Endo GIA EGIAUNIVXLRecalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10884523003512), received between Apr 21, 2017 and Oct 21, 2024 — classified as 10 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (57 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 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE ARTICULATING LEVER BROKE. THE ISSUE OCCURRED WITH A SECOND HANDLE. ANOTHER HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20498942 ↗
• MalfunctionOct 21, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE ARTICULATING LEVER BROKE. THE ISSUE OCCURRED WITH A SECOND HANDLE. ANOTHER HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496633 ↗
• MalfunctionOct 26, 2023Break; Failure to Fire; Break; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC, THE DEVICE FIRED FOUR RELOADS, BUT ON THE FIFTH RELOAD, THE CARTRIDGE STRUCK AND BROKEN. WHILE RELOADING THE CARTRIDGE, THE ROTATING KNOB OF THE HANDLE WAS BROKEN. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017352 ↗
• MalfunctionJul 10, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO FIRE THE DEVICE AFTER PRESSING THE GREEN BUTTON; THE HANDLE WAS LOCKED. 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 17293988 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO DAYS POST-OPERATIVE OF A SLEEVE PROCEDURE, THE PATIENT¿S HOSPITAL DISCHARGE WAS CANCELLED DUE TO INFLAMMATORY SYNDROME. THE PATIENT HAD PERSISTENT INFECTIOUS SYNDROME. EXPLORATORY LAPAROSCOPY AND WASHING AND DRAINAGE OF THE PERITONEAL CAVITY FOR HEMATOMA ON THE GASTRECTOMY STAPLE LINE WERE PERFORMED THE NEXT DAY. BLUE TEST INDICATED THAT THERE WAS NO FISTULA. THE PATIENT WAS DISCHARGED AFTER FOUR DAYS.

  Patient problems: Inflammation; Post Operative Wound Infection

  MAUDE report 17248300 ↗
• MalfunctionMay 24, 2023Misfire; Noise, Audible; Misfire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VATS (VIDEO-ASSISTED THORACIC SURGERY) RESECTION OF LUNG TISSUE, THE FIRST HANDLE AND FIRST RELOAD COULD NOT BE FIRED AND A LOUD CRACK SOUND WAS HEARD. A SECOND HANDLE AND SECOND RELOAD WERE THEN USED; AND WHILE RESECTIONING THE LUNG PARENCHYM, A LOUD CRACK SOUND WAS HEARD FROM THE SECOND HANDLE. AFTERWARDS IT COULD NOT BE FIRED; IT PARTIALLY FIRED. ANOTHER HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16997990 ↗
• MalfunctionMay 15, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC PROCEDURE, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW HANDLE OF THE SAME TYPE WAS USED WITH THE SAME RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931187 ↗
• MalfunctionMar 10, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, WHILE AT THE RECTUM, THE SURGEON PRESSED THE GREEN BUTTON AND SQUEEZED THE HANDLE; HOWEVER, THE DEVICE DID NOT FIRE. THERE WAS A SEROSA TISSUE DAMAGED SINCE THE SURGEON HAD TO REMOVE MORE RECTUM TISSUE FOR EXTRA MOBILIZATION TO FIRE AGAIN LOWER THAN THE FIRST ATTEMPT. THESE HAPPENED WITH THE FIRST HANDLE AND THREE RELOADS. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16525188 ↗
• MalfunctionJan 23, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, THE FIRST TWO RELOADS WAS USED NORMALLY. WITH THE THIRD BACK RELOAD, THE DEVICE FIRED ON FIRST ACTIVATION BUT THE HANDLE COULD NOT BE SQUEEZED ON THE SECOND ACTIVATION. THE USER WAS ABLE TO OPEN THE CLAMP AND WAS REPLACED WITH A NEW EXTRA LONG HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229863 ↗
• MalfunctionOct 6, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE, THE SURGEON WAS NOT ABLE TO CLOSE THE JAW, HENCE STAPLER DID NOT FIRE. A NEW HANDLE AND RELOAD WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15556145 ↗
• MalfunctionJul 12, 2022Break; Break

  ACCORDING TO THE REPORTER DURING THE LAPAROSCOPIC LOW ANTERIOR RESECTION, WHILE STAPLING, THE STAPLER BROKE DURING ARTICULATION. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14992922 ↗
• MalfunctionMar 31, 2022Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOW ANTERIOR RESECTION, WHEN RESECTING RECTAL STUMP, THE DEVICE WAS UNABLE TO FIRE. THE RELOAD WAS ALSO UNABLE TO UNLOAD. 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 13967301 ↗
• MalfunctionSep 2, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING THE FIRING AT THE GREATER CURVATURE, THE HANDLE DID NOT FIRE FOUR RELOADS. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413507 ↗
• MalfunctionMay 10, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICES DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797097 ↗
• MalfunctionMar 18, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY, UPON COLON RESECTION, THERE WAS PROBLEM UNLOADING THE DEVICE AND SHAFT OF THE HANDLE BROKE OFF. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516760 ↗
• MalfunctionMar 10, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY, THE SURGEON ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE AND THE DEVICE DID NOT FIRE. THE SURGEON THEN 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 11453992 ↗
• MalfunctionFeb 17, 2021Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. IT WAS ALSO REPORTED THAT THE SHAFT OF THE HANDLE BROKE OFF. ANOTHER LOADING UNIT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337494 ↗
• MalfunctionNov 6, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC STOMACH RESECTION, DURING STAPLING, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10801790 ↗
• MalfunctionSep 17, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS NOT ABLE TO PRESS THE GREEN BUTTON, COULD NOT SQUEEZE THE HANDLE AND THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10548833 ↗
• MalfunctionSep 3, 2020Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC BARIATRIC PROCEDURE, WHILE DEVICE WAS CLOSED ON THE TISSUE FOR FIRING, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT AFTER THE HANDLE WAS SQUEEZED, THE JAWS OF THE DEVICE OPENED AND THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. ANOTHER HANDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10489002 ↗
• MalfunctionJul 1, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE STAPLER MISFIRED.

  Patient problems: No Information

  MAUDE report 10218801 ↗
• MalfunctionJun 15, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE STAPLING THE STOMACH DURING THE SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE DID NOT FIRE EVEN THOUGH ITS HANDLE CAN BE SQUEEZED AND ITS GREEN BUTTON WAS PRESSED. A NEW STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10153499 ↗
• MalfunctionMay 27, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE FIRST BLACK RELOAD WAS NOT ABLE TO CLOSE PROPERLY AND WAS UNABLE TO FIRE. WHEN USED WITH THE TWO GREEN LEGACY RELOADS, THE DEVICE WAS ALSO NOT ABLE TO FIRE. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10091647 ↗
• MalfunctionApr 8, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING BYPASS-GASTRECTOMY, THE DEVICE WAS NOT ABLE TO FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9936567 ↗
• MalfunctionApr 8, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING BYPASS-GASTRECTOMY, THE DEVICE WAS NOT ABLE TO FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9936545 ↗

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-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-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-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-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-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-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-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-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT

…and 58 more.