Endo GIA 030452Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884523002836), received between Aug 31, 2017 and Sep 9, 2025 — classified as 5 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (12 reports).

1 FDA recall record name this device's identifier.

72 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.

Recalls naming this device

1. Apr 26, 2018Class IITerminated

   Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

   Z-1816-2018 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A RESECTION OF THE ZENKER DIVERTICULUM, A PARTIAL FIRE WAS OBSERVED IN WHICH THE RELOAD WAS FIRED TO 60%, AND THE REMAINDER WAS NOT FIRED AND DID NOT CUT. THE RELOAD WAS REPLACED WITH A SECOND ONE, WHICH EXHIBITED THE SAME ISSUES. THE THIRD AND FOURTH RELOADS FUNCTIONED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001301 ↗
• MalfunctionSep 9, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A RESECTION OF THE ZENKER DIVERTICULUM, A PARTIAL FIRE WAS OBSERVED IN WHICH THE RELOAD WAS FIRED TO 60%, AND THE REMAINDER WAS NOT FIRED AND DID NOT CUT. THE RELOAD WAS REPLACED WITH A SECOND ONE, WHICH EXHIBITED THE SAME ISSUES. THE THIRD AND FOURTH RELOADS FUNCTIONED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999928 ↗
• MalfunctionMay 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN APPENDECTOMY PROCEDURE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE HOWEVER THE DEVICE DID NOT FIRE. ANOTHER HANDLE AND RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19394398 ↗
• MalfunctionApr 5, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MUKO MYOTOMY AT ZENKER¿S DIVERTICULUM, AFTER THE GREEN FIRING BUTTON WAS PUSHED, THE LOOP HANDLE RETURNED INTO THE FIRING POSITION. THE SURGEON SQUEEZED THE LOOP HANDLE ALL THE WAY BACK. THE CLAMP COVER MOVED FORWARDS AND THE PROXIMAL STAPLES WERE FIRED. THE STAPLE LINE WAS INCOMPLETE DISTALLY. IN ORDER TO SQUEEZE THE LOOP HANDLE THE SECOND TIME, THE SURGEON RELEASED THE LOOP HANDLE ,AND IT RETURNED BACK INTO THE FIRING POSITION. THE LOOP HANDLE DID NOT LOCK, IT WAS POSSIBLE TO SQUEEZE IT BUT THERE WAS NO DRAG, AND THE CLAMP COVER DID NOT MOVE. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055835 ↗
• MalfunctionMar 9, 2023Component or Accessory Incompatibility; Detachment of Device or Device Component; Component or Accessory Incompatibility; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHILE SETTING UP THE DEVICE PRIOR TO USING ON THE PATIENT, THE RELOAD COULD NOT BE FULLY PLACED INTO THE SHAFT OF THE HANDLE. WHEN THE USER TRIED AGAIN WITH MORE FORCE, SOME TINY PLASTIC PARTS IN THE CONNECTING AREA OF THE LOADING UNIT BROKE OFF. 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 16513443 ↗
• InjuryMar 10, 2022Entrapment of Device; Misfire; Mechanics Altered; Entrapment of Device; Misfire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE FIRING, THE DEVICE GOT STUCK AND THE STAPLES DID NOT DEPLOY. THE DEVICE WAS ALMOST IMPOSSIBLE TO REMOVE FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 13720342 ↗
• MalfunctionFeb 23, 2022Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE JAWS OF THE DEVICE LOCKED ON TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 13587849 ↗
• MalfunctionFeb 22, 2021Break; Entrapment of Device; Break; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC LOBECTOMY, AT THE TIME OF BRONCHIAL RESECTION, THE PART OF THE RELOAD THAT CONNECTS TO THE HANDLE BROKE. THE JAWS WERE LOCKED ON THE TISSUE. THE USER PULLED THE BLACK RETURN KNOB, OPENED THE JAWS, AND REMOVED THE JAWS NORMALLY. ANOTHER HANDLE AND RELOAD WERE USED 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 11361200 ↗
• MalfunctionJan 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC WEDGE SEGMENTAL RESECTION PROCEDURE, THE DEVICE FIRED, HOWEVER THERE WAS "BLUE AND Y ELLOW FRAGMENTS" BREAK OFF FROM THE RELOAD. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154776 ↗
• MalfunctionDec 5, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE DEVICE MISFIRED, SEAL NOT ACHIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10952936 ↗
• MalfunctionJul 16, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS ABOUT TO BE USED FOR GASTRO JEJUNOSTOMY ON A GASTRIC BYPASS, THE NURSES RINSE THE LOAD UNIT IN WATER BEFORE USE. A YELLOW PLASTIC PARTICLE WAS DISCOVERED IN THE WATER. THEY CONTINUED USING THE RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286333 ↗
• MalfunctionJul 16, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WHEN USING THE LOADING UNIT FOR THE GASTRO JEJUNOSTOMY, A YELLOW PLASTIC PARTICLE WAS FOUND IN THE RINSE WATER FROM THE YELLOW TRANSPORT LOCK. THE LOADING UNIT WAS THEN USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10282204 ↗
• MalfunctionJul 8, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY PROCEDURE, AFTER THE DEVICE WAS ASSEMBLED, THE SURGEON PRESS THE GREEN BUTTON TO ENTER THE FIRING MODE, AND UPON FIRING THE DEVICE COULD NOT BE FIRED. THE SURGEON THEN USED ANOTHER DEVICE RELOAD 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 10246351 ↗
