GIA GIA10048SRecalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10884521033634), received between Aug 16, 2016 and Nov 8, 2025 — classified as 18 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (41 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO OPEN STAPLERS WERE ASSOCIATED WITH STAPLE LINE BLEEDING AFTER FIRING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23505357 ↗
• MalfunctionNov 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO OPEN STAPLERS WERE ASSOCIATED WITH STAPLE LINE BLEEDING AFTER FIRING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23505356 ↗
• MalfunctionSep 9, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE IN THE PROCESS OF OPERATING THE STAPLER, THE SIGNAL WAS CUT OFF. THE DEVICE WAS THEN REPLACED WITH A NEW PRODUCT TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23003606 ↗
• MalfunctionMay 8, 2025Misfire; No Apparent Adverse Event; Misfire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WERE FIRING ISSUES WITH THE DEVICE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985498 ↗
• MalfunctionApr 30, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A COLECTOMY, THERE WERE FIRING ISSUES DURING A PROCEDURE INVOLVING THE TWO OPEN STAPLER. THE DEVICES EXPERIENCED PARTIAL FIRING, NOT COMPLETING TO THE DISTAL END. THE DEVICES 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 21933475 ↗
• MalfunctionOct 11, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A SMALL BOWEL RESECTION, THE SURGEON PUSHED THE BLACK FIRING KNOB ONLY 0.5 CM THEN THE STAPLER GOT STUCK AND THE SURGEON COULD NOT MOVE IT EITHER WAY. THE SURGEON THEN DISSECTED THE STUCK TISSUE AND ANOTHER OF THE SAME STAPLER WAS USED AND WITH THIS NEW STAPLER THE BLACK FIRING KNOB COULD NOT BE PUSHED AT ALL. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE. ANOTHER DEVICE FROM A COMPETITOR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20434738 ↗
• MalfunctionOct 11, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SMALL BOWEL RESECTION, THE SURGEON PUSHED THE BLACK FIRING KNOB ONLY 0.5 CM THEN THE STAPLER GOT STUCK AND THE SURGEON COULD NOT MOVE IT EITHER WAY. THE SURGEON THEN DISSECTED THE STUCK TISSUE AND ANOTHER OF THE SAME STAPLER WAS USED AND WITH THIS NEW STAPLER THE BLACK FIRING KNOB COULD NOT BE PUSHED AT ALL. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE. ANOTHER DEVICE FROM A COMPETITOR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 20434736 ↗
• MalfunctionAug 9, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN END-TO-END ANASTOMOSIS OF THE INTESTINE AFTER TUMOR RESECTION FOR COLORECTAL CANCER, FOR RECONS TRUCTION OF THE ENTIRE DIGESTIVE TRACT, THE SURGEON PERFORMED THE SURGERY NORMALLY, AND FOUND THAT AFTER FIRING, THE STAPLES WERE NOT COMPLETELY CLOSED, AND THE MUSCLE LAYER WAS EXPOSED. THE SURGEON REINFORCED IT MANUALLY AND SUTURED IT AGAIN TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 19950496 ↗
• MalfunctionJun 28, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, AFTER THE 1ST FIRING, THE STAPLER IS NOT ABLE TO FIRE THE 2ND RELOAD. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635749 ↗
• MalfunctionJun 28, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, AFTER THE 1ST FIRING, THE STAPLER IS NOT ABLE TO FIRE THE 2ND RELOAD. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635239 ↗
• MalfunctionJun 6, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, AFTER THE 1ST FIRING, THE STAPLER IS NOT ABLE TO FIRE THE 2ND RELOAD. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477731 ↗
• MalfunctionJun 6, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, AFTER THE 1ST FIRING, THE STAPLER WAS NOT ABLE TO FIRE THE 2ND RELOAD. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477709 ↗
• MalfunctionMay 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, AFTER THE 1ST FIRING, THE STAPLER WAS NOT ABLE TO FIRE THE 2ND RELOAD. THIS OCCURRED ON ALL THREE STAPLERS. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393459 ↗
• MalfunctionMay 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, AFTER THE 1ST FIRING, THE STAPLER WAS NOT ABLE TO FIRE THE 2ND RELOAD. THIS OCCURRED ON ALL THREE STAPLERS. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393441 ↗
• MalfunctionMay 24, 2024Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, AFTER THE 1ST FIRING, THE STAPLER WAS NOT ABLE TO FIRE THE 2ND RELOAD. THIS OCCURRED ON ALL THREE STAPLERS. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393422 ↗
• MalfunctionMar 20, 2024Failure to Fire; Fail-Safe Problem; Failure to Fire; Fail-Safe Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PANCREATIC HEAD AND DUODENAL RESECTION, AT THE TIME OF GASTRIC RESECTION, THE FIRING KNOB COULD NOT BE PUSHED FORWARD; AND WHEN THE HANDLE WAS OPENED, THE SAFETY COVER STARTED TO RISE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946190 ↗
• MalfunctionFeb 16, 2024Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY DISTAL GASTRECTOMY, STAPLER WAS USED AT THE TIME OF GASTRIC INCISION; AFTER FIRING, WHEN RETURNING THE FIRE KNOB TO ITS ORIGINAL POSITION, THE KNOB WAS ABNORMALLY HEAVY. NOTHING IN PARTICULAR WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18726964 ↗
• MalfunctionFeb 7, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664359 ↗
• MalfunctionJan 31, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN BOWEL RESECTION, DURING THE SECOND FIRING, THE DEVICE DID NOT FIRE. A SECOND OPEN STAPLER WAS USED BUT THE SAME ISSUE OCCURRED. A THIRD OPEN STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618727 ↗
• MalfunctionJan 31, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN BOWEL RESECTION, DURING THE SECOND FIRING, THE DEVICE DID NOT FIRE. A SECOND OPEN STAPLER WAS USED BUT THE SAME ISSUE OCCURRED. A THIRD OPEN STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618687 ↗
• MalfunctionJan 19, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE STAPLER DID NOT FIRE. THE PRODUCT WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548320 ↗
• MalfunctionJan 2, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE LAPAROTOMY WITH DISTAL GASTRECTOMY, WHILE ON GASTRIC RESECTION, THE TISSUE WAS CLAMPED AND CLO SING COULD BE PERFORMED, BUT WHEN THE HANDLE WAS ADVANCED AFTERWARDS, IT MOVED FOR APPROXIMATELY 1CM, BUT IT COULD NOT ADVANCE ANY FURTHER. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430629 ↗
• MalfunctionDec 22, 2023Break; Failure to Fire; Break; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN SURGERY, DURING CUTTING OF THE TISSUE, THE HANDLE OF THE DEVICE BROKE AND COULD NOT BE FIRED. A NEW OPEN STAPLER WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18386953 ↗
• MalfunctionDec 21, 2023Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, THE DEVICE COULD NOT BE COMBINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370533 ↗
• MalfunctionOct 27, 2023Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PANCREATICODUODENECTOMY (WHIPPLE PROCEDURE), WHEN THE TISSUE WAS SET IN GASTRECTOMY, THE FIRING KNOB COULD NOT BE ADVANCED. FIRING COULD NOT BE PERFORMED. ADDITIONALLY, THE DEVICE PRE-FIRED. TO RESOLVE THE ISSUE, A NEW DEVICE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18025226 ↗

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-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-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-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-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-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-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-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-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT

…and 58 more.