TA TA6048SRecalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 10884521043237), received between May 8, 2017 and Sep 23, 2026 — classified as 1 death, 35 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (43 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 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Adverse Event Without Identified Device or Use Problem

  According to the reporter, intra-operatively, after firing, the staple line did not hold. Another device was used to resolve the issue.

  Patient problems: Tissue Breakdown

  MAUDE report 50871752 ↗
• MalfunctionSep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50860252 ↗
• MalfunctionSep 18, 2026Difficult to Remove; Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820682 ↗
• MalfunctionAug 6, 2026Noise, Audible

  Patient problems: Tissue Breakdown

  MAUDE report 50166036 ↗
• MalfunctionFeb 23, 2026Failure to Form Staple; Firing Problem; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING A ROBOTIC COLOSTOMY REVERSAL THAT WAS CONVERTED TO OPEN DUE TO ADHESIONS, DURING RECTUM TRANSECTION BEFORE FIRING OF THE CIRCULAR STAPLER, THE STAPLES DEPLOYED, BUT IT DID NOT FORM AROUND THE TISSUE. IT CAN BE SEEN THAT THE STAPLES WERE POKING THROUGH THE RELOAD. THE SURGEON WAS UNSURE IF THE LEVER WAS PULLED THE SECOND TIME TO FIRE OR IF IT PULLED BACK AND LOCKED IN PLACE. THE SURGEON ALLUDED TO ITS CLOSING, AND THEN WHEN IT WAS FIRED, IT FELT STUCK. THE STAPLER COULD NOT BE SQUEEZED BACK TO THE HANDLE AND LOCKED INTO PLACE TO SIT FLUSH WITH THE BACK OF THE OPEN STAPLER. THE ISSUE WAS RESOLVED BY RESECTING AND RE-STAPLING THE TISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24413954 ↗
• MalfunctionNov 16, 2025Entrapment of Device; Expulsion; Entrapment of Device; Expulsion

  IT WAS REPORTED THAT DURING AN ABDOMINAL RECTOSIGMOIDECTOMY, UPON ACTIVATING THE STAPLER, THERE WAS TEARING AND INJURING THE INTESTINAL LOOP BEING STAPLED. THE STAPLES WERE EXPOSED AND THEREFORE, STAPLED INCORRECTLY. THE DEVICE WAS REPLACED WITH ANOTHER STAPLER FROM THE SAME BATCH.

  Patient problems: Tissue Breakdown

  MAUDE report 23565838 ↗
• MalfunctionNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE OPEN STAPLER, THE STAPLE LINE DID NOT HOLD AND THE STAPLE LINE OPENED UP AFTER FIRING. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23529112 ↗
• MalfunctionNov 3, 2025Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING LEFT COLECTOMY, INVOLVING THE OPEN STAPLER , THE TISSUE WAS NOT CUT AND STAPLE LINE BLEEDING OCCURRED. THE SURGEON HAD TO RESECT AND RE-STAPLE WITH A MANUAL STAPLER.

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

  MAUDE report 23460448 ↗
• MalfunctionAug 14, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE RIGHT HEMICOLECTOMY VIA LAPAROTOMY, SOME OF THE STAPLES IN THE CARTRIDGE DID NOT CLOSE. ANOTHER OPEN STAPLER AND A CIRCULAR STAPLER WERE REOPENED. REDOING THE ANASTOMOSIS WAS DONE TO RESOLVE THE ISSUE, RESULTING IN AN INCREASED OPERATIVE TIME OF ONE HOUR.

  Patient problems: Failure to Anastomose

  MAUDE report 22808920 ↗
• MalfunctionJul 24, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING USE OF THE STAPLER, THE STAPLES WERE MISSING FROM THE MACHINE. THE PROCEDURE WAS FINISHED WITH HAND STITCHES DUE TO THE DEVICE ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 22585977 ↗
• MalfunctionMay 28, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, THERE WAS AN INCOMPLETE STAPLE LINE, WHICH EXTENDED THE SURGICAL TIME BY 30 MINUTES. THE ISSUE WAS RESOLVED BY RESECTING AND RE-STAPLING. THE PRODUCT WAS REPLACED BY ANOTHER DEVICE.

  Patient problems: Tissue Breakdown

  MAUDE report 22101823 ↗
• MalfunctionFeb 3, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS NO STAPLE LEFT, BECAUSE THE LOAD ONLY HAD A STAPLE HALFWAY THROUGH. THE SURGEON WAS ABLE TO COMPLETE FULL SQUEEZES OF THE HANDLE. SUTURING WAS DONE AS A STAPLE LINE REPLACEMENT AND TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 21299962 ↗
• MalfunctionJul 15, 2024Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING LOBECTOMY, ON THE LUNGS, THERE WAS NO STAPLE IN THE RELOAD. A NEW STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Tissue Breakdown

  MAUDE report 19740690 ↗
• MalfunctionJun 18, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ILEOCOLIC RESECTION PROCEDURE, WHILE STAPLING THE COLON PRIOR TO ANASTOMOSIS, THE STAPLE LINE WAS INCOMPLETE AND THE STAPLES THAT DID NOT FIRE LEFT PIERCINGS IN THE LUMEN. THE SURGEON RELOADED THE STAPLER, RESECTED THE TISSUE, AND FIRED THE SECOND FIRING PROXIMAL TO ORIGINAL FIRING.