• MalfunctionJun 1, 2020Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, ON LAPAROSCOPIC APPENDECTOMY, DURING THE FIRST FIRING, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. IT WAS NOTED THAT PRE-FIRING OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10105831 ↗
• MalfunctionApr 1, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC LOBECTOMY, ON LUNG RESECTION, THE STAPLER WAS ABLE TO FIRE. THE STAPLE LINE WAS INCOMPLETE PROXIMALLY ON THE TWO RELOADS. THEY USED ANOTHER RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9909584 ↗
• InjuryMar 17, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC LOWER ANTERIOR RESECTION, WHILE THE INTESTINE WAS BEING CUT, THE STAPLE LINE WAS INCOMPLETE. THERE WERE ALSO POOR STAPLE FORMATIONS. ANOTHER DEVICE WAS USED FOR REANASTOMOSIS TO COMPLETE THE CASE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9843141 ↗
• MalfunctionJan 7, 2020Failure to Fire; Human-Device Interface Problem; Positioning Problem; Failure to Fire; Human-Device Interface Problem; Positioning Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ESOPHAGUS SURGERY, THE TWO HANDLES' HEAD OF THE INSTRUMENT SHAFT BROKE OFF. WITH THE FIRST RELOAD, THE LOADING UNIT CONNECTOR AND SHAFT BROKE OFF. IT WAS NOT EASY TO APPROACH WHEN THE DOCTOR WAS TRYING TO CUT THE ESOPHAGUS TISSUE. THE NEXT THREE RELOADS WERE ALSO NOT EASY TO APPROACH WHEN DOCTOR WAS TRYING TO CUT THE ESOPHAGUS TISSUE. IT WAS ALSO MENTIONED THAT THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON NOR SQUEEZE THE HANDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9561857 ↗
• MalfunctionDec 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LUNG LOBECTOMY, WHEN THE SURGEON USED THE STAPLE RELOAD TO CUT THE TISSUE, A YELLOW SCRAP WAS FOUND THAT FELL INTO THE PATIENT¿S CAVITY. THE SURGEON GRASPED THE SCRAP TO RESOLVE THE ISSUE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9399345 ↗
• MalfunctionOct 11, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, ON AN OPEN TOTAL MESORECTAL EXCISION (TME), WHEN STAPLING THE RECTUM USING THE SECOND RELOAD, THE RELOAD STOPPED STAPLING HALFWAY AND WOULD NOT FIRE FORWARD. A THIRD RELOAD WAS USED, HOWEVER, IT ALSO STOPPED HALFWAY. A FOURTH RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182247 ↗
• MalfunctionSep 25, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, WHILE ON APPENDIX, THE TWO RELOADS WAS NOT ABLE TO CLOSE. CLIPS WERE USED INSTEAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9120672 ↗
• MalfunctionAug 29, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON THE FIRST FIRING DURING A LAPAROSCOPIC APPENDECTOMY, THE FIRING DID NOT ADVANCE AND FAILED. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946510 ↗
• InjuryJul 17, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION PROCEDURE, THERE WAS A STAPLE LINE INCOMPLETE IN THE DISTAL AREA AND IT WAS ALSO REPORTED THAT THERE WAS A POOR STAPLE FORMATION WHEN THE SURGEON CUT THE RECTUM AND THE STAPLE RELOAD WAS BROKEN. ANOTHER DEVICE WAS USED TO CUT THE RECTUM AGAIN AND TO COMPLETE THE PROCEDURE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8798762 ↗
• MalfunctionJul 2, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, ON LAPAROSCOPIC SIGMOID RESECTION, AFTER CONNECTING THE RELOAD TO THE HANDLE, THE JAWS OF THE RELOAD COULD NOT BE OPENED. THE RELOAD WAS NOT ABLE TO CONTACT THE TISSUE. THE SURGEON TOOK THE DEVICE OUTSIDE OF THE CAVITY TO TRY TO OPEN HOWEVER THE JAWS WOULD STILL NOT OPEN. ANOTHER HANDLE AND RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8756264 ↗
• InjuryJun 14, 2019Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A REVISION OF BARIATRIC SURGERY FROM SLEEVE GASTRECTOMY TO ROUX-EN-Y GASTRIC BYPASS PROCEDURE, TOTAL OF 5 CARTRIDGES WERE FIRED TO DIVIDE THE STOMACH AND GASTRO-JEJUNAL (G-J) ANASTOMOSES. THE PROCEDURE AND EVERYTHING WENT WELL AND THERE WAS NO UNUSUAL EVENT WITH INSTRUMENT OR WHILE STAPLING. HOWEVER, AT THE END OF THE PROCEDURE WHEN DOCTOR PERFORMED A METHYLENE BLUE TEST, THE STAPLE LINE AT G-J ANASTOMOSES LEAKED AND METHYLENE BLUE CAME OUT FROM STAPLE LINE. THE DOCTOR OVER SEWED THE STAPLE LINE WHICH LEAKED.

  Patient problems: No Code Available

  MAUDE report 8701207 ↗
• MalfunctionApr 3, 2019Misfire; Detachment of Device or Device Component; Misfire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON RESECTION, THE STAPLER WAS ABLE TO FIRE BUT THERE WAS AN INCOMPLETE STAPLE LINE DISTALLY. IT WAS ALSO STATED THAT THE TIP OF THE CARTRIDGE WAS BENT AND THE STAPLERS FELL INTO THE PATIENT¿S CAVITY AND WERE ALSO REMOVED. THEY REPLACED THE DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8480784 ↗

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-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-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-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-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-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-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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

…and 57 more.