TA TA9035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 10884521043251), received between May 2, 2016 and Sep 22, 2026 — classified as 42 injuries, 150 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (74 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 192 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Failure to Fire

  According to the reporter, during a bowel resection, 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 50855174 ↗
• MalfunctionSep 15, 2026Failure to Form Staple

  It was reported that during an open cancer surgical procedure, some of the staples were malformed or not formed into B shapes. The user used suture to secure the area. A new device was used to resolve the issue. No patient complications were reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766617 ↗
• MalfunctionAug 16, 2026Mechanics Altered

  It was reported that during a procedure, the user stated the device was able to fire but there were no staple visible. Another device was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267331 ↗
• MalfunctionJun 23, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS FIRED, ONLY THE DISTAL PART OF THE STAPLER WAS PROPERLY EMBEDDED IN THE TISSUE, WHILE THE OTHER PARTS REMAINED OPEN. THIS RESULTED IN TISSUE BLEEDING WITH AN ESTIMATED BLOOD LOSS OF APPROXIMATELY 200 ML. THE PROCEDURE TIME WAS EXTENDED BY MORE THAN 30 MINUTES AS THE SURGICAL TEAM USED ANOTHER STAPLER TO COMPLETE THE ANASTOMOSIS AND RE-EVALUATED THE ORIGINAL STAPLER SITE. NO FURTHER BLEEDING WAS NOTED AFTER THE PROCEDURE, AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 25596626 ↗
• MalfunctionMay 4, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LEFT NEPHRECTOMY, A RELOADABLE STAPLER WAS BEING APPLIED ON THE 5TH FIRE WHEN THE INSTRUMENT DID NOT FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068610 ↗
• MalfunctionApr 15, 2026Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, STAPLER WOULD NOT CLOSED ON TISSUE, BUT WAS UNABLE TO FIRE. ANOTHER STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24882779 ↗
• MalfunctionApr 10, 2026Failure to Align; Misfire

  ACCORDING TO THE REPORTER, THE DEVICE MISFIRED. THE POST DID NOT CONNECT WITH TOP PIECE OF STAPLER CAUSING CROOKED CONNECTION, PREVENTING FROM STAPLING BOWEL PROPERLY. WE HAD TO OPEN A SECOND ONE TO STOP BLEEDING. EXTRA BOWEL WAS NEEDED TO BE REMOVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24841074 ↗
• MalfunctionApr 9, 2026Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGERY WAS EXTENDED BY 10 MINUTES AS A RESULT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24826938 ↗
• MalfunctionMar 24, 2026Misfire

  IT WAS REPORTED THAT DURING A ROBOTIC RIGHT COLECTOMY, THE DEVICE MISFIRED. THE ACCOUNT CONFIRMED THAT FULL, COMPLETE SQUEEZES OF THE HANDLE WERE PERFORMED. THE DEVICE WAS REPLACED WITH A NEW STAPLER, WHICH WAS USED WITHOUT ISSUE OR IMPACT TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682519 ↗
• MalfunctionFeb 17, 2026Failure to Align

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, THE ACCOUNT PERFORMED FULL, COMPLETE SQUEEZES OF THE HANDLE, AND THE HANDLE RETURNED TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE AND REMAINED IN THE CLOSED POSITION FOLLOWING THE SECOND COMPLETE SQUEEZE. THE DEVICE HAD BLADES ON BOTH SIDES THAT WERE NOT ORIGINALLY ALIGNED, RESULTING IN A 3 MILLIMETER CUTTING DEVIATION. THIS DEFECT REQUIRED A RESUMPTION OF THE ANASTOMOSIS FOR THE PATIENT.

  Patient problems: Failure to Anastomose

  MAUDE report 24369170 ↗
• MalfunctionDec 25, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING AN OPEN COLECTOMY, THE THREE OPEN STAPLERS MISFIRED. A NEW OPEN STAPLER WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892522 ↗
• MalfunctionDec 25, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING AN OPEN COLECTOMY, THE THREE OPEN STAPLERS MISFIRED. A NEW OPEN STAPLER WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892512 ↗
• MalfunctionDec 25, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING AN OPEN COLECTOMY, THE THREE OPEN STAPLERS MISFIRED. A NEW OPEN STAPLER WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892384 ↗
• MalfunctionNov 19, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THERE WAS INCOMPLETE STAPLE LINE WHILE TRANSECTING THE COLON. THE PROCEDURE WAS CONVERTED FROM LAPAROSCOPIC TO OPEN. TO ADDRESS THE DEVICE ISSUE, THE AFFECTED TISSUE WAS RESECTED AND RE-STAPLED.

