TA TA9048LRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521043268), received between Sep 28, 2017 and Apr 22, 2024 — classified as 1 death, 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE PARTIALLY FIRED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153192 ↗
• MalfunctionFeb 28, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN AN OPEN PROCEDURE, TWO LOADING UNITS PARTIALLY FIRED. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 18803738 ↗
• MalfunctionFeb 28, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN AN OPEN PROCEDURE, TWO LOADING UNITS PARTIALLY FIRED. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 18802788 ↗
• MalfunctionDec 20, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, IN AN OPEN LEWIS-SANTY PROCEDURE, DURING THE STAPLING PHASE ON THE STOMACH, THE SURGEON PERFORMED FULL AND COMPLETE SQUEEZES OF THE HANDLE BUT NO STAPLING WAS PERFORMED. THE STAPLES DID NOT DEPLOY. THE SURGEON CUT THE TISSUE THINKING THAT THE STAPLES HAD DEPLOYED. THE STOMACH WAS OPEN IN THE THORAX AND GASTRIC LIQUID IN THE THORAX. THE SURGEON PERFORMED MANUAL SUTURE IN TWO PLAN. SUTURE WAS USED IN THE MUCOSA, AND ANOTHER TYPE OF SUTURE IN THE SEROSA, TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES DUE TO THE ISSUE. THERE WAS ALSO BLOOD LOSS OF 200CC. DUE TO THE STOMACH FLUID CONTAMINATION DURING THE PROCEDURE, THE PATIENT WAS GIVEN 3 DAYS OF ANTIBIOTIC.

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

  MAUDE report 18369964 ↗
• MalfunctionMay 24, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT FIRE STAPLES.

  Patient problems: Insufficient Information

  MAUDE report 16996919 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON AN OPEN BOWEL PROCEDURE, WHERE A SIDE-TO-END ANASTOMOSIS FROM DESCENDING COLON TO RECTOSIGMOID STUMP WAS PERFORMED, THERE WAS NO EVIDENCE OF LEAK, GOOD PATENCY OF THE ANASTOMOSIS, AND FLOW OF AIR INTO THE PROXIMAL COLON. HOWEVER, ON THE 7TH POST-OPERATIVE DAY, THE PATIENT REQUIRED AN EMERGENCY LAPAROTOMY WHICH IDENTIFIED COMPLETE DISRUPTION OF LARGE BOWEL ANASTOMOSIS. THE SURGEON PERFORMED A TAKEDOWN OF THE LARGE BOWEL ANASTOMOSIS AND A LEFT COLOSTOMY.

  Patient problems: Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 15429441 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A LAPAROSCOPIC BOWEL SURGERY IN WHICH A SIDE-TO-SIDE ILEOSIGMOID ANASTOMOSIS WAS PERFORMED, AND PRIOR TO LEAVING THE OPERATIVE SUITE, THE ANASTOMOSIS WAS CHECKED FOR INTEGRITY AND COMPETENCE AND ALL WERE CORRECT. HOWEVER, TWENTY FIVE DAYS AFTER, THE PATIENT REQUIRED AN EMERGENCY LAPAROTOMY WHICH IDENTIFIED PERITONITIS AND LEAKAGE OF THE ANASTOMOSIS. THE SURGEON PERFORMED A RESECTION OF ANASTOMOSIS AND CREATION OF END ILEOSTOMY.

