TA TA4548SRecalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 10884521043190), received between Aug 1, 2016 and Sep 22, 2026 — classified as 29 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (52 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 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860071 ↗
• MalfunctionSep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50841832 ↗
• MalfunctionAug 6, 2026Failure to Fire; Component or Accessory Incompatibility

  It was reported that during a donor procedure, the device was not possible to fire and that it seemed as if the magazine did not quite fit into the handle. The handle was used after a little fixing and after switching to an extra magazine. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160888 ↗
• MalfunctionJan 7, 2026Failure to Form Staple; Expulsion

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AT THE MOMENT THE DOCTOR WENT TO REPOSITION THE STAPLER, THE STAPLER INADVERTENTLY FIRED, STAPLING NOTHING. THE FIRED STAPLES DID NOT FORM A PROPER B-SHAPE. THE STAPLES WERE POORLY FORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000139 ↗
• MalfunctionDec 8, 2025Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER INTRA-OPERATIVELY, TWO LOADING UNITS OF THE THORACO-ABDOMINAL STAPLER DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 23739765 ↗
• MalfunctionOct 31, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LOW ANTERIOR RESECTION, WHILE ON RECTUM TRANSECTION, FIRING COULD NOT BE PERFORMED ON THE FIRST AND SECOND ATTEMPTS. THE HANDLE WAS SQUEEZED ALL THE WAY TO THE END AT ONCE BUT THE STAPLE DID NOT COME OUT FOR THE TWO STAPLERS. FIRING WAS SUCCESSFUL ON THE THIRD ATTEMPT (THIRD ITEM), AFTER WHICH SEPARATION WAS CARRIED OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442547 ↗
• MalfunctionOct 31, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LOW ANTERIOR RESECTION, WHILE ON RECTUM TRANSECTION, FIRING COULD NOT BE PERFORMED ON THE FIRST AND SECOND ATTEMPTS. THE HANDLE WAS SQUEEZED ALL THE WAY TO THE END AT ONCE BUT THE STAPLE DID NOT COME OUT FOR THE TWO STAPLERS. FIRING WAS SUCCESSFUL ON THE THIRD ATTEMPT (THIRD ITEM), AFTER WHICH SEPARATION WAS CARRIED OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442504 ↗
• MalfunctionSep 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE; THE INSTRUMENT DID NOT FIRE. THE DOCTOR HAD TO USE THE STAPLER THREE TIMES TO RELEASE THE STAPLES. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938862 ↗
• MalfunctionAug 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING RECTOSIGMOIDECTOMY, THE OPEN STAPLER FAILED TO FIRE. A NEW STAPLER WAS USED TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED BECAUSE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22859054 ↗
• MalfunctionAug 11, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT THE OPEN STAPLER DID NOT RELEASE THE STAPLES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770106 ↗
• MalfunctionJun 18, 2025Failure to Form Staple; Failure to Form Staple

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

  Patient problems: Tissue Breakdown

  MAUDE report 22285321 ↗
• MalfunctionFeb 7, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION(LAR) PROCEDURE, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, ANOTHER STAPLER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337651 ↗
• MalfunctionFeb 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN LAPAROTOMY PROCEDURE, A STAPLER EXPERIENCED FIRING ISSUES AND COULD NOT BE FIRED ON THE COLON. THE HEALTHCARE PROFESSIONAL CONFIRMED THAT FULL, COMPLETE SQUEEZES OF THE HANDLE WERE PERFORMED, AND THE HANDLE RETURNED TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE BUT REMAINED IN THE CLOSED POSITION AFTER THE SECOND SQUEEZE. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED WITH A NEW STAPLER. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312968 ↗
• MalfunctionJan 10, 2025Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  IT WAS REPORTED THAT THERE WERE FIRING ISSUES WITH THE TA4548S TA 45-4.8 RELOADABLE STAPLER DURING A RECTOSIGMOIDECTOMY. THE INSTRUMENT DID NOT FIRE, AND THE STAPLER GOT STUCK WHEN THE STAPLING WAS GOING TO BE DONE, AS THE ROD DID NOT OPEN. IT WAS NOTED THAT FULL, COMPLETE SQUEEZES OF THE HANDLE WERE NOT PERFORMED. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124678 ↗
• MalfunctionNov 21, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE. A NEW OPEN STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 20745911 ↗
• MalfunctionNov 13, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AFTER FIRING, THE DEVICE WAS FIRED BUT IT DID NOT STAPLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679467 ↗
• MalfunctionOct 4, 2024Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE RETAINING PIN WAS DAMAGED. THE RETAINING PIN WOULD NOT GO DOWN. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20366106 ↗
• MalfunctionAug 5, 2024Failure to Form Staple; Failure to Form Staple

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

  Patient problems: Tissue Breakdown

  MAUDE report 19905711 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN END-TO-END ANASTOMOSIS. DURING SURGERY THE STAPLER MISFIRED WHILE TRYING TO CLOSE THE DESCENDING COLON LEAVING THE RECTUM WIDE OPEN. THIS CAUSED SOME CONTAMINATION WHICH WAS CLEANED/IRRIGATED EXTENSIVELY. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED BLOATING, NAUSEA, HERNIA, ADHESIONS, <(>&<)> PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, REVERSAL OF LOOP ILEOSTOMY, CT SCAN, REPAIR OF PARASTOMAL HERNIA, USE OF STAPLER FOR ANASTOMOSIS, ENTEROTOMY CLOSED WITH STAPLER, NG TUBE, TAP BLOCK, HERNIA REPAIR WITH MESH, USE OF ABDOMINAL BINDER, <(>&<)> USE OF JP DRAIN.

  Patient problems: Abdominal Distention; Adhesion(s); Hernia; Nausea; Pain; Unspecified Tissue Injury

  MAUDE report 19863740 ↗
• MalfunctionJul 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL RECTOSIGMOIDECTOMY, THE STAPLER DID NOT FIRE. SUTURING WAS DONE AS A STAPLE LINE REPLACEMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818524 ↗
• MalfunctionJul 3, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A DIGESTIVE SURGERY, WHILE STAPLING THE COLON, THE DEVICE HAD FIRING ISSUES. THE STAPLE LINE WAS INCOMPLETE. THE STAPLER PARTIALLY STAPLED RESULTING IN UNIONS AT THE TREATED PART. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 19666550 ↗
• MalfunctionJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE RELOAD WAS DISCONNECTED. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605443 ↗
• MalfunctionApr 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A COLORECTAL SURGERY, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PERFORM A FULL SQUEEZE OF THE HANDLE, AND THE HANDLE RETURNED TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE. A DEVICE FROM THE COMPETITOR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19156814 ↗
• MalfunctionApr 2, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE FORMATION OF STAPLE WAS INCOMPLETE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021564 ↗
• MalfunctionMar 8, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, A FULL SQUEEZE OF THE HANDLE WAS PERFORMED BUT THE DEVICE DID NOT FIRE.

  Patient problems: Insufficient Information

  MAUDE report 18869299 ↗

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-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-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-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-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-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-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-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-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT

…and 58 more.