GIA GIA8048LRecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10884523007275), received between Sep 6, 2017 and May 14, 2026 — classified as 12 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (31 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825, K221013); 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A RESECTION AND RIGHT ILEOCOLONIC ANASTOMOSIS ON OCCLUSION, WHEN USING THE SECOND REFILL, THE STAPLING LINE DID NOT GO ALL THE WAY TO THE END OF THE CLAMP. AN ADDITIONAL REFILL WAS GIVEN AFTER RINSING THE CLAMP AND AGAIN THE STAPLING LINE WAS INCOMPLETE. WITH A FOURTH REFILL, THE SURGEON WANTED TO CHANGE SIDES TO FINISH HIS CUT AND ANASTOMOSIS (FROM THE OPPOSITE END OF THE CUT) AND THE OPERATION THEN WENT WELL.

  Patient problems: Tissue Breakdown

  MAUDE report 25168222 ↗
• MalfunctionMay 14, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A RESECTION AND RIGHT ILEOCOLONIC ANASTOMOSIS ON OCCLUSION, WHEN USING THE SECOND REFILL, THE STAPLING LINE DID NOT GO ALL THE WAY TO THE END OF THE CLAMP. AN ADDITIONAL REFILL WAS GIVEN AFTER RINSING THE CLAMP AND AGAIN THE STAPLING LINE WAS INCOMPLETE. WITH A FOURTH REFILL, THE SURGEON WANTED TO CHANGE SIDES TO FINISH HIS CUT AND ANASTOMOSIS (FROM THE OPPOSITE END OF THE CUT) AND THE OPERATION THEN WENT WELL.

  Patient problems: Insufficient Information

  MAUDE report 25168187 ↗
• MalfunctionDec 16, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN OESOPHAGECTOMY, THE DEVICE DID NOT FIRE COMPLETELY TO THE DISTAL END WHILE RESECTING THE BODY PART OF THE STOMACH. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT.

  Patient problems: Tissue Breakdown

  MAUDE report 23823925 ↗
• MalfunctionDec 16, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE OPEN STAPLER DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818210 ↗
• MalfunctionJun 25, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC ESOPHAGECTOMY PROCEDURE, THE KNIFE DID NOT ADVANCE AND NO TISSUE WAS RESECTED AT ALL. ADDITIONALLY, NO STAPLE WAS DEPLOYED. THE DEVICE WAS REPLACED WITH A NEW CARTRIDGE OF THE SAME HANDLE, RESOLVING THE PROBLEM, AND THE PROCEDURE PROCEEDED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332592 ↗
• MalfunctionApr 2, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE PANCREATICODUODENECTOMY (PD), THE DEVICE, EXPERIENCED A FIRING ISSUE WHERE THE BLACK FIRING KNOB DID NOT ADVANCE, AND FIRING COULD NOT BE DONE. AS A RESULT, A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750900 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SETTING UP, THE STAPLE FELL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749595 ↗
• MalfunctionOct 11, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A PANCREATICODUODENECTOMY, WHILE IN THE STOMACH, THE DEVICE PARTIALLY FIRED. THE DEVICE WAS UNABLE TO COMPLETE THE FIRING TO THE DISTAL END. ADDITIONAL RESECTION WAS PERFORMED AND ADDITIONAL SUTURING WAS DONE WITH THE STAPLER TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20434115 ↗
• MalfunctionAug 5, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE COMPLETELY TO THE END. THE DEVICE PARTIALLY FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911716 ↗
• MalfunctionMay 27, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE FAILED TO FIRE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400828 ↗
• MalfunctionMay 21, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PANCREATICODUODENECTOMY, THE DUODENUM WAS RESECTED USING A STAPLER. AFTERWARDS, IN ORDER TO SHIFT TO GASTRECTOMY, THE DEFECTIVE LOADING UNIT WAS SET. THE SURGEON ATTEMPTED THE FIRE AND TRIED TO ADVANCE THE KNOB BUT COULD NOT ADVANCE, AND FIRING COULD NOT BE DONE. ANOTHER NEW CARTRIDGE WITH THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359910 ↗
• MalfunctionMay 20, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, IN A LAPAROTOMY GASTRECTOMY, DURING GASTRECTOMY, THE SECOND CARTRIDGE COULD ONLY BE FIRED HALFWAY. A THIRD CARTRIDGE WAS USED WITHOUT ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356319 ↗
• MalfunctionApr 18, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN INTESTINAL RESECTION PROCEDURE, WHEN ILEO-COLIC ANASTOMOSIS WAS PERFORMED, THE DEVICE WAS FIRED BUT IT DID NOT STAPLE THE TISSUE, BUT IT DID CUT IT, AND THERE WAS EXCESSIVE BLEEDING. IT WAS NOTED THAT THERE WAS TISSUE DAMAGE AT THE ANASTOMOSIS SITE. THE SURGICAL TIME WAS EXTENDED BY AN HOUR. A MANUAL SUTURING WAS DONE TO RESOLVE THE ISSUE.

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

  MAUDE report 19135515 ↗
• MalfunctionApr 11, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY, THE DEVICE PARTIALLY FIRED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM AS THEY HAD TO WAIT FOR A REPLACEMENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092197 ↗
• MalfunctionFeb 28, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY OPEN PROCEDURE, THE TWO RELOADS AT THE TIME OF FIRING IT DID NOT SEAL THE INTESTINE COMPLETELY. LEAVING THE STAPLE LINE OPEN. THE SURGEON RESECTED AND RE-STAPLED USING NEW RELOAD.

