TA TA3048LRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521043121), received between Jun 13, 2017 and Jul 18, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542405 ↗
• MalfunctionSep 29, 2023Component or Accessory Incompatibility; Difficult to Open or Close; Component or Accessory Incompatibility; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE DEVICE WAS NOT ABLE TO BE LOADED, IT WAS ALSO NOTED THAT THE JAW WILL NOT CLOSE. A NEW OPEN STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843641 ↗
• MalfunctionMar 1, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING THE LOWER ANTERIOR RESECTION VIA OPEN PROCEDURE WHILE TRANSACTING OF THE COLON THE DEVICE HAD A POOR STAPLE FORMATION. TO RESOLVE THE ISSUE, THE SURGEON OPENED A NEW RELOAD AND OVER SEWED THE STAPLE FORMATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637050 ↗
• InjuryNov 6, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, THE DEVICE PARTIALLY FIRED AFTER 2 FIRINGS. THE BRONCHUS WAS OPEN AFTER THE CUT, BECAUSE THE DEVICE NOT STAPLE AND MUST BE MANUALLY SUTURED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12755855 ↗
• InjuryJun 21, 2021Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  ACCORDING TO THE REPORTER, ON AN OPEN SIGMOIDECTOMY, WHILE TRANSECTING THE COLON, THE SURGEON HAD LOADED A GREEN RELOAD ONTO A BLUE HANDLE FOR THE FIRST FIRING. SURGEON SAID THE DEVICE MISFIRED AND DID NOT STAPLE. ANOTHER GREEN RELOAD WAS LOADED BUT THE STAPLES WERE BARELY DEPLOYED. ONLY THE TIPS OF THE STAPLES WERE DEPLOYED. NONE OF THE STAPLES WERE COMPLETELY DEPLOYED. A DIFFERENT DEVICE AND A SUTURE WAS USED INSTEAD.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12037486 ↗
• MalfunctionFeb 26, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TRIGGER DID NOT LOAD AND DID NOT FIRE AT THE TIME OF STAPLING. THERE WAS NO PATIENT INJURY AS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7296555 ↗
• MalfunctionFeb 22, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. AFTER THE RELOAD WAS LOADED TO DEVICE AND USED BY THE SURGEON, IT DID NOT FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7289467 ↗
• MalfunctionDec 7, 2017Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THEY WENT TO STAPLE THE BRONCHUS WITH THE FIRST STAPLER AND THE DEVICE DID NOT FIRE. A NEW RELOAD WAS USED WITH THE SAME STAPLER DEVICE. THE STAPLER PERFORMED OPEN STAPLES (NO B SHARP) IN TISSUE. THEN THEY CHANGED TO ANOTHER RELOAD AND TRIED TO FIRE OUT OF THE PATIENT BUT NOTHING HAPPENED. ANOTHER STAPLER WAS OPENED AND THAT DEVICE STAPLED THE TISSUE WITHOUT ANY PROBLEM. TO CORRECT THE ISSUE, THE TISSUE WAS RESECTED AND RE-STAPLED WITH A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7097202 ↗
• MalfunctionSep 18, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY PROCEDURE, WHILE PREPARING TO DIVIDE THE BRONCHIAL BRONCHUS, THE DEVICE DID NOT FIRE, SQUEEZING OF THE HANDLE WAS NOT COMPLETE, HANDLE DID NOT RETURN TO THE OPEN POSITION, AND DID NOT REMAIN IN THE CLOSED POSITION FOLLOWING THE SECOND COMPLETE SQUEEZE OF THE HANDLE. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873467 ↗
• InjuryJun 13, 2017Entrapment of Device; Misfire; Failure to Form Staple; Entrapment of Device; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN BRONCHIAL THROAT AND PERICARDIUM CUFF PROCEDURE. THE STAPLER PARTIALLY FIRED. THE STAPLE LINE WAS INCOMPLETE. TO FIX THE STAPLE LINE, OVER SEWED, RESECTED AND RE-STAPLED. THERE WAS TISSUE DAMAGE AS A RESULT OF THE PROBLEM. CLIP SEAM NOT COMPLETELY CLOSED AND THERE CLIPS REMAIN HANGING IN THE MAGAZINE, NEW FORKLIFT USED. THE DAMAGE WAS NOT CONSIDERED PERMANENT. THE PATIENT NEEDED A PERICARDIUM CUFF. AFTER THE PERICARDIUM CUFF AND THE OCCLUSION OF THE BRONCHIAL THROAT, THERE WAS NO FURTHER INJURY. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THE PATIENT STATUS IS ALIVE, WITH INJURY.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 6637801 ↗

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-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-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-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-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-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-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-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-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-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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

…and 58 more.