TA TA30V3LRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884521043152), received between Sep 22, 2017 and Dec 23, 2025 — classified as 1 death, 6 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (21 reports).

1 FDA recall record name this device's identifier.

72 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.

Recalls naming this device

1. Nov 23, 2020Completed

   May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis

   Z-0748-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT INTRAOPERATIVELY, DURING USE OF THE OPEN STAPLER, A STAPLE FORMATION ISSUE OCCURRED, WITH ONLY 70% OF THE STAPLES FIRING. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885558 ↗
• MalfunctionDec 8, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 23751442 ↗
• MalfunctionOct 15, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRIOR TO USE, THE OPEN STAPLER FAILED TO FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298379 ↗
• MalfunctionSep 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE OF THE OPEN STAPLER, THE TWO INSTRUMENT DID NOT FIRE. THE DEVICE WAS REPLACED WITH A NEW RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086462 ↗
• MalfunctionSep 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING USE OF THE OPEN STAPLER, THE TWO INSTRUMENT DID NOT FIRE. THE DEVICE WAS REPLACED WITH A NEW RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086450 ↗
• MalfunctionDec 11, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE INVOLVING THE TWO TA STAPLER LOADING UNITS, THERE WERE FIRING ISSUES THAT RESULTED IN THE STAPLES NOT DEPLOYING. THE TISSUE WAS CUT UNDER THE ASSUMPTION THAT THE STAPLES HAD DEPLOYED, LEADING TO AN EXTENDED SURGICAL TIME OF ALMOST ONE HOUR. IT WAS NOTED THAT THERE WERE NO PINS IN THE RELOAD AFTER THEY FIRED THE GUN. THE ISSUE WAS RESOLVED BY PERFORMING SUTURING AS A STAPLE LINE REPLACEMENT AND THE SAME HANDLE WAS USED WITH THE NEW RELOAD.

  Patient problems: Tissue Breakdown

  MAUDE report 20905853 ↗
• MalfunctionDec 11, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE INVOLVING THE TWO TA STAPLER LOADING UNITS, THERE WERE FIRING ISSUES THAT RESULTED IN THE STAPLES NOT DEPLOYING. THE TISSUE WAS CUT UNDER THE ASSUMPTION THAT THE STAPLES HAD DEPLOYED, LEADING TO AN EXTENDED SURGICAL TIME OF ALMOST ONE HOUR. IT WAS NOTED THAT THERE WERE NO PINS IN THE RELOAD AFTER THEY FIRED THE GUN. THE ISSUE WAS RESOLVED BY PERFORMING SUTURING AS A STAPLE LINE REPLACEMENT AND THE SAME HANDLE WAS USED WITH THE NEW RELOAD.

  Patient problems: Tissue Breakdown

  MAUDE report 20904913 ↗
• InjuryAug 15, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PNEUMONECTOMY, THE STAPLER DID NOT FIRE AND THERE WAS A MASSIVE HEMORRHAGE FROM THE RIGHT MAIN PULMONARY ARTERY RESULTING IN A BLOOD LOSS OF NEARLY 2 LITERS IN LESS THAN A MINUTE AND REQUIRED BLOOD TRANSFUSION. SUTURING WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19991080 ↗
• MalfunctionMar 8, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLE LINE WAS INCOMPLETE.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 18868635 ↗
• MalfunctionDec 19, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359831 ↗
• MalfunctionOct 25, 2023Failure to Fire; Mechanics Altered; Failure to Fire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING OPEN PROCEDURE, THE DEVICE 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 18007467 ↗
• MalfunctionAug 8, 2023Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN KIDNEY TRANSPLANT, POOR STAPLE FORMATION WAS OBSERVED AND STAPLE LINE WAS BLEEDING.

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

  MAUDE report 17481673 ↗
• MalfunctionAug 7, 2023Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476903 ↗
• MalfunctionJan 4, 2023Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN EN BLOC RIB RESECTION, THE DEVICE DID NOT FIRE. THERE WAS AN ACTIVE HEMORRHAGE, BLOOD LOSS OF 500CC OR MORE. THE VESSELS AND BRONCHUS  WERE HAND LIGATED AND THE LUNG WAS OVERSEWED TO RESOLVE THE ISSUE. NO BLOOD PRODUCTS WERE NEEDED. IT WAS STATED THAT THE ISSUE OCCURRED ON THE SUCCEEDING RELOAD. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE AS A RESULT OF THE EVENT.

