TA TA3048SRecalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10884521043138), received between May 23, 2016 and Aug 4, 2026 — classified as 25 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (31 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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50131516 ↗
• MalfunctionApr 24, 2026Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CLOSURE OF THE LEFT MAIN BRONCHUS USING A GREEN OPEN STAPLER, THE STAPLE LINE DID NOT DEPLOY DESPITE ACTUATING THE STAPLER HANDLE TWICE WITH FULL, COMPLETE SQUEEZES. THE HANDLE RETURNED TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE AND REMAINED IN THE CLOSED POSITION FOLLOWING THE SECOND COMPLETE SQUEEZE, AND THE INSTRUMENT DID NOT FIRE IN THE OPERATIVE FIELD. THE LEFT MAIN BRONCHUS REMAINED WIDELY OPEN WITH THE TIP OF THE ENDOTRACHEAL TUBE VISIBLE IN THE OPERATIVE FIELD, AND THE BRONCHUS WAS CLOSED WITH INTERRUPTED SUTURES AS A STAPLE LINE REPLACEMENT. THE PROCEDURE WAS EXTENDED A FEW MINUTES. THE OPEN STAPLER WAS THEN TESTED OUTSIDE THE OPERATIVE FIELD BY ACTUATING THE HANDLE TWICE, AND STAPLES DEPLOYED; THE INSTRUMENT WAS SET ASIDE.

  Patient problems: Tissue Breakdown

  MAUDE report 24975677 ↗
• MalfunctionDec 16, 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 23820893 ↗
• MalfunctionNov 28, 2025Mechanics Altered; Mechanics Altered

  ACCORDING TO THE CLINICAL STUDY, INTRA-OPERATIVELY, DURING THE USE OF THE STAPLER IN THE RECTUM, NO STAPLES WERE RELEASED FROM THE ROW AT THE SECTION. THE OPERATING STAFF REPORTED THAT NO STAPLES WERE FOUND IN THE STAPLER, IN THE EDGES OF THE RESECTED SECTION, OR IN THE ABDOMINAL CAVITY. A SECOND STAPLER WAS USED, BUT IT ONLY PARTIALLY FUNCTIONED. AS THIS SECOND STAPLING WAS ALSO UNSATISFACTORY, THE SURGICAL STRATEGY HAD TO BE REVISED IN FAVOR OF A MORE COMPLEX PROCEDURE. THE PATIENT HAD TO BE REPOSITIONED. THE OPERATIVE TIME WAS EXTENDED AS A RESULT.

  Patient problems: Tissue Breakdown

  MAUDE report 23669943 ↗
• MalfunctionJul 1, 2025Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371465 ↗
• MalfunctionJun 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE AND THE PLIERS SEEMED TO JAM. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204609 ↗
• MalfunctionJun 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE PROCEDURE THE STAPLER DID NOT FIRE DESPITE FULL, COMPLETE SQUEEZES OF THE HANDLE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126510 ↗
• MalfunctionMar 3, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLER DID NOT FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 21510277 ↗
• MalfunctionJan 6, 2025Failure to Fire; Physical Resistance/Sticking; Failure to Fire; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A GENERAL SURGERY PROCEDURE, A TWO TA STAPLER EXPERIENCED FIRING ISSUES. THE INSTRUMENT DID NOT FIRE DESPITE FULL, COMPLETE SQUEEZES OF THE HANDLE, AND THE HANDLE DID NOT RETURN TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE. THE DEVICE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078666 ↗
• MalfunctionJan 6, 2025Failure to Fire; Physical Resistance/Sticking; Failure to Fire; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A GENERAL SURGERY PROCEDURE, A TWO TA STAPLER EXPERIENCED FIRING ISSUES. THE INSTRUMENT DID NOT FIRE DESPITE FULL, COMPLETE SQUEEZES OF THE HANDLE, AND THE HANDLE DID NOT RETURN TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE. THE DEVICE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078652 ↗
• MalfunctionOct 9, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLES DID NOT DEPLOY. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Tissue Breakdown

