TA TA6035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 196 adverse event reports that list this exact device (DI 10884521043213), received between Feb 14, 2016 and Jul 2, 2026 — classified as 1 death, 46 injuries, 149 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (88 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 196 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN BOWEL RESECTION, AFTER FIRING THE STAPLER, THE TISSUE DID NOT PROPERLY APPROXIMATE TO CLOSE THE BOWEL. THE SURGEON HAD VISUAL INDICATION THAT THE STAPLE LINE DID NOT FORM APPROPRIATELY AND THAT THE STAPLES WERE MALFORMED. THE SURGEON ELECTED TO RESECT THE AFFECTED STAPLE LINE CONTAINING THE MALFORMED STAPLES AND ENTEROTOMY. HAND SEWING WAS PERFORMED TO CLOSED THE BOWEL.

  Patient problems: Tissue Breakdown

  MAUDE report 25693187 ↗
• MalfunctionJun 30, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A SMALL BOWEL MASS REMOVAL AND BOWEL RESECTION, THE STAPLER MISFIRED WITH THE ORIGINAL LOAD AND AN ADDITIONAL RELOAD, WHICH CAUSED A HOLE IN THE BOWEL. ADDITIONAL BOWEL PIECE APPROXIMATELY 1.5 INCHES HAD TO BE RESECTED BECAUSE OF THIS ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 25665674 ↗
• MalfunctionMay 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, IN SKIN CLOSURE, THERE WAS A TRANSVERSE LINE OF THE SIDE TO SIDE STAPLE FAILURE. THIS ISSUE OCCURRED ON TWO DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 25237390 ↗
• MalfunctionMay 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, IN SKIN CLOSURE, THERE WAS A TRANSVERSE LINE OF THE SIDE TO SIDE STAPLE FAILURE. THIS ISSUE OCCURRED ON TWO DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 25237376 ↗
• MalfunctionMay 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, IN SKIN CLOSURE, THERE WAS A TRANSVERSE LINE OF THE SIDE TO SIDE STAPLE FAILURE. THIS ISSUE OCCURRED ON TWO DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 25237355 ↗
• MalfunctionMay 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, IN SKIN CLOSURE, THERE WAS A TRANSVERSE LINE OF THE SIDE TO SIDE STAPLE FAILURE. THIS ISSUE OCCURRED ON TWO DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 25237328 ↗
• MalfunctionMay 20, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE CLOSURE OF GASTROCUTANEOUS FISTULA, THE SURGICAL TEAM WAS UNABLE TO FIRE AND DEPLOY THE STAPLES. IT WAS NOTED THAT THE STAPLER GOT STUCK. MULTIPLE ATTEMPTS WERE TRIED BUT WITH NO SUCCESS. A NEW STAPLER WAS OPENED AND HAD NO ISSUES. A SURGICAL DELAY OF NO MORE THAN 30 MINUTES OCCURRED WHILE WAITING FOR THE NEW EQUIPMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234141 ↗
• MalfunctionMay 6, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, IN SKIN CLOSURE, THERE WAS A TRANSVERSE LINE OF THE SIDE TO SIDE STAPLE FAILURE. THIS ISSUE OCCURRED ON TWO DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 25099792 ↗
• MalfunctionMay 6, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, IN SKIN CLOSURE, THERE WAS A TRANSVERSE LINE OF THE SIDE TO SIDE STAPLE FAILURE. THIS ISSUE OCCURRED ON TWO DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 25099489 ↗
• MalfunctionDec 22, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863006 ↗
• MalfunctionDec 17, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE OPEN STAPLER DID NOT FIRE TWICE. THE DOCTOR PROCEEDED AND DID NOT USE THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 23825270 ↗
• MalfunctionDec 12, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC RIGHT COLECTOMY, DURING THE CLOSURE OF ENTEROTOMY OF SIDE-TO-SIDE ANASTOMOSIS, THE STAPLE LINE WAS INCOMPLETE. SUTURING WAS DONE AS STAPLE LINE REPLACEMENT TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23794203 ↗
• MalfunctionOct 15, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLE LINE WAS INCOMPLETE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23299473 ↗
• MalfunctionOct 14, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN EX LAP BOWEL RESECTION, SPECIFICALLY WHILE CLOSING A COLOTOMY, THE STAPLES DID NOT DEPLOY. THE DEVICE WAS REPLACED WITH ANOTHER STAPLER.

