TA TA9048SRecalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 10884521043275), received between Jan 5, 2017 and Sep 24, 2026 — classified as 2 deaths, 51 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (72 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 186 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Entrapment of Device

  It was reported during the procedure there was issue after firing the stapler. Device got locked on tissue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876997 ↗
• MalfunctionJun 4, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A COMPREHENSIVE RESECTION OF A RIGHT RETROPERITONEAL SARCOMA WITH RIGHT NEPHRECTOMY AND RIGHT HEMICOLECTOMY, A BLUE RELOAD USED WITH A RELOADABLE STAPLER FAILED TO FULLY SEAL THE ANASTOMOSIS, RESULTING IN AN INTRAOPERATIVE ANASTOMOTIC LEAK. STAPLE FORMATION ISSUES AND STAPLE LINE BLEEDING AFTER FIRING WERE ALSO REPORTED. A NEW HANDLE AND RELOAD WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 25402628 ↗
• MalfunctionMay 7, 2026Mechanics Altered

  IT WAS REPORTED THAT AN INTESTINAL OBSTRUCTION REQUIRED MULTIPLE RESECTIONS OF THE STOMACH, SMALL INTESTINE, AND COLON, AND DURING THE STOMACH RESECTION, AN OPEN STAPLER WAS CHOSEN AS THE FIRST OPTION AND DID NOT RELEASE STAPLES. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 25116896 ↗
• MalfunctionMay 4, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN SURGEON FIRED THE STAPLER TO REMOVE THE BOWEL, THE STAPLER ONLY CUT BUT DID NOT DEPLOY THE STAPLES. ALL STAPLES WERE LEFT ON THE GUN.

  Patient problems: Tissue Breakdown

  MAUDE report 25067861 ↗
• MalfunctionMar 30, 2026Failure to Align

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY, THE JAWS BENT AND WERE UNABLE TO BE USED.

  Patient problems: Insufficient Information

  MAUDE report 24721301 ↗
• MalfunctionMar 18, 2026Expulsion

  IT WAS REPORTED THAT DURING AN OPEN PROCEDURE, FULL, COMPLETE SQUEEZES OF THE HANDLE WERE PERFORMED, AND THE HANDLE REMAINED IN THE CLOSED POSITION FOLLOWING THE SECOND COMPLETE SQUEEZE. HOWEVER, THE DEVICE DID NOT FIRE, ALL STAPLES WERE STILL IN THE RELOAD HALF DEPLOYED AND UNFORMED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY FIVE MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634291 ↗
• MalfunctionMar 18, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630739 ↗
• MalfunctionMar 13, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591579 ↗
• MalfunctionMar 3, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A GASTRIC RESECTION, THE ACCOUNT PERFORMED FULL, COMPLETE SQUEEZES OF THE HANDLE, AND TISSUE WAS CUT WITHOUT STAPLES BEING DEPLOYED. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE.

  Patient problems: Tissue Breakdown

  MAUDE report 24498946 ↗
• MalfunctionJan 13, 2026Failure to Fire

  IT WAS REPORTED THAT INTRAOPERATIVELY, A SMALL BOWEL FISTULA DUE TO AN INCISIONAL HERNIA PLAQUE VIA LAPAROTOMY. TO PERFORM THE ANASTOMOSIS, THE SURGEON FIRST CREATED A LATERAL ANASTOMOSIS OF THE SMALL BOWEL USING A GIA STAPLER, THEN A LATERAL ANASTOMOSIS USING A TA STAPLER. THE INITIAL TA STAPLER DID NOT FIRE, NO STAPLES WERE DELIVERED. A SECOND TA STAPLER WAS RETRIEVED. THIS TIME, THE STAPLER WAS CLOSED ON THE SMALL BOWEL, BUT ONLY A FEW STAPLES WERE PLACED, AND THE INCISION WAS NOT COMPLETELY CLOSED. THE ANASTOMOSIS WAS NOT PERFORMED UNDER THE MOST ASEPTIC CONDITIONS POSSIBLE. THERE WAS INJURY TO THE EDGES OF THE ANASTOMOSIS, A CUT IN THE SMALL BOWEL, AND CONSEQUENT SHORTENING OF THE ANASTOMOSIS. TWO ADDITIONAL STAPLERS FROM ANOTHER COMPANY WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: Failure to Anastomose

