TA TA6035LRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521043206), received between Nov 28, 2017 and Sep 17, 2024 — classified as 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (10 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE EXPLORATIVE LAPAROTOMY, THE STAPLER DID NOT FIRE. THE LOADING UNIT WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236086 ↗
• MalfunctionSep 10, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE ACCOUNT PERFORMED FULL, COMPLETE SQUEEZES OF THE HANDLE, BUT THE STAPLE LINE WAS INCOMPLETE. THE TISSUE WAS RESECTED, AND ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 20179047 ↗
• MalfunctionNov 6, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING COLOSTOMY REVERSAL, BOTH THE PRELOADED CARTRIDGE AND TWO RELOADS WERE UNABLE TO FIRE. THE SURGEON HANDSEWN THE ANASTOMOSIS TO CONTINUE THE CASE. THE EVENT LED TO INSIGNIFICANT AMOUNT OF BLOOD LOSS AND SURGICAL TIME WAS EXTENDED BY AN HOUR.

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

  MAUDE report 18080622 ↗
• MalfunctionAug 23, 2023Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604363 ↗
• MalfunctionApr 17, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, GENERAL SURGERY, THE CARTRIDGE 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 16755526 ↗
• MalfunctionJul 22, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE DEVICE WAS NOT FIRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089307 ↗
• InjuryJul 12, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN LOW ANTERIOR RESECTION (LAR), IN THE COLON, THERE WAS POOR STAPLE FORMATION FOR THE THREE DEVICES. THERE WAS ALSO AN INCOMPLETE STAPLE LINE. TO RESOLVE THE ISSUE, THE SURGEON OVER SEWED THE STAPLE LINE. A TEMPORARY COLOSTOMY WAS DONE AS WELL. THE PROCEDURE WAS EXTENDED FOR MORE THAN THIRTY MINUTES.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 14991010 ↗
• MalfunctionMay 10, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, ONLY HALF OF THE STAPLES FIRED. THE PATIENT DOG PASSED AWAY, BUT THE SURGICAL TEAM WAS NOT SURE IF THIS WAS THE CAUSE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14348938 ↗
• MalfunctionNov 9, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE LOADING UNIT DID NOT FIRE DURING AN OPEN PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780279 ↗
• MalfunctionSep 7, 2021Component Missing; Mechanics Altered; Component Missing; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING VETERINARY RIGHT MEDIAL LIVER LOBECTOMY, AS LIVER LOBE WAS BEING TRANSACTED AWAY FROM THE STAPLER, AFTER CUTTING THE TISSUE, IT WAS DISCOVERED THAT THE DEVICE WAS UNABLE TO FIRE. THERE WERE NO STAPLES ON THE TISSUE NOR THE CARTRIDGE WHEN INSPECTED VISUALLY AND RADIOGRAPHICALLLY. THE TISSUE STARTED TO PULL AWAY AND SIGNIFICATION BLEEDING OF 800CC OCCURRED. THE DOG HAD ARREST WITHIN 5-10 SECONDS OF BLEEDING. SURGICAL TIME WAS EXTENDED BY AT LEAST 30 MINUTES. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PATIENT DIED. THERE WERE NO STAPLES ON THE TISSUE NOR THE CARTRIDGE WHEN INSPECTED VISUALLY AND RADIOGRAPHICALLLY.