  Patient problems: Tissue Breakdown

  MAUDE report 23276057 ↗
• MalfunctionAug 25, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE STAPLER WAS FIRED RESULTING IN ONLY THE INNER AND OUTER STAPLES FIRING WHILE THE MIDDLE STAPLES DID NOT, LEAVING THE STAPLE LINE OPEN IN THE MIDDLE. THIS LED TO AN INCOMPLETE STAPLE LINE AND EXTENDED SURGICAL TIME. TO RESOLVE THE ISSUE, ANOTHER LINEAR STAPLER WAS USED TO COMPLETE THE STAPLE LINE WITHOUT FURTHER PROBLEMS.

  Patient problems: Insufficient Information

  MAUDE report 22890306 ↗
• MalfunctionAug 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE INSTRUMENT DID NOT FIRE. THE STAPLER FAILED TO STAPLE.

  Patient problems: Insufficient Information

  MAUDE report 22867901 ↗
• MalfunctionAug 21, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION, IN CLOSURE OF A COMMON ENTEROTOMY, AFTER SQUEEZING THE HANDLE QUICKLY, THERE WERE STAPLES FORMATION ISSUE WITH THE STAPLES DEPLOYING DURING THE FIRST SQUEEZE. THE PROCEDURE WAS EXTENDED BY ONE HOUR, AND THE CLOSURE OF THE COMMON ENTEROTOMY HAD TO BE REDONE. ANOTHER STAPLER WAS USED AND FIRED CORRECTLY TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 22863595 ↗
• MalfunctionJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD ANASTOMOTIC LEAKS.

  Patient problems: Failure to Anastomose; Insufficient Information

  MAUDE report 22608569 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 12 DAYS AFTER SURGERY ON A LAPAROSCOPIC RIGHT HEMICOLECTOMY, AN ANASTOMOTIC LEAKAGE OCCURRED. IT WAS NOTED THAT TEN RELOADS WERE USED AND HAD THE SAME ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 22584927 ↗
• MalfunctionJul 22, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE AFTER A FIRING ATTEMPT, THE DEVICE DID NOT WORK. SUTURING WAS PERFORMED AS A REPLACEMENT FOR THE STAPLE LINE. ANOTHER PRODUCT 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 22563637 ↗
• MalfunctionJul 9, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A CYSTECTOMY, THE OPEN RELOADABLE STAPLER DID NOT FIRE AND WAS IMPOSSIBLE TO USE. THE SURGEON REPLACED THE DEVICE WITH ANOTHER HANDLE FROM THE SAME BATCH. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22455783 ↗
• MalfunctionJul 3, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A BOWEL RESECTION, THE STAPLER FAILED TO FIRE AND WHEN PRESSING THE HANDLE, THE REQUIRED CLICKS DID NOT HAPPEN. ANOTHER STAPLER WAS OPENED AND USED WITH NO ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394242 ↗
• MalfunctionJul 1, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN ISSUE WITH THE CLIP APPLIER AND THE OPEN STAPLER DEVICE DID NOT FIRE. A DIFFERENT STAPLER AND CLIP APPLIER WAS BROUGHT IN TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22371509 ↗
• MalfunctionJun 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRIOR TO USE, THE TWO OPEN STAPLERS DID NOT FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201727 ↗
• MalfunctionJun 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRIOR TO USE, THE TWO OPEN STAPLERS DID NOT FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201693 ↗

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-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-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-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-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-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-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-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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

…and 58 more.