  MAUDE report 24058135 ↗
• MalfunctionJan 13, 2026Failure to Form Staple

  IT WAS REPORTED THAT INTRAOPERATIVELY, A SMALL BOWEL FISTULA DUE TO AN INCISIONAL HERNIA PLAQUE VIA LAPAROTOMY. TO PERFORM THE ANASTOMOSIS, THE SURGEON FIRST CREATED A LATERAL ANASTOMOSIS OF THE SMALL BOWEL USING A GIA STAPLER, THEN A LATERAL ANASTOMOSIS USING A TA STAPLER. THE INITIAL TA STAPLER DID NOT FIRE, NO STAPLES WERE DELIVERED. A SECOND TA STAPLER WAS RETRIEVED. THIS TIME, THE STAPLER WAS CLOSED ON THE SMALL BOWEL, BUT ONLY A FEW STAPLES WERE PLACED, AND THE INCISION WAS NOT COMPLETELY CLOSED. THE ANASTOMOSIS WAS NOT PERFORMED UNDER THE MOST ASEPTIC CONDITIONS POSSIBLE. THERE WAS INJURY TO THE EDGES OF THE ANASTOMOSIS, A CUT IN THE SMALL BOWEL, AND CONSEQUENT SHORTENING OF THE ANASTOMOSIS. TWO ADDITIONAL STAPLERS FROM ANOTHER COMPANY WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: Failure to Anastomose

  MAUDE report 24057791 ↗
• MalfunctionJan 6, 2026Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A RIGHT HEMICOLECTOMY, WHEN REMOVING THE BOWEL TUMOR, AFTER PLACING THE INTESTINE IN THE JAWS OF THE DEVICE AND FIRING, THE SURGEON WAITED FOR THE ALLOTTED TIME TO PASS (60 SECONDS), HOWEVER, WHEN THE DEVICE WAS OPENED, THE STAPLES WERE ONLY STICKING OUT A COUPLE OF MILLIMETER AND HAD NOT GONE THROUGH THE INTESTINE TO STAPLE TOGETHER. THE DEVICE WAS THEN CAREFULLY REMOVED AND A NEW ONE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23982637 ↗
• MalfunctionNov 18, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LEFT HEMICOLECTOMY, THE OPEN STAPLER DID NOT FIRE CORRECTLY AND PERFORMED UNFORMED STAPLES AND OPEN STAPLES AT THE LINE. AS A RESULT OF THESE ISSUES, THE DIAPHRAGM WAS OVER-SEWN, AND THORAX DRAINAGE HAD TO BE INSTALLED.

  Patient problems: Tissue Breakdown

  MAUDE report 23583874 ↗
• MalfunctionOct 15, 2025Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299535 ↗
• MalfunctionSep 11, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN ILEOCECAL RESECTION, WHEN THE SURGEON USED THE STAPLER, IT MALFUNCTIONED. THE SURGEON SQUEEZED THE HANDLE; IT CLICKED INTO PLACE, AND THE SPECIMEN WAS CUT, BUT WHEN THE STAPLER WAS BEING REMOVED, THE STAPLES WERE ONLY PARTIALLY DEPLOYED. A NEW STAPLE WAS DEPLOYED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23028188 ↗
• MalfunctionAug 22, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THE OPEN STAPLER EXPERIENCED FIRING ISSUES DURING USE. THE HANDLE REMAINED IN THE CLOSED POSITION AFTER THE SECOND COMPLETE SQUEEZE, AND SOME STAPLES WERE MISSING, AS THE REPORTED STAPLE LINE MAY NOT HAVE BEEN FIRED CORRECTLY. THE DEVICE WAS REPLACED.

