Endo GIA 030449Recalls & reported problems

Summary

The FDA's MAUDE database contains 716 adverse event reports that list this exact device (DI 10884523003505), received between May 2, 2017 and Feb 19, 2026 — classified as 2 deaths, 118 injuries, 596 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (384 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 716 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A ROBOTIC THORACOSCOPIC PROCEDURE WITH BEDSIDE APPLICATION, A HANDLE AND RELOAD WERE CONNECTED AND INSERTED INTO THE PATIENT, AND AFTER THE TARGET TISSUE WAS POSITIONED BETWEEN THE JAWS AND THE MAGAZINE WAS CLOSED, THE MAGAZINE COULD NO LONGER BE REOPENED. DUE TO THE INABILITY TO DISENGAGE THE INSTRUMENT, THE PROCEDURE WAS INTERRUPTED AND CONVERTED FROM ROBOTIC THORACOSCOPIC TO OPEN SURGERY IN ORDER TO MANUALLY RETRIEVE THE INSTRUMENT USING OTHER SURGICAL INSTRUMENTS. THE HANDLE WAS REPLACED AND ANOTHER RELOAD WAS USED TO CONTINUE THE CASE.

  Patient problems: Laceration(s)

  MAUDE report 24397696 ↗
• MalfunctionNov 6, 2025Misfire; Difficult to Open or Close; Misfire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLE CARTRIDGE DID NOT CLOSE TIGHTLY, AND AFTER FIRING OUT, THE CUTTING STAPLER MALFUNCTIONED AND COULD NOT BE USED.

  Patient problems: Insufficient Information

  MAUDE report 23489818 ↗
• MalfunctionSep 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SUBTOTAL GASTRECTOMY, WHEN THE GASTRIC BODY WAS DETACHED, THE DEVICE FAILED TO FIRE AFTER THE STAPLE WAS PROPERLY LOADED AND THE HANDLE WAS GRIPPED TIGHTLY, DESPITE PRESSING THE GREEN BUTTON. THE DEVICE HANDLE WAS REPLACED WITH A NEW ONE, WHICH FUNCTIONED NORMALLY AND ALLOWED THE SURGERY TO BE COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991827 ↗
• MalfunctionJul 17, 2025Entrapment of Device; Misfire; Failure to Cut; Failure to Fire; Entrapment of Device; Misfire; Failure to Cut; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, THE DEVICE GOT STUCK AND COULD NOT BE REMOVED. IT COULD NOT CUT OR STOP THE BLEEDING. A NEW HANDLE WAS USED TO PERFORM THE CUTTING AND STAPLING OF THE WOUND.

