GIA GIA10048LRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884521031708), received between Mar 14, 2017 and Aug 6, 2026 — classified as 4 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (13 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50154492 ↗
• MalfunctionNov 4, 2025Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CARTRIDGE BROKE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465527 ↗
• MalfunctionMay 8, 2025Misfire; Failure to Fire; Misfire; Failure to Fire

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985554 ↗
• MalfunctionOct 9, 2024Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE RELOAD WAS BROKEN. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409987 ↗
• MalfunctionApr 26, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, THE STAPLES DID NOT DEPLOY.

  Patient problems: Insufficient Information

  MAUDE report 19197503 ↗
• MalfunctionJan 3, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STAPLES DID NOT DEPLOY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439967 ↗
• MalfunctionDec 22, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN HEMICOLECTOMY, THE STAPLER DID NOT FIRE. A DIFFERENT KIND OF OPEN STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. IT WAS NOTED THAT STAPLER COULD BE FIRED MANUALLY AFTER IT WAS TAKEN BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387273 ↗
• MalfunctionSep 1, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMICOLECTOMY, OPEN PROCEDURE, THE DEVICE PARTIALLY FIRED, WHEN THE DEVICE WAS USED TO ANASTOMOSE THE COLON, THE END OF THE CARTRIDGE DID NOT FIRE PROPERLY, AN EXTRACORPOREAL ANASTOMOSIS WAS COMPLETED USING ANOTHER CARTRIDGE. THERE WAS NO PATIENT INJURY.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674440 ↗
• InjuryMar 6, 2023Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMICOLECTOMY - EXTERNAL ANASTOMOSIS PROCEDURE, AT THE BOWEL, THE DEVICE PARTIALLY FIRED AND THERE WAS AN INCOMPLETE STAPLE LINE. LACK OF POSSIBILITY TO MOVE THE FIRING KNOB. THE STAPLE LINE WAS FIXED BY OVER SEWING. BOTH THE STAPLER AND LOADING UNIT WERE REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16486649 ↗
• MalfunctionFeb 7, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY BEFORE USING ON PATIENT, THE DEVICE DID NOT FIRE. ANOTHER CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16309652 ↗
• MalfunctionDec 13, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING AN OPEN BOWEL RESECTION, WHILE ON THE LARGE BOWEL, THE DEVICE ONLY FIRED ACROSS 20% OF TISSUE THEN STOPPED AND WOULD NOT ADVANCE ANY FURTHER. IT WAS BEING FIRED ACROSS ANOTHER STAPLE LINE. ANOTHER CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970958 ↗
• MalfunctionDec 6, 2022Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928399 ↗
• MalfunctionSep 16, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY BOWEL RESECTION, WHILE AT THE ANASTOMOSIS, THE RELOAD WAS LOADED AND FITTED WELL INTO THE HANDLE BUT THE HANDLE DID NOT FIRE AND IT WAS STUCK. THE SURGEON OPENED A NEW HANDLE TO RECTIFY THE ISSUE AND TRIED TO PUT THE SAME RELOAD BUT IT HAS THE SAME RESULT OF FEELING STUCK WHEN TRYING TO CUT. A NEW RELOAD WAS OPENED AND USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15440007 ↗
• MalfunctionAug 17, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE.

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

  MAUDE report 15243334 ↗
• MalfunctionJul 12, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, DURING THE TEST USE, THE DEVICE COULD NOT BE FIRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988933 ↗
• MalfunctionMay 17, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, AFTER SQUEEZING THE HANDLE, THERE WAS A PROBLEM WITH THE FIRING OF THE STAPLER, SO THE RELOAD DID NOT FIRE.

  Patient problems: Insufficient Information

  MAUDE report 14418227 ↗
• MalfunctionApr 8, 2022Break; Failure to Form Staple; Break; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE KNIFE EJECTS AND POOR STAPLE FORMATION. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054033 ↗
• MalfunctionMar 3, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING COLECTOMY, THE DEVICE WAS UNABLE TO FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664648 ↗
• MalfunctionNov 17, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STAPLES DID NOT COME OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827611 ↗
• MalfunctionAug 23, 2021Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICES DID NOT CUT TISSUE.

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

  MAUDE report 12353544 ↗
• InjuryApr 13, 2021Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING WHIPPLE PROCEDURE, WHEN RESECTING STOMACH, POOR STAPLE FORMATION WAS OBSERVED. THERE WAS A BURST BLEEDING (NOT REACHING 50CC) IN SOME SPOT ON THE STAPLE LINE. STAPLE LINE WAS OVERSEWN TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11660804 ↗
• MalfunctionMar 11, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE TRANSECTING THE STOMACH DURING AN OPEN GASTRECTOMY, WHEN THE SURGEON WAS READY TO FIRE, IT DID NOT FIRE. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458192 ↗
• MalfunctionFeb 8, 2021Difficult or Delayed Positioning; Misfire; Difficult or Delayed Positioning; Misfire

  ACCORDING TO THE REPORTER, DURING A STOMACH TRANSECTION ON AN OPEN SUBTOTAL GASTRECTOMY, THE DEVICE REQUIRED MUCH MORE FORCE TO PUSH THE BLACK KNOB FROM THE START OF FIRING. IN THE MIDDLE OF FIRING, THEY WERE NOT ABLE TO PUSH THE BLACK KNOB. IT WAS STATED THAT ALMOST 4 CM WAS FIRED, AND 6 CM WAS LEFT. A NEW RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11292563 ↗
• MalfunctionDec 19, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE THE DEVICE WAS BEING APPLIED IN THE STOMACH IN AN OPEN GASTRECTOMY PROCEDURE, THE BLACK PUSHER THUMB PIECE COULD BE MOVED BUT THE DEVICE DID NOT FIRE. A NEW STAPLER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9498889 ↗
• MalfunctionAug 1, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A DISTAL GASTRECTOMY PROCEDURE, THE DEVICE PARTIALLY FIRED. A NEW DEVICE 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 8853610 ↗

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 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-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-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-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-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-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-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-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-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

…and 58 more.