TA TA4535LRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521043169), received between Jan 18, 2018 and Mar 31, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PIN OF THE RELOAD FELL OUT DURING LOADING INTO THE HANDLE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730694 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN END-TO-END ANASTOMOSIS. DURING SURGERY THE STAPLER MISFIRED WHILE TRYING TO CLOSE THE DESCENDING COLON LEAVING THE RECTUM WIDE OPEN. THIS CAUSED SOME CONTAMINATION WHICH WAS CLEANED/IRRIGATED EXTENSIVELY. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED BLOATING, NAUSEA, HERNIA, ADHESIONS, <(>&<)> PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, REVERSAL OF LOOP ILEOSTOMY, CT SCAN, REPAIR OF PARASTOMAL HERNIA, USE OF STAPLER FOR ANASTOMOSIS, ENTEROTOMY CLOSED WITH STAPLER, NG TUBE, TAP BLOCK, HERNIA REPAIR WITH MESH, USE OF ABDOMINAL BINDER, <(>&<)> USE OF JP DRAIN.

  Patient problems: Abdominal Distention; Adhesion(s); Hernia; Nausea; Pain; Unspecified Tissue Injury

  MAUDE report 19918434 ↗
• MalfunctionJul 9, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOADING UNIT DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702041 ↗
• MalfunctionJul 9, 2024Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701722 ↗
• MalfunctionDec 13, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN AN OPEN SMALL BOWEL RESECTION, THE DEVICE DID NOT FIRE. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18323711 ↗
• MalfunctionSep 14, 2022Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, THE DEVICE PRE-FIRED AND WAS NOT ABLE TO FIRE.

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

  MAUDE report 15420327 ↗
• MalfunctionNov 9, 2021Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783784 ↗
• MalfunctionJan 2, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR BOWEL RESECTION OPEN PROCEDURE, THE SURGEON TRIED TO SQUEEZE THE HANDLE BUT IT WOULD NOT MOVE AND THE DEVICE DID NOT FIRE. A NEW RELOAD WAS USED BUT SAME THING HAPPENED. ANOTHER PRE-LOADED STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537974 ↗
• MalfunctionDec 18, 2019Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, WHILE THE NURSE WAS PREPARING THE DEVICE DURING A PROCEDURE, THE DEVICE DID NOT FIRE BECAUSE IT HAD PREFIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490091 ↗
• InjuryDec 7, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, WHEN THE STAPLER WAS BEING USED TO STAPLE THE RECTUM, THE STAPLER MISFIRED. DUE TO THE POSITION OF THE STAPLE LINE LOW IN THE RECTUM, THE SURGEON HAD TO CHANGE THE APPROACH TO REPAIR THE DEFECT AND HAD TO SUTURE TRANS-ANALLY TO COMPLETE THE CASE. THE SURGERY TIME WAS EXTENDED BY APPROXIMATELY THREE HOURS. THE RELOAD IN THE STAPLER WAS REMOVED AND REPLACED WITH ANOTHER ONE. THE INCISION WAS EXTENDED MORE THAN 1 INCH.

  Patient problems: No Code Available

  MAUDE report 8142390 ↗
• MalfunctionJul 18, 2018Failure to Fire; Firing Problem

  ACCORDING TO THE REPORTER, DURING A HARTMAN PROCEDURE, ON THE RECTUM, THE DEVICE DID NOT FIRE. THEY WERE NOT ABLE TO PERFORM FULL, COMPLETE SQUEEZES OF THE HANDLE. THE HANDLE DOES NOT RETURN TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE. THE HANDLE REMAINED IN THE CLOSED POSITION FOLLOWING THE SECOND COMPLETE SQUEEZE. THEY FIRED THE INSTRUMENT AND THAT WORKED FINE, THEN RELOAD THE STAPLER WITH A NEW RELOAD, WHEN THEY CLOSED THE INSTRUMENT THIS TIME THE HANDLE DID NOT PULL BACK AGAIN SO THEY COULD NOT DO THE SECOND SQUEEZE OR FIRING. THEY CHANGED THE RELOAD AND TRIED AGAIN, BUT THE SAME RESULT, THE HANDLE DID NOT PULL BACK AFTER THE FIRST CLOSER, SO THE INSTRUMENT COULD NOT BE FIRED AGAIN. THEY SOLVED THE SITUATION BY USING A NEW INSTRUMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7700359 ↗
• MalfunctionJan 18, 2018Failure to Fire; Mechanics Altered; Failure to Fire; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT DEPLOY OR NOT COME OUT AND STUCK INSIDE THE CARTRIDGE. OPENED ANOTHER RELOAD TO COMPLETE THE PROCEDURE. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7203772 ↗

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-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-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-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-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-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-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-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT

…and 58 more.