TA TA6048LRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10884521043220), received between Oct 10, 2017 and Apr 1, 2026 — classified as 14 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (9 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STAPLE LINE DID NOT HOLD AND OPENED UP AFTER FIRING FOR THE TWO LOADING UNITS. IT WAS NOTED THAT THE STAPLER WAS WELL USED AND THE ADDITIONAL CARTRIDGES THAT HAD THE PROBLEM. THE DEVICE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24760645 ↗
• MalfunctionJan 28, 2025Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PRIOR TO FIRING, THE PIN CANNOT BE ADVANCED. IT WAS NOTED THAT THE STAPLER DID NOT USE ON PATIENT AT ALL. A NEW STAPLER AND RELOAD WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252745 ↗
• MalfunctionAug 20, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006049 ↗
• MalfunctionJul 17, 2024Mechanics Altered; Mechanics Altered

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763714 ↗
• MalfunctionJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, WHEN DISSECTING THE RECTUM, ON BOTH RELOAD, THE COMPONENT DISENGAGED. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059976 ↗
• MalfunctionJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, WHEN DISSECTING THE RECTUM, ON BOTH RELOADS, THE COMPONENT DISENGAGED. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059823 ↗
• MalfunctionMay 15, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN PARTIAL GASTRECTOMY LYSIS OF ADHESION, EPIGASTRIC HERNIA REPAIR, STAPLING RESECTION OF THE STOMACH, THE DEVICE PARTIALLY FIRED. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929834 ↗
• MalfunctionMay 10, 2023Detachment of Device or Device Component; Expulsion; Detachment of Device or Device Component; Expulsion

  ACCORDING TO THE REPORTER, DURING AN OPEN COLECTOMY, THE STAPLES WERE EXPOSED OUT OF THE RELOAD CARTRIDGES, STRAIGHT OUT OF THE PACKAGING. A FEW MORE RELOADS WERE GRABBED AND NOTICED WHEN FIRED OFF THE BACK TABLE THAT THE PUSHERS DID NOT ALL GET EXPOSED AND OPEN STAPLE LEGS FELL OUT. A NEW STAPLER AND LOADING UNIT FROM DIFFERENT LOT WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904018 ↗
• InjuryNov 23, 2022Failure to Align; Adverse Event Without Identified Device or Use Problem; Failure to Align; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A COLON SIGMOID RESECTION APPENDECTOMY, TWO RELOADS WERE USED. ONE HAD MALFORMED STAPLES WHILE THE OTHER ONE HAD ITS PIN MISALIGNED. THE SURGEON HAD TO OVER SEW THE ANASTOMOSIS.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15855093 ↗
• InjuryAug 20, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE LOWER ANTERIOR RESECTION, AFTER FIRING THE STAPLER AT RECTOSIGMOID JUNCTION, THERE WAS IMPROPER STAPLE LINE. A SMALL AMOUNT OF BLEED CAUSE AT THE STAPLE LINE AND ALSO AIR GAP IS FORMED BETWEEN PIN. THIS CAUSED THE FLOW OF DIGESTED FOOD TO FLOW UPWARDS AND HAD ADVERSE EFFECTS. RE-EXPLORATION AND ILEOSTOMY PROCEDURE WAS PERFORMED TO FIX THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Unspecified Tissue Injury

