Endo GIA 030415Recalls & reported problems

Summary

The FDA's MAUDE database contains 973 adverse event reports that list this exact device (DI 10884523002935), received between Apr 28, 2017 and Nov 3, 2025 — classified as 124 injuries, 849 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (465 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 973 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A THORACOSCOPIC LOBECTOMY, THE DEVICE WAS UNABLE TO FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE HANDLE AND RELOAD TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457878 ↗
• MalfunctionJul 16, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER DURING THE SINGLE-PORT THORACOSCOPIC RIGHT UPPER LOBECTOMY, WHEN THE RELOAD WAS USED TO SEPARATE THE RIGHT UPPER LOBE BRONCHUS, THE RELOAD COULD NOT BE CLOSED OR FIRED. THE RELOAD WAS REPLACED TO FIX THE ISSUE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517291 ↗
• MalfunctionJul 10, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL GASTRECTOMY, DURING DETACHMENT OF THE GASTRIC TISSUE, AFTER PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZED, AND THE DEVICE DID NOT FIRE. A NEW BLACK RELOAD WITH THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468299 ↗
• MalfunctionJun 7, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, THE USE OF THE MANUAL STAPLER, THE JAWS CLOSED AND COULDN'T BE OPENED, AND DID NOT FIRE. IT WAS NOTED THAT NOT INVOLVING TISSUE. THE RELOAD WAS REMOVED AND REPLACED WITH ANOTHER RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163604 ↗
• MalfunctionMay 30, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LUNG SEGMENT RESECTION, THE DEVICE FAILED TO 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 22116868 ↗
• MalfunctionApr 17, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LEFT UPPER LOBE SURGERY, WHEN DETACHING THE BRONCHUS, A CLICKING SOUND WAS HEARD WHEN USING THE STAPLER. THERE WAS NO RESPONSE WHEN SQUEEZING THE HANDLE, THE RELOAD HAD POOR STAPLE FORMATION AND THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE SURGEON COMPLETED THE SURGERY AFTER REPLACEMENT OF NEW HANDLE AND RELOAD AND RE-ANASTOMOSIS WAS DONE TO FIX THE STAPLE LINE.

  Patient problems: Tissue Breakdown

  MAUDE report 21856358 ↗
• MalfunctionJan 13, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT THORACOSCOPIC LOBECTOMY PROCEDURE, WHEN CUTTING LUNG TISSUE, THE STAPLER DID NOT FIRE. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138383 ↗
• MalfunctionNov 19, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MEDIASTINAL TUMOR RESECTION, BEFORE CUTTING THE MEDIASTINUM TISSUE, THE NURSE CONNECTED THE RELOAD AND HELD THE GRIP TIGHTLY, BUT THE JAWS DID NOT CLOSE. TO RESOLVE THE ISSUE, A NEW RELOAD AND HANDLE WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20729739 ↗
• MalfunctionSep 20, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER FIRING, IT WAS OBSERVED THAT THE STAPLE LINE WAS PROXIMALLY INCOMPLETE. THE ISSUE OCCURRED IN TWO RELOADS. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20267148 ↗
• MalfunctionSep 20, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, THE STAPLE LINE WAS INCOMPLETE ON THE PROXIMAL SIDE FOR ALL FOUR RELOADS. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20267054 ↗
• MalfunctionSep 20, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, THE STAPLE LINE WAS INCOMPLETE ON THE PROXIMAL SIDE FOR ALL FOUR RELOADS. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20266971 ↗
• MalfunctionSep 16, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON FOUR RELOADS, THE STAPLE LINE WAS PROXIMALLY INCOMPLETE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20232076 ↗
• MalfunctionSep 16, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON FOUR RELOADS, THE STAPLE LINE WAS PROXIMALLY INCOMPLETE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20232075 ↗
• MalfunctionSep 16, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON FOUR RELOADS, THE STAPLE LINE WAS PROXIMALLY INCOMPLETE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20229492 ↗
• MalfunctionAug 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VATS (VIDEO ASSISTED THORACOSCOPIC SURGERY) LUNG WEDGE RESECTION PROCEDURE, THE STAPLER WAS NOT ABLE TO FIRE, THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026426 ↗
• MalfunctionAug 5, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY, AFTER THE SURGEON PRESSED THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZED, AND THE DEVICE DID NOT FIRE. THE SAME ISSUE OCCURRED ON THE SECOND RELOAD WITH THE SECOND HANDLE. A THIRD HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19913327 ↗
• MalfunctionAug 5, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY, AFTER THE SURGEON PRESSED THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZED, AND THE DEVICE DID NOT FIRE. THE SAME ISSUE OCCURRED ON THE SECOND RELOAD WITH THE SECOND HANDLE. A THIRD HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912915 ↗
• MalfunctionJul 25, 2024Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE USING THE FIRST RELOAD, THE STAPLE LINE WAS COMPLETE, BUT THE TISSUE WAS PARTIALLY CUT. WHILE ON THE SECOND RELOAD, IT WAS DIFFICULT TO FIRE. THE TISSUE WAS RESECTED AND RE-STAPLED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19829630 ↗
• MalfunctionApr 25, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A GENERAL LAPAROSCOPIC PROCEDURE, IN GASTROINTESTINAL TISSUE ANASTOMOSIS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT COULD NOT SQUEEZE THE HANDLE. THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW RELOAD OF THE SAME TYPE WAS USED WITH THE SAME HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183633 ↗
• MalfunctionApr 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VATS (VIDEO-ASSISTED THORACOSCOPIC SURGERY) LOBECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THE ISSUE OCCURRED IN TWO RELOADS. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19156105 ↗
• MalfunctionApr 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VATS (VIDEO-ASSISTED THORACOSCOPIC SURGERY) LOBECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THE ISSUE OCCURRED IN TWO RELOADS. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154178 ↗
• MalfunctionApr 19, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE PROCEDURE, AT THE TIME OF STAPLING, THE TWO RELOADS DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19147932 ↗
• MalfunctionApr 5, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE PROCEDURE, WHEN STAPLING, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT THE STAPLER WAS UNABLE TO FIRE. THE ISSUE OCCURRED ON ANOTHER RELOAD AS WELL. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055101 ↗
• MalfunctionApr 5, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE PROCEDURE, WHEN STAPLING, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT THE STAPLER WAS UNABLE TO FIRE. THE ISSUE OCCURRED ON ANOTHER RELOAD AS WELL. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054928 ↗
• MalfunctionApr 5, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VATS (VIDEO ASSISTED THORACOSCOPIC SURGERY) LUNG WEDGE SURGERY, THE STAPLER WAS UNABLE TO FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. A NEW RELOAD AND HANDLE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051787 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825. 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 tra
• 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-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-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-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-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-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-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-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-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-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

…and 58 more.