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

  MAUDE report 16096133 ↗
• MalfunctionDec 14, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN NEPHRECTOMY PROCEDURE, THE HANDLE REMAINED IN THE CLOSED POSITION AFTER THE SECOND SQUEEZE, HENCE THE STAPLER DID NOT FIRE. ANOTHER STAPLER AND RELOAD WERE OPENED AND FIRED CORRECTLY IN ITS PLACE TO FIX THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978741 ↗
• MalfunctionJul 25, 2022Entrapment of Device; Failure to Form Staple; Entrapment of Device; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING VETERINARY OPEN RIGHT MEDIAL LIVER LOBECTOMY, WHEN BEING USED ON LIVER MASS, THE CARTRIDGE WAS STUCK TO THE TISSUE - THE DEPLOYED STAPLES DID NOT FULLY RELEASE FROM THE TISSUE LEADING TO IT REMAINING TIED IN THE PATIENT. HEMOCLIPS WERE APPLIED PROXIMALLY AND CTA'S WERE USED TO RELEASE THE TISSUE FREE. POOR STAPLE FORMATION AND INCOMPLETE STAPLE LINE WAS NOTED EVEN THOUGH HANDLE WAS FULLY SQUEEZED. THIS WAS RESOLVED BY RESECTING AND RE-STAPLING.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15099046 ↗
• DeathJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN EXTENDED PNEUMONECTOMY LEFT PROCEDURE FOR CENTRAL LUNG CARCINOMA ON (B)(6) 2022, WHERE VASCULARISATION WAS PERFORMED WITH STAPLE SUTURE DEVICE, THERE WERE TIGHTNESS PROBLEMS WITH THE STAPLE SUTURE ROW. FIRST, THE PULMONARY ARTERY WAS OCCLUDED WITH THE INSTRUMENT AND SET DOWN, THEN THE PULMONARY VEIN WAS OCCLUDED WITH THE INSTRUMENT INCLUDING A NEW RELOAD AND SET DOWN. THE TIGHTNESS WAS CHECKED AND ENSURED. THE INFERIOR VEIN WAS SUPPLIED EXTRA PERICARDIALLY, THE SUPERIOR PULMONARY VEIN AND THE PULMONARY ARTERY INTRAPERICARDIALLY. IN THE AFTERNOON HOURS OF MAY 17, THE SURGICAL REVISION WAS PERFORMED IN THE CIRCULATORY STABLE PATIENT, WITH SHADOWING IN THE LEFT HEMITHORAX AND 400ML BLOOD IN THE DRAINAGE. THE REVISION REVEALED A COAGULUM WITHOUT EVIDENCE OF A CURRENT SOURCE OF BLEEDING. THE HILAR VESSEL WERE UNREMARKABLE. THE STAPLE LINE LEAKED ON LEFT PULMONARY ARTERY STUMP. WHILE IN THE INTENSIVE CARE UNIT AT APPROXIMATELY 8:30 P.M. ON MAY 17, AFTER A COUGHING EPISODE, THE PATIENT DISCHARGED A MASSIVE AMOUNT OF BLOOD FROM THE DRAINAGE. THE DOCTOR ON DUTY PERFORMED A BEDSIDE RETHORACOTOMY UNDER EMERGENCY CONDITIONS IN THE OPERATING THEATRE.

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

  MAUDE report 14622074 ↗
• MalfunctionApr 7, 2022Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14044999 ↗
• MalfunctionDec 7, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN LOBECTOMY, WHEN TRANSECTING PULMONARY ARTERY, THE DEVICE DID NOT FIRE - FULL COMPLETE SQUEEZE OF THE HANDLE COULD NOT BE PERFORMED. THE RELOAD WAS REPLACED BUT IT DID NOT WORK TOO. THE SURGEON REPLACED THE WHOLE STAPLER SET AND FINISHED THE OPERATION. THE PATIENT HAD NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957984 ↗
• MalfunctionNov 16, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLE OF THE DEVICE DID NOT COME OUT.

  Patient problems: Insufficient Information

  MAUDE report 12821706 ↗
• MalfunctionAug 17, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE ALL THE STAPLES.

  Patient problems: Insufficient Information

  MAUDE report 12333103 ↗
• InjuryAug 8, 2021Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN HEMI-HEPATECTOMY, DURING THE OCCLUSION OF THE HEPATIC VEINS, THERE WAS POOR STAPLE FORMATION. THE STAPLES WERE NOT IN THE NORMAL B-SHAPE. THE VEINS WERE IMMEDIATELY CLAMPED AND OVER SEWED. THE RETAINING PIN DID NOT GET BACK AFTER OPENING THE INSTRUMENT AT THE OPENING KNOB. THE MALFORMED STAPLES ALSO FELL INTO THE PATIENT¿S CAVITY AND WERE RETRIEVED WITH FORCEPS. THE SAME ISSUE OCCURRED WITH 2 MORE RELOADS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12292260 ↗
• InjuryAug 8, 2021Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN HEMI-HEPATECTOMY, DURING THE OCCLUSION OF THE HEPATIC VEINS, HERE WAS POOR STAPLE FORMATION. THE STAPLES WERE NOT IN THE NORMAL B-SHAPE. THE VEINS WERE IMMEDIATELY CLAMPED AND OVER SEWED. THE RETAINING PIN DID NOT GET BACK AFTER OPENING THE INSTRUMENT AT THE OPENING KNOB. THE MALFORMED STAPLES ALSO FELL INTO THE PATIENT¿S CAVITY AND WERE RETRIEVED WITH FORCEPS. THE SAME ISSUE OCCURRED WITH 2 MORE RELOADS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12292259 ↗
• MalfunctionMay 26, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN SURGERY, THE DEVICE WAS UNABLE TO FIRE. ANOTHER 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 11882699 ↗
• MalfunctionMar 16, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DOCTOR CUT AND WENT TO STAPLE, BUT NO STAPLES CAME OUT. THE ANIMAL EXPERIENCED BLEEDING OF SMALL VOLUME OF BLOOD. AFTER THE STAPLER WAS RELEASED AND BLEEDING OCCURRED, BOTH THE PATIENT AND THE MASS WERE RADIOGRAPHED TO CONFIRM THAT THERE WERE NO STAPLES PRESENT. THE HEPATIC VEINS WERE CLAMPED AND LIGATED TO RESOLVE THE ISSUE.

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

  MAUDE report 11499840 ↗

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-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-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-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-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-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-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-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-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT

…and 57 more.