TA TA9035LRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521043244), received between Apr 19, 2019 and Jun 4, 2026 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COMPREHENSIVE RESECTION OF A RIGHT RETROPERITONEAL SARCOMA WITH RIGHT NEPHRECTOMY AND RIGHT HEMICOLECTOMY, A BLUE RELOAD USED WITH A RELOADABLE STAPLER FAILED TO FULLY SEAL THE ANASTOMOSIS, RESULTING IN AN INTRAOPERATIVE ANASTOMOTIC LEAK. STAPLE FORMATION ISSUES AND STAPLE LINE BLEEDING AFTER FIRING WERE ALSO REPORTED. A NEW HANDLE AND RELOAD WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 25402619 ↗
• MalfunctionJul 2, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE DEVICE EXPERIENCED A STAPLE FORMATION ISSUE. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT.

  Patient problems: Tissue Breakdown

  MAUDE report 22390650 ↗
• MalfunctionApr 23, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, OPEN PROCEDURE, THE RELOAD DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163654 ↗
• MalfunctionFeb 28, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE PARTIALLY FIRED. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 18803669 ↗
• MalfunctionNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN COLORECTAL SURGERY, AN ANASTOMOTIC LEAK OCCURRED.

  Patient problems: Bowel Perforation; Failure to Anastomose

  MAUDE report 18081037 ↗
• MalfunctionSep 11, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE PARTIALLY FIRED. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719096 ↗
• MalfunctionMar 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN SIGMOID COLECTOMY, THE TWO DEVICE MISFIRED AND DID NOT DEPLOY ANY STAPLES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16574223 ↗
• InjuryJul 29, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN RESTORATION OF INTESTINAL CONTINUITY, WHEN SURGEON WAS MAKING AN ANASTOMOSIS BETWEEN THE ILEUM AND COLON, THE STAPLER WAS PLACED WITH A BLUE RELOAD ACROSS THE ILEUM AND COLON, THE HANDLE CLOSED ON THE FIRST SQUEEZE, RETURNED TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZED OF THE HANDLE AND THEN WAS CLOSED THE SECOND TIME TO COMPLETE THE FIRING AND THE HANDLE REMAINED IN THE CLOSED POSITION. THE SURGEON TRANSECTED ACROSS CORRECT SIDE STAPLER AND BOWEL SLIPPED OUT OF JAWS AS THERE WERE NO STAPLES PRESENT AT ALL. THERE WAS TWO INCHES EXTRA OF BOWEL THAT NEEDED TO BE REMOVED AND THEN THE SURGEON HAD TO REDO THE ANASTOMOSIS WITH ANOTHER STAPLER AND LOADING UNIT. THE LENGTH OF THE SURGERY TIME WAS EXTENDED BY AT LEAST 45 MINUTES. TISSUE DAMAGE AND UNANTICIPATED TISSUE LOSS WERE NOTED. THE SURGEON WAS UNSURE WHETHER THE PATIENT WILL HAVE AN EXTENDED HOSPITAL STAY DUE TO THIS ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 15135110 ↗
• MalfunctionJun 9, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. A NEW PRODUCT EXCHANGED WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14648871 ↗
• MalfunctionJun 9, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE STAPLER DID NOT FIRE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645280 ↗
• InjuryApr 21, 2022Mechanics Altered; Insufficient Device Problem Information; Mechanics Altered; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN OPEN RIGHT HEMICOLECTOMY PROCEDURE, WHILE IN LARGE BOWEL, THE FIRST STAPLE RELOAD DID NOT FIRE PROPERLY. THE STAPLES WERE NOT FORMED AND WERE STILL IN THE RELOAD. THE ANASTOMOSIS WAS REQUIRED TO BE DONE AGAIN WHICH EXTENDED THE SURGICAL TIME FOR 30 MINUTES OR MORE. ANOTHER RELOAD WAS USED AND FIRED WITHOUT INCIDENT THAT COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Insufficient Information

  MAUDE report 14168145 ↗
• MalfunctionNov 9, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN SURGERY, THE TWO LOADING UNITS WERE UNABLE TO FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780089 ↗
• MalfunctionNov 9, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN SURGERY, THE DEVICE WAS UNABLE TO FIRE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779030 ↗
• MalfunctionMay 25, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876772 ↗
• MalfunctionMay 24, 2021Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872155 ↗
• InjuryJun 24, 2020Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, WHEN CLOSING OF THE OPEN WOUND OF THE ANASTOMOSIS DURING HEMICOLECTOMY SIDE-TO-SIDE ANASTOMOSIS, THE DEVICE DID NOT FIRE. THE SURGEON HAD TO SEW THE OPEN WOUND. THIS RESULTED TO EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES. THERE WAS UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM. THE SAME EVENT OCCURRED ON TWO UNITS OF THE DEVICE. THE SURGEON ALSO NOTICED THAT THE TIP OF THE STAPLES POINTING OUTSIDE THE CARTRIDGE.

  Patient problems: No Code Available

  MAUDE report 10191035 ↗
• MalfunctionMay 29, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING OPEN LEFT HEMICOLECTOMY, UPON STAPLING LEFT HEMI COLON, THE DISTAL PART OF STAPLE FORMATION WAS NOT B SHAPE. THE DEVICE WAS CHANGED TO ANOTHER PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10100760 ↗
• InjuryAug 7, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, WHEN THE STAPLER WAS BEING FIRED ACROSS THE LARGE COLON ON AN OPEN BOWEL RESECTION, A 3.5MM RELOAD WAS USED WITH A 4.8MM HANDLE BUT STAPLES DID NOT DEPLOY ON THE FIRST FIRING. THE TISSUE WAS CUT THINKING THAT THE STAPLES WERE DEPLOYED. ANOTHER 3.5MM RELOAD WAS USED ON THE SAME HANDLE BUT DID NOT DEPLOY STAPLES EITHER. CLAMPS WERE PUT ACROSS THE OPEN WOUND TO TEMPORARILY CLOSE THE OPENING AND THE STAPLER WAS RELOADED WITH ANOTHER RELOAD. THE SURGEON REMOVED THE CLAMPS AND FIRED THE STAPLER ACROSS THE BOWEL. THIS TIME, THE SURGEON DID NOT CUT ANY EXTRANEOUS TISSUE OFF BEFORE OPENING THE STAPLER. THE SURGEON OPENED ANOTHER 4.8MM HANDLE AND ANOTHER 3.5MM RELOAD AND EVERYTHING WORKED FINE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8872127 ↗
• MalfunctionApr 19, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE WAS FIRED SUCCESSFULLY, BUT PIN DID NOT LINE UP AND CAUSED MISFIRE WHEN THEY PUT ON THE LISTED ADDITIONAL RELOAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531710 ↗

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-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-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-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-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-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-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

…and 58 more.