TA TA3035LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521043107), received between Feb 19, 2019 and Jul 24, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (4 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825, K231491); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, AFTER FIRING THE RELOAD, CUT THE TISSUE, THE SURGEON OBSERVED THAT THE STAPLE LINE HAD OPENED SINCE THE RELOAD DID NOT CONTAIN STAPLES INSIDE. THE DEVICE WAS REPLACED WITH ANOTHER LOADING UNIT. THE PROCEDURE WAS EXTENDED BY 10 MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 22596783 ↗
• MalfunctionApr 24, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING ABDOMINOPERINEAL RESECTION, WHEN STAPLING THE ANAL CANAL, WHEN THE SURGEON TRIED TO PERFORM THE STAPLING LINE, THE STAPLES DID NOT DEPLOY. THE SURGEON THEN REPLACED IT WITH ANOTHER DEVICE AND RELOADED AGAIN. THE USER COULD NOT CONFIRM WHERE THE MAIN PROBLEM WAS, IF IT WAS THE STAPLER OR THE RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173689 ↗
• MalfunctionDec 21, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380163 ↗
• MalfunctionDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, PLEUROTOMY/THORACIC, THE DEVICE DID NOT FIRE. THE PATIENT WAS INTUBATED AND HAD A TEMPORARY INJURY. A NEW STAPLER WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 18288480 ↗
• MalfunctionApr 22, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN APPENDECTOMY, WHEN STAPLING THE APPENDIX, THE DEVICE DID NOT DIRE. FULL/ COMPLETE SQUEEZES OF THE HANDLE WAS NOT PERFORMED. CHANGED THE RELOAD TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9984703 ↗
• MalfunctionDec 3, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LOW ANTERIOR RESECTION, THE SURGEON TRIED TO SQUEEZE THE HANDLE FOR THE FIRST STEP SQUEEZING, BUT THE HANDLE WAS STIFF AND COULD NOT BE SQUEEZED. NEW RELOAD WAS USED AND THE SURGEON COULD SQUEEZE THE HANDLE, AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9400924 ↗
• InjuryJun 11, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, WHEN TRANSECTING THE BOWEL DURING LAPAROTOMY, PERITONEAL LAVAGE, HARTMANN'S PROCEDURE, END SIGMOID COLOSTOMY, APPENDECTOMY PROCEDURES, THE STAPLER FIRED WITH THE PRELOADED RELOAD, BUT STAPLER COULD NOT BE CLOSED ON THE TISSUE AND WAS UNABLE TO BE FIRED WHEN THE SECOND RELOAD WAS LOADED. THE SURGEON PROCESSED MANUALLY TO CLAMP, TRANSECT WITH A BLADE AND SUTURE.

  Patient problems: No Code Available

  MAUDE report 8689748 ↗
• MalfunctionFeb 19, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEPATECTOMY PROCEDURE, SURGEON KNEW THAT STAPLER IS SLIGHTLY STICKING OUT WHEN HE FIRED THE DEVICE. THEY REPLACED THE RELOAD TO COMPLETE THE CASE. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8352257 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825, K231491. 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-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-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-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-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-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-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-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-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT

…and 58 more.