  Patient problems: Insufficient Information

  MAUDE report 22530648 ↗
• MalfunctionJun 2, 2025Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, AN ULTRASONIC SCALPEL WAS USED TO CUT OPEN THE ANTERIOR WALL OF THE STOMACH TO EXPOSE THE TUMOR. THE DOCTOR USED THE CUTTING STAPLER AND DISPOSABLE RELOAD FOR ENDOSCOPY IN A STANDARDIZED MANNER. THE RELOAD CLAMP WAS NOT CLOSED TIGHTLY, THE TISSUE SLID FORWARD WHEN FIRED, AND THE STAPLES WERE DEFORMED, RESULTING IN ANASTOMOSIS FAILURE AND TISSUE BLEEDING. LOCAL HEMOSTASIS WAS PERFORMED IMMEDIATELY, THE PATIENT'S VITAL SIGNS WERE MONITORED MORE CLOSELY DURING THE OPERATION, AND ANOTHER STAPLER WAS REPLACED TO CONTINUE THE OPERATION.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22128748 ↗
• MalfunctionMar 27, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A ATYPICAL LAPAROSCOPIC PULMONARY RESECTION, THE SURGEON INITIALLY USED THE MANUAL SHORT HANDLE, WHICH WORKED FOR THE FIRST RELOAD BUT DID NOT FIRE WITH THE SECOND RELOAD. SECOND MANUAL SHORT HANDLE WAS USED BUT DID NOT FIRE WITH THE SECOND RELOAD. ATTEMPTS TO USE ANOTHER MANUAL HANDLE WITH THE SECOND RELOAD BUT ALSO FAILED TO FIRE. ULTIMATELY, A PURPLE RELOAD WAS USED SUCCESSFULLY. AFTER THE PROCEDURE, A NURSE TESTED THE DEVICES, CONFIRMING THAT THE SECOND MANUAL SHORT HANDLE AND THE MANUAL HANDLE WORKED PROPERLY WITH THE PURPLE RELOADS. BOTH HANDLES AND RELOAD WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS EXTENDED SURGICAL TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21714136 ↗
• MalfunctionFeb 26, 2025Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LEFT COLECTOMY, THE DEVICE LOCKED ON TISSUE. THE STAPLER WAS MANUALLY REMOVED WHEN PIECES OF THE COLON WAS OUT OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21471398 ↗
• MalfunctionFeb 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE STAPLER, THE SURGEON WAS UNABLE TO SQUEEZE THE MANUAL HANDLE AND THE STAPLER DID NOT FIRE THE RELOAD. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED, AND A NEW HANDLE WAS USED TO FIRE THE SAME RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405150 ↗
• 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 21138371 ↗
• MalfunctionJan 9, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE HANDLE, THE HANDLE SEIZING AFTER FOUR ATTEMPTS TO RELOAD IT. THIS ISSUE WAS IDENTIFIED AS A FIRING PROBLEM WITH THE MANUAL HANDLE. THE HANDLE WAS SUBSEQUENTLY REPLACED WITH ANOTHER OF THE SAME REFERENCE AND LOT NUMBER RESULTED IN LOSS OF TIME. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114721 ↗
• MalfunctionJan 8, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATICODUODENECTOMY, WHILE ON CLOSURE AND DETACHMENT OF DUODENUM, THE DEVICE DID NOT FIRE. A NEW HANDLE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105946 ↗
• MalfunctionJan 8, 2025Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION OF RECTAL CANCER, DURING CLOSURE AND DIVISION OF THE RECTUM, THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON AND THE HANDLE COULD NOT BE SQUEEZED. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THEISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103054 ↗
• MalfunctionJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL RECTAL SURGERY , DURING THE CLOSURE AND DETACHMENT OF THE RECTUM, THE STAPLER WAS UNABLE TO FIRE, AND THE SURGEON COULD NOT SQUEEZE THE HANDLE. THE DEVICE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102573 ↗
• MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING APPENDECTOMY, INVOLVING THE MANUAL HANDLE AND RELOAD. AFTER FIRING, THE SURGEON IDENTIFIED SMALL COMPONENTS IN THE SITUS, WHICH WERE SUSPECTED TO HAVE ORIGINATED FROM EITHER THE HANDLE OR THE LOADING UNIT. ALL COMPONENTS WERE REMOVED FROM THE SITUS AND SUBSEQUENTLY DISCARDED. THERE WERE NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096353 ↗
• MalfunctionJan 2, 2025Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PANCREATICODUODENECTOMY, THE RELOAD WAS UNABLE TO FIRE WHILE BEING APPLIED TO THE GASTRODUODENAL ARTERY. THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THE ISSUE WAS RESOLVED BY REPLACING THE STAPLER WITH A NEW DEVICE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21053808 ↗
• MalfunctionDec 19, 2024Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL SURGERY OF RECTAL CANCER, THE DEVICE DID NOT FIRE. ANOTHER RELOAD AND HANDLE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20974682 ↗
• MalfunctionDec 9, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PNEUMATIC MEDIASTINOSCOPIC ESOPHAGECTOMY FOR ESOPHAGEAL CANCER, THE STAPLER DEVICE, IDENTIFIED THAT THE RELOAD, WAS NOT ABLE TO FIRE DURING THE CLOSURE AND DETACHMENT OF THE ESOPHAGUS. THE ISSUE WAS RESOLVED BY REPLACING THE MALFUNCTIONING DEVICE (HANDLE AND RELOAD) WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878546 ↗
• MalfunctionNov 19, 2024Break; Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SEGMENTECTOMY PROCEDURE, WHEN THE PACKAGE WAS OPENED, A FOREIGN OBJECT WAS FOUND IN THE BOX. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE RETURNED PRODUCT FOUND THAT A PIECE OF SHEARED RACK TEETH WAS TAPPED TO THE INSTRUMENT SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725484 ↗
• MalfunctionOct 3, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT UPPER LOBE WEDGE RESECTION, ON THE RIGHT UPPER LOBE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE, 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 20360399 ↗
• MalfunctionAug 27, 2024Failure to Fire; Noise, Audible; Failure to Fire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RADICAL SURGERY OF LUNG CANCER, WHILE CUTTING AND ANASTOMOSIS, THERE WAS A JAM AND A CLICKING SOUND WAS HEARD WHEN PRESSING THE HANDLE, WHICH AFFECTED THE NORMAL USE OF THE RELOAD. THE HANDLE WAS REPLACED. HOWEVER, THE SAME PROBLEM STILL OCCURRED. TO RESOLVE THE ISSUE, IT WAS SUTURED MANUALLY.

  Patient problems: Insufficient Information

  MAUDE report 20075634 ↗
• MalfunctionAug 26, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY, WHEN PERFORMING A VASCULAR DISSECTION, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE, THE DEVICE WAS NOT ABLE FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20069751 ↗
• MalfunctionAug 23, 2024Failure to Fire; Noise, Audible; Failure to Fire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RADICAL SURGERY OF LUNG CANCER, WHILE CUTTING AND ANASTOMOSIS, THERE WAS A JAM AND A CLICKING SOUND WAS HEARD WHEN PRESSING THE HANDLE, WHICH AFFECTED THE NORMAL USE OF THE RELOAD. THE HANDLE WAS REPLACED. HOWEVER, THE SAME PROBLEM STILL OCCURRED. TO RESOLVE THE ISSUE, IT WAS SUTURED MANUALLY.

  Patient problems: Insufficient Information

  MAUDE report 20057955 ↗
• MalfunctionAug 13, 2024Break; Component or Accessory Incompatibility; Break; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PULMONARY LOBECTOMY, ON ASSEMBLY, THE PART WHERE THE HANDLE BARREL AND THE RELOAD WERE CONNECTED WAS FOUND TO BE DAMAGED AND COULD NOT BE INSTALLED AND USED NORMALLY. THE USER REPLACED WITH A NEW HANDLE AND RELOAD FROM THE COMPANY TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973865 ↗
• MalfunctionAug 6, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LEFT UPPER LUNG RESECTION PROCEDURE, WHILE DETACHING THE LUNG PARENCHYMA, THE STAPLER DID NOT FIRE. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919784 ↗
• MalfunctionJul 10, 2024Break; Device Slipped; Difficult to Open or Close; Break; Device Slipped; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC SEGMENTECTOMY, AFTER ASSEMBLING THE THIRD RELOAD, IT FELT DULL WHEN P ULLING THE HANDLE. THERE WAS AN OBVIOUS STUCK WHEN CLOSING THE JAWS. IT WAS NOTED THAT THE FIRST TWO RELOAD FIRED NORMALLY. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT A VISUAL INSPECTION OF INTERNAL COMPONENTS REVEALED SHEARED TEETH ON THE FIRING RACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711809 ↗

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-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-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-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-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-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-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

…and 58 more.