GIA GIA6025SRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884523007213), received between Nov 9, 2017 and Jan 28, 2025 — classified as 1 injury, 42 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (18 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Failure to Align; Difficult to Open or Close; Failure to Align; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, DURING SET-UP, THE DIFFICULT OR UNABLE TO CLOSE. THERE WAS AN ISSUE WITH THE HINGE. THE DEVICE WAS ALSO DIFFICULT TO OPEN. DURING ASSEMBLY, THE DEVICE WOULD NOT STAY TOGETHER. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249719 ↗
• MalfunctionJan 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE BLADE OF THE CARTRIDGE POPPED UP THE MOMENT THE HANDLE WAS INSTALLED AND OPENED AFTER THE STAPLE WAS MOUNTED. THE CARTRIDGE WAS LOADED SUCCESSFULLY BUT THEN POPPED OFF WHEN THE HANDLE WAS ATTEMPTED TO BE PUT TOGETHER. ANOTHER CARTRIDGE WAS USED BUT THE SAME ISSUE OCCURRED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21191871 ↗
• MalfunctionNov 25, 2024Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771944 ↗
• MalfunctionNov 13, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE. 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 20674314 ↗
• MalfunctionNov 21, 2023Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185750 ↗
• MalfunctionNov 14, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED. THE DEVICE DID NOT FIRE.

  Patient problems: Insufficient Information

  MAUDE report 18133370 ↗
• MalfunctionMay 18, 2023Retraction Problem; Insufficient Device Problem Information; Retraction Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE LAPAROTOMY LIVER RESECTION, AFTER FIRING, WHEN AN ATTEMPT WAS MADE TO RETURN THE KNIFE, THE SAFETY ENGAGED, BUT THE KNIFE STOPPED HALFWAY AND DID NOT RETURN UNTIL THE PROXIMAL SIDE. THE HANDLE WAS ABLE TO WORK NORMALLY WITH OTHER LOADING UNITS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953500 ↗
• MalfunctionDec 6, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT FIRE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 15927574 ↗
• MalfunctionDec 6, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY LEFT COLON RESECTION, WHILE RESECTING THE LEFT COLON, THE LEFT COLON WAS CUT NORMALLY FOR THE FIRST TIME, THEN FOR THE SECOND TIME, A NEW CARTRIDGE WAS ATTACHED BUT THE FIRING KNOB DID NOT ADVANCE EVEN IT WAS TRIED TO FIRE EMPTY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND THE OPERATION WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927223 ↗
• MalfunctionAug 10, 2022Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202298 ↗
• MalfunctionAug 10, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. A NEW PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201470 ↗
• MalfunctionJul 22, 2022Break; Break

  ACCORDING TO THE REPORTER, THE BLACK FIRING LEVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089766 ↗
• MalfunctionMar 8, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694218 ↗
• MalfunctionFeb 7, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT FIRE.

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

  MAUDE report 13471795 ↗
• MalfunctionJan 27, 2022Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE DEVICE WAS DIFFICULT OR UNABLE TO CLOSE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13376974 ↗
• MalfunctionJan 6, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A LAPAROSCOPY, THE JAWS DID NOT OPEN BEFORE CLAMPING ON THE TISSUE. ANOTHER CARTRIDGE WAS USED TO RESOLVE THE CONCERN.

  Patient problems: Insufficient Information

  MAUDE report 13178177 ↗
• MalfunctionDec 30, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PYLORUS-PRESERVING PANCREATICODUODENECTOMY, THE DEVICE DID NOT FIRE. A NEW HANDLE AND RELO AD WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119278 ↗
• MalfunctionDec 17, 2021Failure to Align; Difficult to Open or Close; Failure to Align; Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER DID NOT CLOSE FIRMLY FOR STAPLING THE TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 13024645 ↗
• MalfunctionAug 12, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE BLACK THUMB PIECE OF THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315677 ↗
• MalfunctionAug 9, 2021Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293539 ↗
• MalfunctionMay 25, 2021Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING OPEN HEPATECTOMY, THE JAWS OF THE STAPLER DID NOT OPEN AFTER FIRING AND CLAMPING OVER TISSUE. THE STAPLER WAS REMOVED BY FORCE AND PRIED OFF USING AN ADDITIONAL TOOL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11880840 ↗
• MalfunctionMay 25, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORT, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. A NEW PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876334 ↗
• MalfunctionMay 14, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING OPEN SURGERY, THE FORMATION OF STAPLE WAS INCOMPLETE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826590 ↗
• MalfunctionApr 1, 2021Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, PREOPERATIVE TO PYLORUS PRESERVING PANCREATODUODECTOMY (PPPD), THE DEVICE WOULD NOT FIRE. THE DEVICE WAS FOUND PREFIRED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606680 ↗
• MalfunctionFeb 5, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE KNIFE STOPPED IN THE MIDDLE OF CARTRIDGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11285292 ↗

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 tr
• 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-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-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-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-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-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-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-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-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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

…and 58 more.