  Patient problems: Tissue Breakdown

  MAUDE report 18804410 ↗
• MalfunctionFeb 28, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY OPEN PROCEDURE, THE TWO RELOADS AT THE TIME OF FIRING IT DID NOT SEAL THE INTESTINE COMPLETELY. LEAVING THE STAPLE LINE OPEN. THE SURGEON RESECTED AND RE-STAPLED USING NEW RELOAD.

  Patient problems: Tissue Breakdown

  MAUDE report 18804385 ↗
• MalfunctionFeb 28, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING AN OPEN PANCREATICODUODENECTOMY PROCEDURE, AT THE TIME OF GASTRIC BODY RESECTION, THE DEVICE DID NOT FIRE. THE SURGEON REPLACED THE RELOAD WITH TWO GREEN RELOADS, BUT THE SAME ISSUE OCCURRED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. AFTERWARDS, THE RELOADS WERE CHECKED AND PRE-FIRED; THE DEVICE SLIGHTLY ADVANCED WHEN THE SURGEON FORCED IT IN OUTSIDE THE BODY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797692 ↗
• MalfunctionFeb 28, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING AN OPEN PANCREATICODUODENECTOMY PROCEDURE, THE FIRING DID NOT ADVANCE AT GASTRIC CORPUS RESECTION. THE SURGEON REPLACED THE BLUE RELOAD WITH TWO GREEN RELOADS, BUT THE SAME ISSUE OCCURRED, UNABLE TO PERFORM FIRING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. AFTERWARDS, THE RELOADS WERE CHECKED AND PRE-FIRED; THE DEVICE SLIGHTLY ADVANCED WHEN THE SURGEON FORCED IT IN OUTSIDE THE BODY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797679 ↗
• MalfunctionFeb 15, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING HYPEC COLORECTAL OPEN PROCEDURE, THE TWO CARTRIDGES DID NOT DEPLOY, DID NOT CUT TISSUE, THE BLACK PUSHER THUMB PIECE WAS UNABLE TO BE MOVED AT ALL. ANOTHER CARTRIDGE WAS USED TO RESOLVE THE ISSUE. IT WAS ALSO NOTED THAT INITIAL CARTRIDGE OF THE DEVICE WAS DEPLOYED PROPERLY THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18714083 ↗
• MalfunctionFeb 15, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING HYPEC COLORECTAL OPEN PROCEDURE, THE TWO CARTRIDGES DID NOT DEPLOY, DID NOT CUT TISSUE, THE BLACK PUSHER THUMB PIECE WAS UNABLE TO BE MOVED AT ALL. ANOTHER CARTRIDGE WAS USED TO RESOLVE THE ISSUE. IT WAS ALSO NOTED THAT INITIAL CARTRIDGE OF THE DEVICE WAS DEPLOYED PROPERLY THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18714062 ↗
• MalfunctionDec 12, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PANCREATICODUODENECTOMY, THE DUODENUM WAS RESECTED WITHOUT ANY PROBLEM USING THE PRELOADED BLUE CARTRIDGE FROM THE BEGINNING. AFTERWARDS, A NEW RELOAD WAS USED WITH THE SAME HANDLE AND ATTEMPTED TO RESECT THE PANCREAS, BUT THE KNOB DID NOT ADVANCE AND COULD NOT BE FIRED. A NEW CARTRIDGE WAS TAKEN OUT AND USED THE SAME OPEN STAPLER AND FIRING WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315460 ↗
• MalfunctionOct 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN AN OPEN BOWEL RESECTION, DURING COLON CLOSING AND RESECTION, THE DEVICE DID NOT FIRE. THE SURGEON CHANGED THE RELOAD AND THEN THE DEVICE FIRED. HOWEVER, THE NEXT RELOAD USED COULD NOT BE FIRED. 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 17971717 ↗
• MalfunctionSep 11, 2023Component or Accessory Incompatibility; Difficult to Open or Close; Component or Accessory Incompatibility; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BOWEL RESECTION, THE SURGEON COULD NOT PRESS THE GREEN BUTTON, BUT COULD SQUEEZE THE HANDLE; HENCE, FIRING COULD NOT BE DONE. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS DIFFICULTY LOADING THE OPEN STAPLER RELOAD INTO THE HANDLE. AFTER THE RELOAD WAS LOADED, THE JAWS OF THE DEVICE DID NOT CLOSE ON TISSUE. ANOTHER OPEN STAPLER RELOAD WAS USED TO RESOLVE THE ISSUE. ADDITIONALLY, THE THREE LINEAR RELOADS, WERE ALREADY FIRED BUT HAD AN UNKNOWN ISSUE. LASTLY, THE CLIPS FROM THE TWO CLIP APPLIERS DID NOT FORM PROPERLY. TO RESOLVE THE ISSUE, NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17718377 ↗
• MalfunctionAug 28, 2023Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTRECTOMY PROCEDURE, WHEN ON THE STOMACH, THE DEVICE GOT STUCK AFTER HALF FIRING, AND THERE WAS POOR STAPLE FORMATION. HENCE, TO RESOLVE THE ISSUE, THE SURGEON OVER SEWED WITH SUTURE AND USED ANOTHER RELOAD ON THE SAME TISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 17638485 ↗
• MalfunctionAug 28, 2023Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTRECTOMY PROCEDURE, WHEN ON THE STOMACH, THE DEVICE GOT STUCK AFTER HALF FIRING, AND THERE WAS POOR STAPLE FORMATION. HENCE, TO RESOLVE THE ISSUE, THE SURGEON OVER SEWED WITH SUTURE AND USED ANOTHER RELOAD ON THE SAME TISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 17632926 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825, K221013. 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-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-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-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-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-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-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-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-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT

…and 58 more.