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

  MAUDE report 23596665 ↗
• MalfunctionNov 14, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING USE OF THE LINEAR OPEN STAPLER, FULL COMPLETE SQUEEZES OF THE HANDLE WERE PERFORMED, BUT THE STAPLES DID NOT DEPLOY. THE DEVICE WAS REPLACED WITH ANOTHER TYPE OF LINEAR STAPLER.

  Patient problems: Tissue Breakdown

  MAUDE report 23554410 ↗
• MalfunctionOct 15, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN COLON PROCEDURE, THE DEVICE EXPERIENCED FIRING ISSUES, AN INCOMPLETE STAPLE LINE, AND STAPLES DID NOT FORM CORRECTLY. IT WAS FURTHER REPORTED THAT THE END OF THE ANASTOMOSIS REMAINED OPEN.

  Patient problems: Failure to Anastomose

  MAUDE report 23298161 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC RIGHT COLON PROCEDURE, THE OPEN STAPLERS APPEARED TO FIRE CORRECTLY, WITH STAPLE LINES INITIALLY LOOKING GOOD. HOWEVER, TWO DAYS POSTOPERATIVELY, AN ANASTOMOTIC LEAK WAS IDENTIFIED AT THE INTERSECTION OF THE STAPLE LINES. THE PATIENT REQUIRED AN ADDITIONAL SURGERY TO FIX THE LEAK OR THE LARGE HOLE AT THE INTERSECTION AND EXPERIENCED AN EXTENDED HOSPITALIZATION.

  Patient problems: Failure to Anastomose

  MAUDE report 23009898 ↗
• MalfunctionSep 9, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PARTIAL COLECTOMY PROCEDURE, INVOLVING THE OPEN STAPLER, THERE WAS A INCOMPLETE STAPLE LINES. THE STAPLE LINES DID NOT MEET UP AS EXPECTED. FULL, COMPLETE SQUEEZES OF THE HANDLE WERE PERFORMED. THE DEVICE WAS REPLACED, AND A SECOND OPEN STAPLER OF THE SAME TYPE WAS EMPLOYED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002329 ↗
• MalfunctionAug 20, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A SMALL BOWEL RESECTION, THE STAPLER MISFIRED. THE STAPLER WAS REPLACED WITH A NEW STAPLER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852483 ↗
• MalfunctionAug 6, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING AN OPEN SMALL BOWEL RESECTION, THE DEVICE MISFIRED. THESE ISSUES RESULTED IN EXTENDED SURGICAL TIME.

  Patient problems: Insufficient Information

  MAUDE report 22724477 ↗
• MalfunctionMay 27, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE OPEN STAPLER DID NOT FIRE. THE STAPLER WAS REPLACED WITH ANOTHER DEVICE 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 22090199 ↗
• MalfunctionMay 23, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, WHEN THE SURGEON FULLY SQUEEZES THE HANDLE, THE STAPLES DID NOT DEPLOY, AND THE TISSUE WAS NOT CUT. THE HANDLE RETURNED TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE. 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 22079458 ↗
• MalfunctionMay 23, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY PROCEDURE, THE RELOADABLE STAPLER DID NOT FIRE AS EXPECTED. THE DEVICE WAS REPLACED 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 22079038 ↗
• MalfunctionMay 20, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE OPEN STAPLER DID NOT FIRE, NECESSITATING THE REPLACEMENT WITH A NEW PRODUCT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050592 ↗
• MalfunctionMay 19, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN EXTENDED RIGHT HEMICOLECTOMY PROCEDURE, THE SURGEON PERFORMED A FULL COMPLETE SQUEEZE OF THE HANDLE, BUT THE STAPLER DID NOT FIRE. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. IT WAS NOTED THAT THE PROCEDURE TIME WAS EXTENDED BY 10 MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048135 ↗

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-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-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-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-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-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-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-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT

…and 58 more.