TA TA4535SRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10884521043176), received between Jun 9, 2017 and Jul 29, 2025 — classified as 12 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (41 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN THE STAPLER WAS OPENED DURING THE SURGERY, THE STAPLER WOULD NOT FIRE CORRECTLY.

  Patient problems: Insufficient Information

  MAUDE report 22643107 ↗
• MalfunctionJul 9, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN THE STAPLER OPENED FOR SURGERY, THE STAPLER WOULD NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462338 ↗
• MalfunctionMay 26, 2025Failure 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, THE STAPLE DID NOT ATTACH. IT WAS NOTED THAT THERE WAS SURGICAL TIME EXTENDED.

  Patient problems: Insufficient Information

  MAUDE report 22084964 ↗
• MalfunctionJan 3, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE OPEN RELOADABLE STAPLER, THERE WERE PROBLEMS WITH FIRING THE STAPLER, RESULTING IN AN INCOMPLETE STAPLE LINE.

  Patient problems: Insufficient Information

  MAUDE report 21072387 ↗
• MalfunctionAug 8, 2024Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19936259 ↗
• InjuryApr 24, 2024Difficult to Open or Close; Mechanics Altered; Physical Resistance/Sticking; Difficult to Open or Close; Mechanics Altered; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY RECTAL MALIGNANT TUMOR RESECTION, IN RECTAL RESECTION, AFTER SQUEEZING THE HANDLE TWICE AT FIRING, THE HANDLE BECAME STIFF WITHOUT RETURNING TO ITS ORIGINAL POSITION. THE SUTURES IN THE RECTUM HAD NOT BEEN MADE, AND THE SURGEON CUT THE TISSUE. IT WAS NOT POSSIBLE TO VISUALLY CHECK WHETHER THE STAPLE HAD BEEN APPLIED OR NOT. BECAUSE THE REMAINING RECTUM WAS SMALL, HARTMANN'S SURGERY WAS PERFORMED INSTEAD OF A FORCED ANASTOMOSIS, AND A COLOSTOMY WAS CREATED. THIS RESULTED IN PERMANENT TISSUE DAMAGE. DUE TO OLD AGE, THERE WAS NO PLAN TO PERFORM RE-ANASTOMOSIS SURGERY. WHEN THE DEVICE WAS OPERATED OUTSIDE AFTER THE SURGERY, THE JAWS DID NOT CLOSE EVEN THOUGH THE HANDLE WAS FULLY SQUEEZED, AND THE HANDLE DID NOT RETURN TO ITS ORIGINAL POSITION.

  Patient problems: Tissue Breakdown

  MAUDE report 19173856 ↗
• MalfunctionApr 9, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTROINTESTINAL AND COLON SURGERY, AT THE TIME OF INTESTINAL RESECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. THEREFORE, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, THE SURGEON REPLACED THE ORIGINALLY ATTACHED RELOAD THAT CAME WITH THE STAPLER WITH A NEW RELOAD. THE SAME HANDLE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070067 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, OF A BOWEL TRANSECTION PROCEDURE, THE SURGEON FOUND OUT DURING THE HYSTERECTOMY PROCEDURE OF THE PATIENT THAT FROM THE PREVIOUS ANASTOMOSIS OF ILEOCOLIC ENTEROTOMY, THE PATIENT HAD A STAPLE LINE LEAK. THE STAPLE LINE WAS COMPLETE ON THE ENDS BUT WAS NOT SEALED IN THE MIDDLE. THE SURGEON LOCATED THE LEAKS AROUND THE ILEOCOLIC ENTEROTOMY AND CAUSED A SMALL BOWEL LEAK. IT HAD AN OFFSET REGULAR STAPLE LINE WHEN BROUGHT TOGETHER.