  Patient problems: Decreased Peak Expiratory Flow rate; Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 12436023 ↗
• InjuryAug 24, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN COLON RESECTION PROCEDURE, WHEN THE SURGEON WAS CLOSING THE ANASTOMOSIS, BOTH DEVICES DID NOT DEPLOY STAPLES, AND THE SURGEON MADE THE CUT EXPECTING STAPLES TO BE DEPLOYED. TO RESOLVE THE ISSUE SURGEON CLAMPED THE BOWEL AND FIXED THE DAMAGED TISSUE BY HAND SEWING.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12359948 ↗
• MalfunctionMar 10, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRIOR TO USE, STAPLES DID NOT COME OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453062 ↗
• MalfunctionMar 8, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING SIGMOIDECTOMY, WHEN SIGMOID COLON OF ANAL SIDE WAS RESECTED, THE DEVICE DID NOT FIRE. IT WAS SQUEEZED, BUT THERE WAS NO STAPLES HAD BEEN FIRED AND SECOND SQUEEZING HAVE NOT BEEN ABLE TO BE PERFORMED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435765 ↗
• MalfunctionFeb 8, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE, THE DEVICE PARTIALLY FIRED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11293517 ↗
• MalfunctionFeb 8, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE STAPLE DID NOT COME OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11292963 ↗
• InjuryJan 5, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN EXPLORATORY LAPAROTOMY, TUMOR DEBULKING, TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, PARTIAL COLECTOMY, THERE WERE TWO FIRINGS ON THE RECTUM AND ONE ON THE TRANSVERSE COLON, THE TWO RELOADS AND STAPLER PARTIALLY FIRED, THERE WAS POOR STAPLE FORMATION. THE USER OVERSEW THE STAPLE LINE TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11117033 ↗
• InjuryJan 5, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN EXPLORATORY LAPAROTOMY, TUMOR DEBULKING, TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, PARTIAL COLECTOMY, THERE WERE TWO FIRINGS ON THE RECTUM AND ONE ON THE TRANSVERSE COLON, THE TWO RELOADS AND STAPLER PARTIALLY FIRED, THERE WAS POOR STAPLE FORMATION. THE USER OVERSEW THE STAPLE LINE TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11116952 ↗
• MalfunctionSep 8, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING OPEN BILLROTH 1 (B1) PROCEDURE, THE JAWS OF THE STAPLER WAS UNABLE TO CLOSE AND THE LOADING UNIT WAS PARTIALLY FIRED. THE SURGEON USED A NEW STAPLER TO COMPLETE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10504778 ↗
• InjuryJul 31, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING DUODENOPANCREATECTOMIA, THE DEVICE STAPLE WAS NOT ABLE TO DEPLOY. THE SURGEON CUT THE TISSUE THINKING THAT THE STAPLES HAD DEPLOYED. SURGEON DID MANUAL SUTURING TO RESOLVE THE ISSUE.

  Patient problems: Tissue Damage

  MAUDE report 10353451 ↗
• InjuryJul 28, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE PARTIALLY FIRED. IT WAS STATED THAT TWO LOADING UNITS HAD THE SAME MALFUNCTION DURING THE EVENT. OVER SEWING WAS DONE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 10332063 ↗
• MalfunctionMay 22, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED TO DETACH THE GASTRIC BODY PART DURING AN OPEN SUBTOTAL GASTRECTOMY, THE DEVICE DID NOT FIRE. IT WAS ALSO NOTED THAT THERE WAS A PROBLEM WHEN REPLACING THE NEW STAPLE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10081644 ↗
• MalfunctionDec 18, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING CLOSURE OF THE ILEUM ON AN ILEOSTOMY TAKEDOWN, THE SURGEON HAD TO USE EXTREME PRESSURE TO UNCLAMP THE STAPLER FROM THE TISSUE AFTER FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490705 ↗
• MalfunctionApr 30, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN HEPATECTOMY PROCEDURE, WHEN THE DEVICE WAS BEING APPLIED TO THE JEJUNUM, THE SURGEON PERFORMED FULL, COMPLETE SQUEEZES OF THE HANDLE BUT THE DEVICE NOT ABLE TO FIRE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8565559 ↗
• InjuryApr 8, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN EXPLORATORY SMALL BOWEL RESECTION PROCEDURE, WHILE TRANSECTING THE SMALL BOWEL, THE SURGEON WAS ABLE TO COMPLETELY SQUEEZE THE HANDLE AND THE HANDLE RETURN TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE OF THE HANDLE. IT ALSO REMAIN IN THE CLOSED POSITION FOLLOWING THE SECOND COMPLETE SQUEEZE, BUT IT DID NOT FIRE. THIS HAPPENED USING TWO RELOADS WHICH CAUSED TISSUE DAMAGED. BOWEL SECTION 3-5 INCH SECTION WAS UNUSABLE AND HAD TO USE A DIFFERENT SECTION OF BOWEL. ANOTHER RESECTION WAS DONE AND THIS TIME MANUAL STAPLER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8493155 ↗
• InjuryAug 3, 2018Difficult or Delayed Positioning; Failure to Form Staple; Physical Resistance/Sticking; Difficult or Delayed Positioning

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BOWEL RESECTION, WHILE BEING APPLIED TO CREATE ANASTOMOSIS OF THE SMALL BOWEL, THEY NOTICED THE DEVICE FIRED WITH SOME RESISTANCE. AFTER THEY CUT THE SMALL BOWEL, THEY ALSO NOTICED THAT THE STAPLES DID NOT FORM ON PART OF THE BOWEL, WHERE THE ENTIRE STAPLE LINE FELL A PART AND NEARLY ALL THE STAPLES HAD NOT FORMED B SHAPED STAPLES. THEY HAD TO RESECT AND RE-STAPLED TO FIX THE STAPLE LINE. AND IN ORDER TO COMPLETE THE CASE, THEY HAD TO REMOVE ANOTHER CENTIMETER OF SMALL BOWEL, AND OPENED ANOTHER STAPLER TO DO THE ANASTOMOSIS. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 7746840 ↗

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-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-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-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-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-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-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-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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

…and 58 more.