Endo GIA 030426Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523003000), received between Jan 17, 2018 and Dec 11, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (2 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2020Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, SOME STAPLES AT THE END OF THE STAPLE LINE WERE MALFORMED. ALSO, A SMALL METAL PIECE FROM TISSUE GAP CONTROL BROKE OFF AND FELL IN THE PATIENT'S CAVITY, WHICH WAS RETRIEVED USING GRASPING FORCEPS. A SECOND STAPLE LINE WAS MADE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THE EVENT RESULTED TO UNANTICIPATED TISSUE LOSS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10990864 ↗
• MalfunctionOct 10, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO RADICAL NEPHRECTOMY, THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7951383 ↗
• MalfunctionOct 10, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO RADICAL NEPHRECTOMY, THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7951345 ↗
• MalfunctionJan 17, 2018Bent; Failure to Form Staple; Human-Device Interface Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Bent; Failure to Form Staple; Human-Device Interface Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, WHILE FIRING ACROSS THE MESENTERY/SHORT GASTRIC VESSELS. THE DEVICE FIRED AND THERE WERE NO ABNORMALITIES NOTED UNTIL AFTER THE RELOAD WAS FIRED AND BLOOD BEGAN TO GUSH. THE DEVICE WAS RETRACTED AND SURGEON NOTICED THAT ONLY ONE SIDE OF THE STAPLES ACTUALLY DEPLOYED. UPON EXAMINATION OF THE RELOAD, IT WAS NOTED THAT IT WAS WARPED/BENT. THE RELOAD WAS NOT ABLE TO FULLY CLOSE AND WOULD NOT UNLOAD FROM THE HANDLE. THE STAPLER WAS ABLE TO FIRE BUT HAD POOR STAPLE FORMATION. THE STAPLE LINE WAS FIXED WITH THE USE OF CAUTERY AND ANOTHER STAPLE RELOAD TO CONTROL THE BLEEDING. THERE WAS NO PATIENT INJURY REPORTED. PATIENT IS DOING FINE AND WAS RELEASED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7201754 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825. 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-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-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-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-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-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-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-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-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-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.