TA TA3035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10884521043114), received between Dec 1, 2016 and Aug 5, 2026 — classified as 17 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (37 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50149815 ↗
• MalfunctionApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, AFTER FIRING, THE STAPLE LINE DID NOT HOLD. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tissue Breakdown

  MAUDE report 24941818 ↗
• MalfunctionJul 30, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE OPEN STAPLER, THE SURGEON PERFORMED FULL, COMPLETE SQUEEZES OF THE HANDLE BUT THE STAPLES DID NOT DEPLOY. THE PROCEDURE WAS EXTENDED BY TWO HOURS AS A RESULT. TO RESOLVE THE ISSUE, A NEW CIRCULAR STAPLER WAS USED AND THE AFFECTED TISSUE WAS RESECTED AND RE-STAPLED.

  Patient problems: Tissue Breakdown

  MAUDE report 22661909 ↗
• InjuryOct 16, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLER FAILED TO DEPLOY WHICH RESULTED IN A COLOANAL ANASTOMOSIS AS OPPOSED TO A STOKED ULTRA LOW. SUTURING AS A STAPLE LINE REPLACEMENT WAS DONE TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED AND AN ADDITIONAL SURGERY WAS DONE.

  Patient problems: Tissue Breakdown

  MAUDE report 20461782 ↗
• MalfunctionJun 18, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHEN THE SURGEON OPENED THE DEVICE WITH THE STAPLE RELOAD, SOME OF THE STAPLES WERE ALREADY COMING OUT OF THE RELOAD, AND THE STAPLER ITSELF WOULD NOT FIRE. A NEW LINEAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559776 ↗
• MalfunctionJun 13, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, THE STAPLER WOULD NOT FIRE, WHEN THE USER OPENED THE STAPLE CARTRIDGE IT CAME WITH, SOME OF THE STAPLES WERE ALREADY COMING OUT OF THE CARTRIDGE.

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

  MAUDE report 19528488 ↗
• 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 19173606 ↗
• MalfunctionMar 27, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN ANTERIOR RESECTION, DURING STAPLING OF THE SIGMOID COLON, THE STAPLER DID NOT ENGAGE INTO FIRING POSITION. A SECOND STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986600 ↗
• MalfunctionDec 18, 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 18352497 ↗
• MalfunctionDec 7, 2023Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; 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 18285389 ↗
• MalfunctionOct 30, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN SURGERY FOR RECTAL CANCER, IN AN ATTEMPT TO DISSECT THE RECTUM, THE DEVICE COULD NOT BE FIRED. 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 18031408 ↗
• MalfunctionJul 13, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE STAPLES DID NOT DEPLOY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316811 ↗
• MalfunctionJun 20, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A PROCEDURE THE STAPLES DID NOT DEPLOY AFTER SQUEEZING THE HANDLE. AS PER THE NURSE NO AUDIBLE FEEDBACK WAS HEARD INDICATING THAT THE STAPLES CAME OUT. MANUAL SUTURING AND CUTTING WAS PERFORMED TO RESOLVE THE ISSUE. THE OPERATION WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE DEVICE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17161007 ↗
• InjuryMay 16, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A COLON RESECTION, WHEN TRANSECTING THE COLON THE DEVICE DID NOT FIRE. THE COLON HAD TO BE RESECT DUE TO THE MALFUNCTION. IT WAS NOTED THAT THERE WAS TISSUE LOSS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16940589 ↗
• MalfunctionMar 8, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STAPLES DID NOT DEPLOY. IT WAS NOTED THAT THE PRODUCT WAS NOT USED. THE DEVICE REPLACED TO ANOTHER NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504432 ↗
• InjuryDec 27, 2022Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ANTERIOR RESECTION, WHEN APPLYING ON RECTUM, THE DEVICE FAILED TO FIRE STAPLES. TISSUE WAS CUT AFTER THE SURGEON THOUGHT THE STAPLES HAD BEEN DEPLOYED. ENTEROTOMY WAS MANAGED AND RECRUITED STAFF TO HAND SEW COLOANAL ANASTOMOSIS TO RESOLVE THE ISSUE. SURGICAL TIME WAS EXTENDED BY APPROXIMATELY AN HOUR. THE EVENT ALSO LED TO MINIMAL BLOOD LOSS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16050645 ↗
• MalfunctionDec 9, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN LEFT HEMICOLECTOMY, WHILE PREPARING TO DETACH THE TRANSVERSE COLON, FULL, COMPLETE SQUEEZES OF THE HANDLE WAS PERFORMED, THE HANDLE RETURNED TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE AND DID NOT REMAIN IN THE CLOSED POSITION FOLLOWING THE SECOND COMPLETE SQUEEZE BUT 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 15953591 ↗
• MalfunctionDec 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE STAPLE CARTRIDGE DISASSEMBLED WHEN PUT INTO THE PATIENT LAPAROSCOPICALLY. THE SURGEON RETRIEVED THE STAPLE CARTRIDGE AND ENSURED THERE WERE NO PIECES LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924780 ↗
• MalfunctionSep 16, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN LOBECTOMY, WHEN DETACHING THE TRACHEA, THE STAPLER DID NOT FIRE. THE HANDLE DID NOT REMAIN IN THE CLOSED POSITION FOLLOWING THE SECOND COMPLETE SQUEEZE OF THE HANDLE. A NEW STAPLER WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437740 ↗
• MalfunctionSep 6, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE DID NOT FIRE. ANOTHER STAPLE WAS USED TO THE PATIENT TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15363777 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 5 DAYS POSTOPERATIVE OF A ZENKER'S DIVERTICULECTOMY, THE PATIENT HAD A STAPLE LINE LEAK. THE LEAK WAS TREATED BY VACUUM-ASSISTED CLOSURE (VAC) DRESSING. THE PATIENT ALSO HEALED UP WITH ANTIBIOTICS.

  Patient problems: Failure to Anastomose; Stenosis

  MAUDE report 15349226 ↗
• InjuryAug 12, 2022Failure to Form Staple; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ONE DAY POSTOPERATIVE TO OPEN ZENKER'S DIVERTICULECTOMY, THE SURGEON HAD TO BRING THE PATIENT BACK TO THE OPERATING ROOM BECAUSE THE WOUND WAS POURING PUS. ON EXAMINATION, THE SURGEON FOUND DEFORMED STAPLES ON THE WOUND, LEAVING THE ANASTOMOSIS OPEN.

  Patient problems: Failure to Anastomose; Purulent Discharge; Unspecified Tissue Injury

  MAUDE report 15220345 ↗
• MalfunctionJun 11, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE DEVICE WAS NOT ABLE TO FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14665105 ↗
• MalfunctionApr 26, 2022Break; Failure to Fire; Break; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN COLON RESECTION, WHEN PREPARING TO STITCH THE INTESTINES, THE DEVICE BROKE AND STAPLE WAS NOT HIT. 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 14215068 ↗
• MalfunctionJan 6, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN RADICAL SURGERY FOR ESOPHAGEAL CANCER, WHILE IN THE SEVERED BLOOD VESSEL, THE DEVICE PARTIALLY FIRED. THE SURGEON USED A NEW DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177878 ↗

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-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-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-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-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-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-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

…and 58 more.