GIA GIA6048LRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521033641), received between Jun 16, 2017 and Jul 17, 2025 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE THE RELOAD WAS OPENED AT THE TIME OF STAPLING, TWO RELOADS DID NOT CONTAIN TITANIUM STAPLES AS EXPECTED. PHYSICIAN HAD TO CONTINUE THE PROCEDURE MANUALLY.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 22533037 ↗
• MalfunctionJul 17, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE THE RELOAD WAS OPENED AT THE TIME OF STAPLING, TWO RELOADS DID NOT CONTAIN TITANIUM STAPLES AS EXPECTED. PHYSICIAN HAD TO CONTINUE THE PROCEDURE MANUALLY.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 22533029 ↗
• MalfunctionJul 17, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER DID NOT FIRE COMPLETELY TO THE DISTAL END. THE ISSUE HAPPENED WITH TWO LOADING UNITS. THE TISSUE WAS RESECTED AND RE-STAPLED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR 20 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 22530719 ↗
• MalfunctionJul 17, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER DID NOT FIRE COMPLETELY TO THE DISTAL END. THE ISSUE HAPPENED WITH TWO LOADING UNITS. THE TISSUE WAS RESECTED AND RE-STAPLED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR 20 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 22530711 ↗
• MalfunctionJan 29, 2025Misfire; Failure to Cut; Misfire; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DURING FIRING, THE BLADE OF THE STAPLER DID NOT CUT ACROSS, WHICH LED TO A JAGGED STAPLE LINE WITH MISFIRED STAPLES. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE HOWEVER THE SAME ISSUE OCCURRED. ANOTHER DEVICE FROM A COMPETITOR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266441 ↗
• MalfunctionNov 29, 2024Retraction Problem; Component or Accessory Incompatibility; Retraction Problem; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING AN OPEN WHIPPLE, DURING RESECTING THE BOWEL, THE FIRST RELOAD WORKED FINED, THE SECOND RELOAD COULD NOT BE LOADED AND THEN AFTER FIRING THE SECOND TIME WITH THE SECOND RELOAD, THE KNIFE BLADE DID NOT GO DOWN. A NEW OPEN STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20811034 ↗
• MalfunctionSep 18, 2023Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765381 ↗
• InjuryFeb 23, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTRECTOMY PROCEDURE, THE SURGEON NEEDED TO CUT THE STOMACH USING A LINEAR CUTTING STAPLER. THE STAPLER HAS NO POSSIBILITY TO FIRE. IT WAS IMPOSSIBLE TO ACTUATE THE STAPLING AND THE SECTIONING OF THE STOMACH. A SECOND CLAMP WITH THE SAME MALFUNCTION CREATED A HEMATOMA ON THE STOMACH. TO RESOLVE THE ISSUE, TWO 60MM MANUAL STAPLER WAS USED IN ORDER TO COMPLETE THE CASE.

  Patient problems: Hematoma

  MAUDE report 16429466 ↗
• MalfunctionJan 12, 2023Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16147660 ↗
• MalfunctionDec 8, 2022Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941834 ↗
• MalfunctionFeb 8, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE DEVICE PARTIALLY FIRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11292145 ↗
• MalfunctionNov 3, 2020Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, ON AN OPEN ESOPHAGECTOMY, DURING THE CREATION OF THE NEO ESOPHAGUS, WHILE STAPLING THE STOMACH, THE DEVICE DID NOT CUT THE TISSUE. SCISSORS WERE USED TO TRANSECT THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779463 ↗
• InjurySep 18, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A COLECTOMY PROCEDURE, THERE WAS POOR STAPLE FORMATION. IT WAS ALSO REPORTED THAT RE-STAPLING AND RESECTION WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10556728 ↗
• MalfunctionDec 19, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE BLACK PUSHER THUMB PIECE COULDN'T BE MOVED AT ALL. AND IT WAS ALSO STATED THAT THE DEVICE PRE-FIRED AND DID NOT FIRE.

  Patient problems: No Information

  MAUDE report 9492988 ↗
• InjuryMar 12, 2019Failure 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 A STOMACH RESECTION, THE DEVICE HAD POOR STAPLE FORMATION THAT RESULTED TO STAPLE LINE BLEEDING. SURGEON HAD TO CHANGE RELOAD AND RESECT AND RE-STAPLE.

  Patient problems: No Code Available

  MAUDE report 8413808 ↗
• InjuryDec 8, 2017Failure to Form Staple; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ANASTOMOSIS OF THE DUODENUM OPEN PROCEDURE, THEY LOADED THE STAPLER AND WHEN THE SURGEON TRIED TO CLOSE THE TISSUE WITH STAPLER, THE TISSUE MOVED FROM TWO HALVES OF STAPLER. ALSO LOADING WAS NOT FIXED WELL ENOUGH IN PLACE WHERE IT SHOULD BE FIXED IN THE STAPLER. THIS LED TO AN INCOMPLETE STAPLE LINE AND THEY HAD TO RESECT AND RE-STAPLE. ALSO FOUND THE SINGLE USE STAPLER WAS DIFFICULT OR UNABLE TO CLOSE ON TISSUE BUT WAS ULTIMATELY ABLE TO CLOSE. A STAPLER OF ANOTHER MANUFACTURER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT INCURRED A DUODENUM FISTULA TEMPORARY INJURY.

  Patient problems: Fistula

  MAUDE report 7100550 ↗
• MalfunctionNov 30, 2017Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN ESOPHAGECTOMY PROCEDURE. THE STAPLING DEVICE WAS BEING USED DURING PREPARATION FOR THE TUBE. THE STAPLER DID NOT CUT TISSUE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, USED ANOTHER MANUFACTURER'S DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7073912 ↗
• MalfunctionJun 16, 2017Mechanical Problem; Failure to Fire; Mechanical Problem; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A J-POUCH PROCEDURE, THE DEVICE DID NOT FIRE AND THE KNIFE DID NOT MOVE FORWARD. ANOTHER CARTRIDGE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6646826 ↗

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-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-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-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-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-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-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-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-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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

…and 58 more.