  Patient problems: Failure to Anastomose; Peritonitis; Unspecified Tissue Injury

  MAUDE report 15418067 ↗
• MalfunctionMay 20, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, ON AN OPEN LOW ANTERIOR RESECTION, WHILE IN THE COLON, THE SURGEON PERFORMED FULL, COMPLETE SQUEEZES OF THE HANDLE BUT NO STAPLES WERE DEPLOYED. THE SURGEON DID NOT CUT THE TISSUE. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463083 ↗
• MalfunctionNov 16, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE STAPLE DID COME OUT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821599 ↗
• InjuryOct 6, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC PARTIAL GASTRECTOMY WHICH WAS CONVERTED INTO OPEN DUE TO THE DEVICE ISSUE, THE STAPLER WAS USED FOR THE PARTIAL STOMACH RESECTION, BUT THE STAPLE LINE WAS INCOMPLETE. THE SURGEON HAD TO REMOVE EXTRA PORTION OF STOMACH AND RE-STAPLE WITH A LINEAR STAPLER TO FIX THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12583594 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY A COLECTOMY PROCEDURE, THE PATIENT RETURNED TO THE OPERATING ROOM AND A SECOND SURGERY REPAIR DUE TO ANASTOMOSIS LEAK. THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES AND MANUAL SUTURING WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 10355385 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS APPLIED TO BOWEL. FOLLOWING HEMICOLECTOMY, AN ANASTOMOSIS LEAK WAS OBSERVED. THE ANASTOMOSIS WAS REINFORCED WITH SUTURES TO COMPLETE THE CASE. THIS RESULTED TO EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES AND EXTENDED PATIENT HOSPITALIZATION.

  Patient problems: Bowel Perforation; Failure to Anastomose; No Code Available

  MAUDE report 10355300 ↗
• InjuryMar 10, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, WHEN GASTRIC STAPLING ON AN OPEN GASTRECTOMY, THERE WAS AN INCOMPLETE STAPLE LINE. IT WAS CONFIRMED THAT BOTH STAPLER AND REPLACEMENT LOADING UNIT HAD THE SAME MALFUNCTION. THE SURGEON OVERSEW THE STAPLE LINE.

  Patient problems: No Code Available

  MAUDE report 9811130 ↗
• InjuryFeb 2, 2020Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ESOPHAGUS RESECTION, THERE WAS A POOR STAPLE FORMATION. THE STAPLES WERE NOT FORMED CORRECTLY. THEY WERE NOT CLOSED. THE STAPLE LINE WAS INCOMPLETE. THEY RELOADED THE STAPLER, BUT THE SECOND STAPLE LINE WAS ALSO INCOMPLETE AND THE STAPLES WERE MALFORMED. STAPLES FELL INTO THE CAVITY AND WERE ALL RETRIEVED. THEY OVERSEW TO FIX THE STAPLE LINE. THE PROCEDURE WAS EXTENDED BY ONE HOUR MORE.

  Patient problems: No Code Available

  MAUDE report 9656927 ↗
• MalfunctionDec 10, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A ILEOCOLECTOMY COLON RESECTION PROCEDURE, THE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9445297 ↗
• MalfunctionSep 6, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMICOLECTOMY PROCEDURE, WHILE DOING BOWEL ANASTOMOSIS THE DEVICE WAS USED BUT IT DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8972954 ↗
• InjuryApr 23, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE STAPLES OF THE TWO DEVICES DID NOT DEPLOY. THE HANDLES RETURNED TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE OF THE HANDLE. THE HANDLES REMAINED IN CLOSED POSITION FOLLOWING THE SECOND COMPLETE SQUEEZE.

  Patient problems: No Information

  MAUDE report 8540397 ↗
• MalfunctionFeb 28, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLES STAYED BLOCKED IN THE RELOAD AND THIS CONTINUED, EVEN AFTER CHANGE OF THE RELOADS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8380087 ↗
• InjuryJan 29, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A COLON RESECTION A DECISION WAS MADE TO PERFORM A SEGMENTAL L RESECTION, RATHER THAN EXTEND RIGHT HEMICOLECTOMY AS DISCUSSED WITH THE PATIENT, THE FUNCTIONAL END TO END ANASTOMOSIS BETWEEN THE TRAVERSE COLON WITH BOTH DEVICE, HOWEVER THE DEVICES DID NOT FIRE AND THE ANASTOMOSIS WAS SUTURED INSTEAD.

  Patient problems: No Code Available

  MAUDE report 8285747 ↗
• DeathSep 28, 2017Misfire; Misfire

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN THORACOTOMY PROCEDURE. FORTY PERCENT OF THE STAPLERS WERE FIRED. THE STAPLER PARTIALLY FIRED. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, USED ANOTHER RELOAD. THE PATIENT EXPIRED DURING THE CASE.

  Patient problems: Death

  MAUDE report 6900767 ↗

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-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-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-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-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-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-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-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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

…and 58 more.