  MAUDE report 20410041 ↗
• MalfunctionMar 7, 2024Failure to Align; Failure to Fire; Failure to Align; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE OPEN STAPLER TIP WAS MISALIGNED AND DID NOT FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862645 ↗
• MalfunctionOct 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, AFTER FULLY PRESSING THE DEVICE, IT WAS IMPOSSIBLE TO FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980416 ↗
• MalfunctionOct 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, TO TRANSECT THE RECTUM, THE USER NOTICED THAT THE DEVICE WAS STUCK AND NEVER USED ON THE PATIENT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17979769 ↗
• MalfunctionOct 13, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC VIDEO-ASSISTED THORACIC SURGERY (VATS) PULMONARY UPPER RIGHT LOBECTOMY, DURING RIGHT UPPER LOBE BRONCHOTOMY, THE TISSUE WAS PUT IN THE JAWS AND THE DEVICE WAS TRIED TO BE FIRED, BUT THE HANDLE COULD NOT BE SQUEEZED. THE SURGEON TRIED SEVERAL TIMES WITH NO SUCCESS. A SAME NEW DEVICE WAS TAKEN OUT AND RESECTION WAS PERFORMED WITH NO ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17934335 ↗
• MalfunctionAug 11, 2023Device Difficult to Setup or Prepare; Failure to Align; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Failure to Align; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN COLORECTAL PROCEDURE, AN ISSUE OCCURRED WHILE CUTTING THE RECTUM. THE METAL PIN OF THE STAPLER DID NOT LOCK AS INTENDED AND DID NOT AUTOMATICALLY FIT INTO THE DESIGNATED HOLE. AFTER SUCCESSFULLY INSERTING THE PIN MANUALLY, ANOTHER PROBLEM SURFACED WHEN THE GREEN RELOAD COMPONENT OF THE DEVICE POPPED OUT OF ITS PLACE ON ITS OWN, CAUSING IT TO NOT STAY FIRMLY SECURED AND EVEN WOBBLE BACK SLIGHTLY. TO ADDRESS THIS PROBLEM, ANOTHER DEVICE WAS USED AS AN ALTERNATIVE SOLUTION TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515727 ↗
• MalfunctionJul 13, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE STAPLES DID NOT DEPLOY. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317601 ↗
• MalfunctionJun 2, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, POOR STAPLE FORMATION WAS OBSERVED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17050565 ↗
• MalfunctionDec 8, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ASSISTED LOW ANTERIOR RESECTION, THE STAPLER DID NOT FIRE. A NEW STAPLER WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947073 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON AN OPEN COLECTOMY, DURING COLON RESECTION, THERE WAS COLON LEAKAGE IMMEDIATELY AFTER FIRING FOR RESECTION OF COLON. SUTURING WAS DONE TO FIX THE LEAKAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15374859 ↗
• InjuryMay 16, 2022Failure 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 LOBECTOMY PROCEDURE, WHILE BEING APPLIED ON LUNG LOBAR, THE STAPLE LINE WAS INCOMPLETE AND THE STAPLES FELL INTO THE PATIENT'S CAVITY. THE SURGEON OVER SEWED DUE TO MANUAL SUTURING THE OPEN STAPLE LINE AND THE STAPLES WERE RETRIEVED MANUALLY.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 14408215 ↗
• MalfunctionJan 27, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, 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 13369050 ↗
• MalfunctionNov 11, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A CEPHALIC DUODENOPANCREATECTOMY PROCEDURE, THE STAPLES DID NOT DEPLOY. THE SURGEON WAS ABLE TO PERFORM FULL AND COMPLETE SQUEEZES OF THE HANDLE AND DID NOT CUT THE TISSUE THINKING THAT THE STAPLES DEPLOYED. THE SURGEON USED ANOTHER STAPLER TO COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801363 ↗
• MalfunctionSep 30, 2021Failure to Fire; Failure to Fire

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

  Patient problems: Insufficient Information

  MAUDE report 12556270 ↗
• MalfunctionSep 23, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING RIGHT UPPER LOBECTOMY, TWO STAPLERS WERE UNABLE TO FIRE. ANOTHER STAPLER 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 12519395 ↗

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-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-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-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-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-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT

…and 58 more.