  Patient problems: Tissue Breakdown

  MAUDE report 19559997 ↗
• MalfunctionMay 20, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SUBTOTAL COLECTOMY, WHEN STAPLING THE RECTUM, THE DEVICE PARTIALLY FIRED. A NEW STAPLER FROM ANOTHER MANUFACTURER WAS USED TO SEAL THE OPEN LUMEN OF THE RECTUM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354183 ↗
• MalfunctionMay 10, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SIGMOID COLON SURGERY, THE STAPLERS DID NOT DEPLOY AND THE CLIPS WERE UNABLE TO LOAD PROPERLY INTO THE JAWS. IT WAS REPLACED WITH ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19292919 ↗
• MalfunctionApr 23, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLER 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 19165904 ↗
• MalfunctionApr 2, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE HANDLE WAS SQUEEZED BUT THE STAPLER DID NOT FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020443 ↗
• MalfunctionDec 18, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE WAS INOPERATIVE DURING THE SECOND CARTRIDGE LOAD. THE STAPLES DID NOT DEPLOY.

  Patient problems: Insufficient Information

  MAUDE report 18347730 ↗
• MalfunctionDec 1, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SURGEON WAS ABLE TO PERFORM FULL, COMPLETE SQUEEZES OF THE HANDLE BUT THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247537 ↗
• MalfunctionNov 10, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN SIGMOID RESECTION, WHILE IN THE COLON, THE SURGEON FIRED THE STAPLER, BUT DID NOT SEE THE STAPLE LINE. ALL PUSHERS WERE OUT AND THERE WERE A FEW STAPLES ON THE MAYO STAND AFTERWARD. SURGEON HAD TO RESECT AND FIRE ANOTHER STAPLE LOAD BECAUSE THE STAPLES DID NOT DEPLOY. PATIENT LOST ADDITIONAL COLON PERMANENTLY.

  Patient problems: Tissue Breakdown

  MAUDE report 18114021 ↗
• MalfunctionOct 20, 2023No Device Output; Failure to Fire; No Device Output; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PANCREATODUODENECTOMY, DURING RESECTION OF PANCREATIC HEAD LESION, DURING USE OF THE FIRST STAPLER, THE SURGEON FELT THAT THE DEVICE DID NOT SQUEEZE SUFFICIENTLY AND THE DEVICE DID NOT FIRE. THE SECOND DEVICE WAS SQUEEZED FIRMLY BUT THE STAPLES DID NOT PROPERLY FORM THE B-SHAPE AND IT PARTIALLY FIRED. A MANUAL STAPLER WAS USED FOR ADDITIONAL RESECTION AT THE UNSTAPLED SITE AND THERE WAS AN EXTENDED INCISION LESS THAN ONE INCH DUE TO THE POSITION OF THE TUMOR RESECTION WHERE IT WAS DIFFICULT TO ALLOW MARGINS. A MANUAL STAPLER ENSURED THAT THERE WAS A CUTTING ALLOWANCE HENCE RESULTING ON EXPANDED INCISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981386 ↗
• MalfunctionOct 10, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PANCREATODUODENECTOMY, DURING RESECTION OF PANCREATIC HEAD LESION, DURING USE OF THE FIRST STAPLER, THE SURGEON FELT THAT THE DEVICE DID NOT SQUEEZE SUFFICIENTLY AND THE DEVICE DID NOT FIRE. THE SECOND DEVICE WAS SQUEEZED FIRMLY BUT THE STAPLES DID NOT PROPERLY FORM THE B-SHAPE AND IT PARTIALLY FIRED. A MANUAL STAPLER WAS USED FOR ADDITIONAL RESECTION AT THE UNSTAPLED SITE AND THERE WAS AN EXTENDED INCISION LESS THAN ONE INCH DUE TO THE POSITION OF THE TUMOR RESECTION WHERE IT WAS DIFFICULT TO ALLOW MARGINS. A MANUAL STAPLER ENSURED THAT THERE WAS A CUTTING ALLOWANCE HENCE RESULTING ON EXPANDED INCISION.

  Patient problems: Tissue Breakdown

  MAUDE report 17908268 ↗
• MalfunctionSep 18, 2023Failure to Align; Failure to Form Staple; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Failure to Align; Failure to Form Staple; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN LOW ANTERIOR RESECTION (LAR), WHEN THE STAPLER WAS FIRED, IT WAS NOTICED THAT THE GUIDE PIN DID NOT ENGAGE CORRECTLY AND THE STAPLE LINE DID NOT FULLY FORM. THE STAPLES WERE IN SOME INSTANCES WERE NOT COMPRESSED AND STILL IN THE "GOALPOST" SHAPE. UNFORMED STAPLES FELL INTO THE PATIENT'S CAVITY, AND LOOSE STAPLES WERE INITIALLY RETRIEVED USING FORCEPS.IT WAS NOTED THAT ALL COMPONENTS WERE SUCCESSFULLY RETRIEVED. AS A RESULT, THE ANASTOMOSIS WAS FAILED AND THE INCISION WAS EXTENDED MORE THAN AN INCH. TO RESOLVE THE ISSUE, FURTHER RESECTION OF COLON RE ANASTOMOSIS WAS PERFORMED. THE SURGICAL TIME WAS EXTENDED 30MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 17765527 ↗
• MalfunctionMay 23, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A EXPLORATORY LAPAROTOMY, WHEN STAPLING THE BOWEL, THE DEVICE MISFIRED. THE STAPLE-LINE WAS OVERSEWED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16984998 ↗

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-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-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-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-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-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-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-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT

…and 58 more.