TA TA30V3SRecalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 10884521043145), received between Mar 16, 2016 and Apr 27, 2026 — classified as 4 deaths, 17 injuries, 167 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (117 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. How this data works · Data updated Oct 13, 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-0747-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 188 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LIVER TRANSPLANT, THE INSTRUMENT DID NOT FIRE. THE DEVICE WAS REPLACED BY CHANGING TO ANOTHER STAPLER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25007364 ↗
• MalfunctionApr 9, 2026

  TWO TA STAPLERS WITH DST SERIES TECHNOLOGY DID NOT FUNCTION AS EXPECTED. 1. LOT # P5J1221, EXP 08/31/2030. 2. LOT # P5E1152, EXP 04/30/2030.

  Patient problems: Insufficient Information

  MAUDE report 24828325 ↗
• MalfunctionFeb 22, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDLE OF THE STAPLER WAS JAMMED, AND THE DOCTOR WAS UNABLE TO FIRE THE DEVICE IN ANY WAY. A NEW STAPLER WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410991 ↗
• MalfunctionJan 13, 2026Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BOTH STAPLERS FAILED TO FIRE AND HAD A LOCKING FAILURE. 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 24054726 ↗
• MalfunctionJan 13, 2026Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BOTH STAPLERS FAILED TO FIRE AND HAD A LOCKING FAILURE. 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 24054642 ↗
• MalfunctionDec 26, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SURGEON WAS ABLE TO PERFORM FULL, COMPLETE SQUEEZES OF THE HANDLE, BUT THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901330 ↗
• MalfunctionDec 19, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RELOADABLE OPEN STAPLER DID NOT FIRE.

  Patient problems: Insufficient Information

  MAUDE report 23850787 ↗
• MalfunctionDec 19, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLES HAD POOR FORMATION, AND IT WAS NOT LIGATED. THE SAME ISSUE OCCURRED ON THE SECOND OPEN STAPLER. A NEW OPEN STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23849100 ↗
• MalfunctionDec 18, 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 23836894 ↗
• MalfunctionDec 11, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A VETERINARY PROCEDURE, THE STAPLER DID NOT FIRE. THE STAPLER SEEMED STUCK. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 23775159 ↗
• MalfunctionNov 6, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE INSTRUMENT DID NOT FIRE. A NEW DEVICE WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487045 ↗
• MalfunctionNov 5, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476483 ↗
• MalfunctionNov 5, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER PRIOR TO USE, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476409 ↗
• MalfunctionNov 3, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLES HAD POOR FORMATION, AND IT WAS NOT LIGATED. THE SAME ISSUE OCCURRED ON THE SECOND OPEN STAPLER. A NEW OPEN STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23453110 ↗
• MalfunctionOct 19, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VETERINARY ABDOMINAL EXPLORATORY SURGERY, THE OPEN STAPLER DID NOT FIRE. 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 23334125 ↗
• MalfunctionOct 17, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A VETERINARY CASE, ONE STAPLER OUT OF THE PACK OF THREE PARTIAL FIRED, LEAVING HALF OF THE STAPLES STILL IN THE CARTRIDGE. IT WAS NOTED THAT THERE WAS AN IMMEDIATE HEMORRHAGE. ONCE HEMOSTASIS WAS ACHIEVED THE SURGEON EXAMINED THE STAPLER AND NOTED THAT APPROXIMATELY ONE THIRD DID NOT FIRE CORRECTLY. THE SECOND STAPLER WORKED FINE.

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

  MAUDE report 23323119 ↗
• MalfunctionSep 16, 2025Entrapment of Device; Insufficient Device Problem Information; Entrapment of Device; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, IN A VETERINARY LIVER PROCEDURE, TWO STAPLERS WOULD NOT WORK. THE DEVICES WOULD NOT RELEASE THE CARTILAGE. THE STAPLERS WOULD CLICK BUT NOTHING HAPPENED.

  Patient problems: Insufficient Information

  MAUDE report 23061719 ↗
• MalfunctionSep 16, 2025Entrapment of Device; Insufficient Device Problem Information; Entrapment of Device; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, IN A VETERINARY LIVER PROCEDURE, TWO STAPLERS WOULD NOT WORK. THE DEVICES WOULD NOT RELEASE THE CARTILAGE. THE STAPLERS WOULD CLICK BUT NOTHING HAPPENED.

  Patient problems: Insufficient Information

  MAUDE report 23061608 ↗
• MalfunctionSep 8, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A DONOR HEPATECTOMY, WHEN THE SURGEON WAS FIRING THE RIGHT HEPATIC VEIN, THE DISTAL PART OF THE STAPLE LINE WAS NOT PERFECT. THERE WAS A POOR STAPLE FORMATION. THE VEIN HAD SOME BLEEDING, AND THE SURGEON USED A CLIP FOR HEMOSTASIS.

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

  MAUDE report 22992010 ↗
• MalfunctionAug 26, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LUNG RESECTION PROCEDURE, THE STAPLER EXHIBITED POOR STAPLE FORMATION WHILE DETACHING TISSUE. ADDITIONAL SUTURING OF THE INCISION AND OVER SEWING OF THE STAPLE LINE WERE PERFORMED TO ADDRESS THE STAPLE LINE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 22894360 ↗
• MalfunctionAug 7, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PREOPERATIVELY, WHILE TESTING, THE STAPLER DID NOT FIRE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737616 ↗
• MalfunctionJul 25, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DID NOT FIRE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608792 ↗
• MalfunctionJul 22, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE. THE DEVICE WAS REPLACED WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564073 ↗
• MalfunctionJun 23, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN LIGATION LEFT UPPER EXTREMITY BRACHIOBASILIC ARTERIOVENOUS FISTULA PROCEDURE, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW STAPLER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311651 ↗
• MalfunctionJun 12, 2025Defective Device; Failure to Fire

  VASCULAR TA STAPLER DID NOT FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193918 ↗

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-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-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-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-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-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-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-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• 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
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

…and 57 more.