  MAUDE report 15263045 ↗
• InjuryJun 27, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHILE THE STAPLER USED AT RECTUM DURING AN OPEN LOW ANTERIOR RESECTION PROCEDURE, DEVICE PERFECTLY FIRED BUT DUE TO POOR STAPLE LINE, BLEEDING HAPPENS FROM STAPLE LINE. SURGEON USED SUTURES TO OVERSEW THE STAPLE LINE TO STOP THE BLEEDING. EXTENSION OF THE HOSPITAL STAY FOR 5 DAYS ANG COUNTING, EXTRA SUTURES COST, AND EXTENDED ANESTHESIA TIME OCCURRED DUE TO DEVICE PROBLEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14836732 ↗
• MalfunctionJun 9, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645267 ↗
• InjuryApr 27, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING ABDOMINOPERINEAL RESECTION (APR), WHEN RESECTING THE COLON, 6 HANDLES AND 6 SEPARATE RELOADS FAILED TO FIRE. THE SURGEON USED 2 BOXES OF RELOAD TO RESOLVE THE ISSUE. THE PATIENT HAD TEMPORARY DIVERTING COLOSTOMY TO ALLOW RECTAL ANASTOMOSIS TO HEAL.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14221427 ↗
• InjuryApr 13, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN SURGICAL LOW ANTERIOR RESECTION PROCEDURE, WHILE THE END OF RECTUM WAS BEING ANASTOMOSED, THE DEVICE DID NOT FIRE. FORCE WAS APPLIED ON TISSUE FOR ANASTOMOSIS, BUT PINS DID NOT COME OUT, SO TISSUE GOT SQUEEZED WITHOUT ANASTOMOSIS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE AS THE SURGEON DID THE ANASTOMOSIS BY HAND SUTURING TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 14104458 ↗
• InjuryJun 23, 2021Failure 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 COLON RESECTION, ON THE COLON, THE SURGEON USED THE OPEN STAPLER WITH THE FIRST LOADING UNIT WHICH WAS LOADED AND EVERYTHING WAS FINE. THEN THE DOCTOR WANTED TO USE NEXT ONE AND THE CIRCULATING NURSE HAD TO OPEN THE NEW LOADING UNIT AND GAVE IT TO THE STERILE TABLE. THE SCRUB NURSE NOTICED THAT IT WAS NOT GOOD BECAUSE SOME WHITE PART OF THE LOADING UNIT WAS DISENGAGED. THE OPERATOR OPENED A NEW ONE AND USED IT, BUT ONLY PART OF THE UNIT FIRED, THEN THE DOCTOR OPENED AND USED THE NEXT ONE WITH THE SAME RESULT. THE SURGEON FINISHED THE ANASTOMOSIS WITHOUT A STAPLER AND USED SUTURES INSTEAD. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12051248 ↗
• MalfunctionMay 25, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. THE SURGEON USED ANOTHER DEVICE 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 11875827 ↗
• InjuryFeb 15, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN RESECTION OF DUODENAL GASTROINTESTINAL STROMAL TUMOR, WHILE STAPLING ACROSS THE DUODENUM AT THE BASE OF THE TUMOR, THE SURGEON WAS ABLE TO COMPLETE A FULL SQUEEZE OF THE HANDLE TO CLOSE THE DEVICE AND COMPLETE THE FIRING SQUEEZE, THE TISSUE WAS CUT BUT THE STAPLES DID NOT DEPLOY. THE WOUND WAS CLOSED BY HAND SUTURES. THERE WAS UNINTENDED TISSUE LOSS AND TISSUE DAMAGE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES AND THE HOSPITAL STAY WAS ALSO EXTENDED BY A WEEK. THE PATIENT WAS READMITTED DUE TO A LEAK.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 11327614 ↗
• InjuryJan 14, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, ON AN OPEN LOBECTOMY, WHILE STAPLING THE LOBE, THE DEVICE HAD POOR STAPLE LINE FORMATION. THE SURGEON OVER-SEWED THE STAPLE LINE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11169075 ↗
• InjuryOct 28, 2020Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE TO DISSECT THE RECTUM, SOME STAPLES WERE OPEN AND NOT FORMED PROPERLY AFTER FIRING. THE SURGEON SUTURED TO CORRECT THE OPEN TISSUE. THE DOCTOR FINISHED THE SURGERY WITH A COLOSTOMY.

  Patient problems: No Code Available

  MAUDE report 10745891 ↗
• MalfunctionSep 22, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING SIGMOIDECTOMY, WHEN STAPLING THE SIGMOID, THE INSTRUMENT WAS TRIGGERED BUT NO STAPLES WERE SET. A SECOND TRY WITH A NEW LOADING UNIT WAS UNSUCCESSFUL. THE HANDLE AND RELOAD WERE SET ASIDE AND NEW HANDLE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567610 ↗
• InjurySep 8, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE PARTIALLY FIRED. IT WAS STATED THAT TWO LOADING UNITS HAD THE SAME MALFUNCTION DURING THE EVENT. OVER SEWING WAS DONE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 10500944 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ONE DAY POST-OPERATIVELY ON AN EXPLORATORY LAPAROSCOPY SURGERY, THE PATIENT HAD FISTULA. THE PATIENT WAS RE-OPERATED TO RESOLVE THE ISSUE.

  Patient problems: Fistula; No Code Available

  MAUDE report 10104340 ↗
• MalfunctionApr 2, 2020Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, WHILE TRANSECTING THE STOMACH DURING AN OPEN WHIPPLE PROCEDURE, THE STAPLER DID NOT FIRE AND WAS PRE-FIRED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9915848 ↗
• InjurySep 24, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN LOBECTOMY, TO CUT SOME PARENCHYMA, THE STAPLES DID NOT DEPLOY, THE DEVICE CUTS THE TISSUE. THEY CLOSED WITH VERY THICK TISSUE AND DID NOT SEE THE STAPLER FROM THE ANVIL SIDE SO THEY CANNOT SAY HOW THE STAPLER WAS CLOSED. THEY CLOSED THE STAPLER (HANDLE TO HANDLE) AND THEN CUT THE TISSUE WITH A KNIFE. WHEN THEY OPENED THE STAPLER THEY SAW SOME OF THE STAPLE LINE WAS CLOSED PROPERLY, HOWEVER AROUND 3 CM OF STAPLES WERE NOT CLOSED AND THEY HAD BLEEDING, WHICH HAS TO BE STOPPED WITH SUTURES AND TWO OTHER CARTRIDGES TO CLOSE THE PARENCHYMA. THE DEVICE WAS FIRED AND STAPLES WAS CLOSED PROPERLY IN DISTAL HALF 40% FROM THE PIN. THE STAPLES WERE OPEN PROXIMAL TO THE PIN. THE OPERATION WAS LONGER THAN THIRTY MINUTES. THERE WAS PATIENT INJURY.

  Patient problems: Injury; No Code Available; Tissue Damage

  MAUDE report 9107999 ↗
• MalfunctionJul 11, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS ABLE TO PERFORM FULL, COMPLETE SQUEEZE OF THE HANDLE BUT THE DEVICE DID NOT FIRE. THE SURGEON HAND SEWED THE ANASTOMOSIS TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8780247 ↗

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-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-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-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-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-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-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-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT

…and 58 more.