  Patient problems: Bowel Perforation; Failure to Anastomose

  MAUDE report 18566699 ↗
• MalfunctionNov 13, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN CONSTRUCTION OF COOK'S RESERVOIR PROCEDURE, THE DEVICE DID NOT FIRE. AN EXTRA RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18127964 ↗
• MalfunctionAug 21, 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, DURING AN OPEN RECTOSIGMOIDECTOMY PROCEDURE, THE DEVICE DID NOT FIRE. THE SURGEON TRIED THREE TIMES AND WAS UNABLE TO FIRE, AND ONLY AFTER REMOVAL DID IT FIRE OUT OF THE TISSUE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. TO RESOLVE THE ISSUE, THE SURGEON HAD TO BE DONE MANUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592948 ↗
• MalfunctionMay 2, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC LARYNGECTOMY, THE DEVICE 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 16853701 ↗
• MalfunctionApr 24, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE STAPLER DID NOT WORK. THE DEVICE DID NOT FIRE. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797854 ↗
• MalfunctionMar 3, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL HYSTERECTOMY, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482714 ↗
• MalfunctionSep 16, 2022Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING AN OPEN COLECTOMY, WHILE COLECTOMY WAS BEING PERFORMED, THE DEVICE DID NOT FIRE; IT COULD NOT BE SQUEEZED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439426 ↗
• MalfunctionSep 6, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE DEVICE WAS DIFFICULT OR UNABLE TO OPEN. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363369 ↗
• MalfunctionJul 29, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE; THE HANDLE WAS NOT FULLY SQUEEZED.

  Patient problems: Insufficient Information

  MAUDE report 15136268 ↗
• InjuryJul 11, 2022Failure to Form Staple; Failure to Fire; Expulsion; Failure to Form Staple; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, ON AN OPEN ABDOMINAL APPENDECTOMY, DURING THE RESECTION OF THE APPENDIX, THE HANDLE WAS SQUEEZED BUT NOT ALL THE STAPLES WERE FIRED. THE DEVICE WAS REMOVED AND HAND-SUTURING WAS PERFORMED TO FIX THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14982119 ↗
• MalfunctionApr 20, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, BEFORE THE DEVICE WAS CLAMPED OVER TISSUE, THE JAWS WERE DIFFICULT OR UNABLE TO OPEN. ANOTHER STAPLE WAS USED WITH NEW ONE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14163435 ↗
• InjuryApr 15, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE CLOSURE OF ENTEROSTOMY, THE DEVICE WAS ABLE TO FIRE PARTWAY THROUGH BUT DID NOT ENGAGE THE TISSUE.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 14118677 ↗
• MalfunctionDec 21, 2021Failure to Align; Difficult to Open or Close; Failure to Align; Difficult to Open or Close

  ACCORDING TO THE REPORTER, ON A SINGLE INCISION LAPAROSCOPIC SURGERY (SILS) ILEOCECETOMY, WHEN STAPLING THE BOWEL, THE HANDLE WOULD NOT CLOSE. ANOTHER DEVICE WAS USED BUT 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 13056548 ↗
• MalfunctionOct 21, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN CHOLECYSTECTOMY, THE DEVICE DID NOT FIRE.

  Patient problems: Insufficient Information

  MAUDE report 12673793 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ONE MONTH POSTOPERATIVE TO OPEN COLORECTAL SURGERY, THE PATIENT HAD TO UNDERGO EMERGENCY SURGERY IN ANOTHER HOSPITAL BECAUSE THE STAPLES WERE OPENED.

  Patient problems: Failure to Anastomose

  MAUDE report 12018064 ↗
• MalfunctionMay 3, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING RECTUM RESECTION, ALL THREE (3) DEVICES DID NOT FIRE. THE SURGEON CANNOT PERFORM FULL, COMPLETE SQUEEZES OF THE HANDLE. IT STOPPED BEFORE LOCK. THE SITUATION WAS CONTROLLED AND THE RECTUM WAS BEING OPEN AND THERE WAS NO PROBLEM. IT WAS NOTED THAT THE SURGERY TAKES 15 MINUTE LONGER THAN REGULAR PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760087 ↗
• MalfunctionMar 30, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A COLOSTOMY, THE SURGEON WAS ABLE TO PERFORM FULL, COMPLETE SQUEEZES OF THE HANDLE BUT STAPLER DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591549 ↗
• MalfunctionJan 5, 2021Failure 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 11116292 ↗

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-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-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-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-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-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-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-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-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

…and 58 more.