORACIC PROCEDURE, THE SURGEON WAS NOT ABLE TO PRESS THE GREEN BUTTON, COULD NOT SQUEEZE THE HANDLE AND THE DEVICE DID NOT FIRE. SCRUB NURSE GAVE SURGEON A SECOND HANDLE TO COMPLETE THE CASE. IT WAS NOTED THAT THE ISSUE DID NOT IMPACT PATIENT AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10597716 ↗
• MalfunctionJul 23, 2020Break; Failure to Fire; Break; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN RIGHT UPPER PULMONARY LOBECTOMY BY LATERAL POSTERIOR THORACOTOMY, THE SURGEON WAS UNABLE TO STAPLE BECAUSE THE HANDLE WAS BLOCKED. THE GREEN BUTTON WAS PRESSED BUT THE HANDLE COULD NOT BE SQUEEZED. ANOTHER STAPLER WAS TAKEN OUT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10316951 ↗
• MalfunctionJan 23, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A RIGHT COLON HEMICOLECTOMY PROCEDURE, THERE WAS AN INCOMPLETE STAPLE LINE ON THE CENTRAL AREA AND POOR STAPLE FORMATION USING THE FIRST RELOAD AND HANDLE FOR TISSUE ANASTOMOSIS. ANOTHER RELOAD WAS USED TO REPAIR THE STAPLE LINE BUT THE DEVICE COULD NOT BE FIRED. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. A THIRD RELOAD WAS USED TOGETHER WITH A NEW HANDLE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9621408 ↗
• MalfunctionJan 7, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LEFT LOWER LOBE RESECTION, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS NOT ABLE TO SQUEEZE THE HANDLE AND THE DEVICE WAS NOT ABLE TO FIRE. SURGEON USED COMPETITOR'S DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557885 ↗
• MalfunctionDec 30, 2019Entrapment of Device; Failure to Fire; Human-Device Interface Problem; Entrapment of Device; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WOULD NOT RELEASE STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530537 ↗
• MalfunctionOct 8, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE TRANSECTING LUNG TISSUE DURING AN OPEN LOBECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND WAS ABLE TO SQUEEZE THE HANDLE, BUT THE HANDLE DID NOT FIRE. ANOTHER HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9167920 ↗
• MalfunctionSep 19, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, IT WAS IMPOSSIBLE TO FIRE THE STAPLE AND THE CLAMP WAS BLOCKED.

  Patient problems: Insufficient Information; No Information

  MAUDE report 9096159 ↗
• MalfunctionAug 28, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OCCLUSION OR BLOCKAGE PROCEDURE, THE DEVICE DID NOT FIRE. ANOTHER HANDLE WAS USED WITH THE SAME RELOAD AND IT WORKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8942767 ↗
• MalfunctionAug 13, 2019Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, DURING THORACIC PROCEDURE, AFTER RELOADING THE HANDLE FOR THE SECOND FIRING, THE RELOAD WOULD NOT CLOSE. THE SAME RELOAD AND ANOTHER HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8891321 ↗
• MalfunctionJul 30, 2019Entrapment of Device; Human-Device Interface Problem; Entrapment of Device; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY PROCEDURE, DURING THE SECOND FIRING, THE STAPLER GOT STUCK AND LOCK ON TISSUE AND CANNOT BE UNLOADED. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842551 ↗
• MalfunctionJul 24, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN COLON CANCER RADICAL SURGERY PROCEDURE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE, HENCE THE DEVICE DID NOT FIRE. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822539 ↗
• MalfunctionJul 1, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A HAND ASSISTED LAPAROSCOPIC COLECTOMY, THAT A RELOAD WAS USED AND WAS NOTED THAT THEY ARE NOT SURE WHETHER IT'S THE PURPLE OR TAN RELOAD THAT WOULD NOT CLOSE OR FIRE. A NEW HANDLE OF THE SAME MODEL WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748057 ↗
• MalfunctionJun 12, 2019Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATICODUODENECTOMY, THE RELOAD COULD NOT BE OPENED. AFTER THE STAPLE WAS LOADED, WHEN THE DEVICE WAS TESTED, IT CANNOT BE OPENED AGAIN AFTER CLOSING THE STAPLE CARTRIDGE. THE STAPLER WAS NOT ABLE TO FIRE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. THEY REPLACED THE DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8693137 ↗

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-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-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-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-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-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-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-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-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-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-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT

…and 58 more.