TA TA4548LRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521043183), received between Aug 31, 2017 and Jan 22, 2026 — classified as 7 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (13 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE LOADING UNIT DID NOT FIRE DESPITE FULL, COMPLETE SQUEEZES OF THE HANDLE. THE HANDLE RETURNED TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE AND REMAINED IN THE CLOSED POSITION AFTER THE SECOND COMPLETE SQUEEZE. THE PROCEDURE REQUIRED RESECTION AND RE-STAPLING TO RESOLVE THE ISSUE. AS A RESULT, THE SURGICAL TIME WAS EXTENDED BY 20 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 24143232 ↗
• MalfunctionDec 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO LOADING UNITS DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752770 ↗
• MalfunctionDec 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO LOADING UNITS DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752754 ↗
• MalfunctionDec 8, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, TWO LOADING UNITS OF THE THORACO-ABDOMINAL STAPLER DID NOT FIRE. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739756 ↗
• MalfunctionDec 8, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER INTRA-OPERATIVELY, TWO LOADING UNITS OF THE THORACO-ABDOMINAL STAPLER 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 23739670 ↗
• MalfunctionOct 28, 2025Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER DURING A PROCEDURE, WHEN THE SURGEON PERFORMED A FULL, COMPLETE SQUEEZE OF THE HANDLE, THE STAPLES DID NOT DEPLOY. THE HANDLE RETURNED TO THE OPEN POSITION FOLLOWING THE FIRST SQUEEZE. THE SURGICAL TIME WAS EXTENDED BY 15 MINUTES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23401234 ↗
• MalfunctionApr 18, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD FIRING ISSUES AND AN INCOMPLETE STAPLE LINE. THE ACCOUNT CONFIRMED THAT FULL, COMPLETE SQUEEZES OF THE HANDLE WERE PERFORMED. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED, AND ANOTHER RELOAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869638 ↗
• MalfunctionJan 22, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLE LINE WAS INCOMPLETE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21208610 ↗
• MalfunctionJun 10, 2024Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LOWER ANTERIOR RESECTION, IN THE ANASTOMOSIS OF THE DISTAL PART OF THE RECTUM, THE SURGEON PERFORMED A FULL, COMPLETE SQUEEZE OF THE HANDLE, BUT IT DID NOT COMPLETELY FIRE. THE STAPLE THAT DID NOT COMPLETELY FIRE FELL INTO THE PATIENT¿S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE STAPLES. TO COMPLETE THE CASE, SUTURES WERE HAND-SEWN. THIS RESULTED IN MORE THAN 30 MINUTES OF SURGERY EXTENSION.

  Patient problems: Failure to Anastomose

  MAUDE report 19499001 ↗
• MalfunctionJan 19, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN 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 18545992 ↗
• MalfunctionJul 14, 2023Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN LOWER ANTERIOR RESECTION, WHEN THE DEVICE WAS APPLIED ON RECTUM, THE STAPLE LINE WAS INCOMPLETE. TO RESOLVE THE ISSUE, SUTURE WAS USED AT LEAKAGE SITE FOR CLOSURE. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) AS STANDARD PROTOCOL AFTER THE PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17325802 ↗
• MalfunctionApr 10, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE DEVICE PARTIALLY FIRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710196 ↗
• MalfunctionMar 15, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE DID NOT FIRE. THE LOADING UNIT WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547916 ↗
• InjuryJan 10, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION FOR CLOSING STUMP OF RECTUM, AFTER FIRING THE STAPLER GOT OPEN AND THERE WERE NO ANY STAPLES. A RE-OPERATION WAS NECESSARY AND THE SURGICAL TIME WAS EXTENDED DUE TO THE DEVICE PROBLEM. THE SURGEON MADE A HARTMAN POUCH AND COLOSTOMY FOR THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16131280 ↗
• InjuryJun 27, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, SUTURING WAS DONE SINCE THE STAPLE RELOAD DID NOT FIRE.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 14835697 ↗
• MalfunctionMar 9, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. THE DEVICE WAS CHANGED FOR A NEW PRODUCT TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13710821 ↗
• MalfunctionDec 16, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, THE STAPLES OF THE TWO DEVICES DID NOT COME OUT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017415 ↗
• InjuryAug 11, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING OPEN BOWEL SURGERY, STAPLES DID NOT DEPLOY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12306928 ↗
• InjuryApr 12, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN LOW ANTERIOR RESECTION, UPON ANASTOMOSIS OF INTESTINE, WHEN SURGEON HAS FIRED THE STAPLERS, STAPLE PINS DID NOT FIRED. SURGERY HAS EXTENDED FOR ALMOST 3 HOURS AS PRODUCT FAILED IN FIRST STEP OF ANASTOMOSIS AND UNANTICIPATED TISSUE LOSS WAS NOTED. SURGEON COMPLETE SURGERY BY USING SUTURES.

  Patient problems: Failure to Anastomose

  MAUDE report 11652744 ↗
• MalfunctionDec 3, 2020Failure 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 10941794 ↗
• MalfunctionSep 30, 2020Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA, THE FRONT YELLOW SECTION SEPARATED. THE CARTRIDGE DID NOT FIRE. THE DEFECTIVE ITEMS WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10610522 ↗
• InjuryOct 20, 2019Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING RESECTION OF BOWEL ON A LOW ANTERIOR RESECTION, THE DEVICE PARTIALLY FIRED AND HAD A POOR STAPLE FORMATION. STAPLE INCOMPLETE WAS ALSO NOTED DURING INSERTION OF THE DEVICE FOR END TO END ANASTOMOSIS. ANOTHER STAPLER WAS USED AND SAME ISSUE OCCURRED. ADDITIONALLY, THE STAPLE DISENGAGED TO PATIENT'S CAVITY AND WERE LEFT AS IS OFTEN DONE WITH LOOSE STAPLES. THE SURGEON HAD TO MANUALLY OVERSEW THE STAPLE LINE TO CORRECT THE ISSUE. SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES. THE PATIENT WAS BROUGHT BACK FOR SURGERY THE NEXT DAY AND IS CURRENTLY IN INTENSIVE CARE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9212537 ↗
• MalfunctionJul 10, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING OPEN COLECTOMY, THE JAWS WOULD NOT OPEN BEFORE THE DEVICE WAS CLAMPED OVER TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777414 ↗
• MalfunctionAug 31, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN ANTERIOR RESECTION, THE DEVICE DID NOT FIRE. THEY REPLACED WITH ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838959 ↗
• MalfunctionJun 11, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, LAPAROSCOPIC LOW ANTERIOR RESECTION WITH LOOP ILEOSTOMY, WHILE THE DEVICE WAS BEING APPLIED TO THE BOWEL, STAPLES DID NOT DEPLOY. THE TISSUE WAS CUT THINKING THAT THE STAPLES HAD DEPLOYED. THE OPEN TISSUE WAS MANAGED AND STAPLED STUMP WITH ANOTHER MANUFACTURER'S PRODUCT. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT FIRE USING A SECOND LOADING UNIT WHICH UNEXPECTEDLY OPEN BOWEL LUMEN. NEW INSTRUMENT WAS REQUIRED AND SUTURES WERE PLACED. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7587048 ↗

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-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-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-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-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-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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• 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

…and 58 more.