  Patient problems: Tissue Breakdown

  MAUDE report 22877096 ↗
• MalfunctionAug 6, 2025Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT DURING THE ILEOCOLIC RESECTION FOR CHRONIC APPENDICITIS, THE STAPLE LINE WAS INCOMPLETE AFTER FIRING, UNCLOSED STAPLES WERE OBSERVED AT THE PIN END, AND SOME STAPLES REMAINED IN THEIR ORIGINAL U SHAPE AND WERE LOOSE ON THE SURFACE OF THE BOWEL. IT WAS ALSO REPORTED THAT TISSUE WAS CUT BEFORE CONFIRMING STAPLE DEPLOYMENT. AS A RESULT, A PROCEDURAL INTERVENTION WAS REQUIRED TO RESECT AND RE-STAPLE THE TISSUE. THE ACCOUNT CONFIRMED THAT FULL, COMPLETE SQUEEZES OF THE HANDLE WERE PERFORMED. THE STAPLER FELT AS THOUGH IT CLOSED AND FIRED AS NORMAL, BUT UPON REMOVAL, THE ISSUES WERE IDENTIFIED. THE PRODUCT WAS REPLACED.

  Patient problems: Tissue Breakdown

  MAUDE report 22731417 ↗
• MalfunctionJul 31, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER PERFORMING A FULL, COMPLETE SQUEEZE OF THE HANDLE, THE HANDLE RETURNED TO AN OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE AND THEN REMAINED IN THE CLOSED POSITION FOLLOWING THE COMPLETE SQUEEZE OF THE HANDLE, BUT THE STAPLE LINE WAS INCOMPLETE. A NEW DEVICE OF THE SAME TYPE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 22676746 ↗
• MalfunctionJun 17, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A PROCEDURE, WHEN THE SURGEON PERFORMED A FULL COMPLETE SQUEEZE OF THE HANDLE, THE STAPLER DID NOT FIRE. A NEW OPEN STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22222467 ↗
• MalfunctionMay 9, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE USER PERFORMED A FULL, COMPLETE SQUEEZE OF THE HANDLE, BUT THERE WAS AN INCOMPLETE STAPLE LINE. THESE ISSUES LED TO UNSPECIFIED EXTENDED SURGICAL TIME AS ADDITIONAL TISSUE RESECTION OF 20 CENTIMETERS AND RE-STAPLING WERE REQUIRED.

  Patient problems: Tissue Breakdown

  MAUDE report 21997902 ↗
• MalfunctionApr 25, 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 THE PROCEDURE, THE STAPLER DID DIVIDE THE BOWEL, AND ONCE STAPLER RELEASED BOWEL EDGES FALL APART WITH EVIDENCE OF FIRING OF STAPLES AS STAPLES WERE AT THE EDGE OF THE BOWEL. CONVENTIONAL SUTURING WAS PERFORMED TO RESOLVE THE ISSUE.

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

  MAUDE report 21909358 ↗
• MalfunctionApr 24, 2025Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE STAPLER PARTIALLY FIRED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

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

  MAUDE report 21902876 ↗
• MalfunctionFeb 20, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ILEOCECAL RESECTION (OPEN PROCEDURE), THE TA9048S TA 90-4.8 RELOADABLE STAPLER, THE SURGEON WAS UNABLE TO FIRE THE DEVICE. THE DEVICE WAS BEING APPLIED TO STAPLE THE SMALL BOWEL WHEN THESE ISSUES OCCURRED. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED TO PROCEED WITH THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422221 ↗
• MalfunctionFeb 11, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION (LAR), INVOLVING THE TA9048S TA 90-4.8 RELOADABLE STAPLER, THERE WERE FIRING ISSUES, AND THE STAPLES DID NOT DEPLOY. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER OPEN STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354417 ↗
• MalfunctionOct 14, 2024Failure to Fire; Physical Resistance/Sticking; Failure to Fire; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE. THE ACCOUNT WAS NOT ABLE TO PERFORM FULL, COMPLETE SQUEEZES OF THE HANDLE. THE HANDLE ALSO DID NOT RETURN TO THE OPEN POSITION FOLLOWING THE FIRST FULL SQUEEZE OF THE HANDLE.

  Patient problems: Insufficient Information

  MAUDE report 20440663 ↗

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-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-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-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-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-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-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-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-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-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT

…and 58 more.