Endo GIA 030450Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884523002812), received between Oct 31, 2017 and Jun 2, 2020 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (6 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-1814-2018 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2020Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING FIRST FIRING OF A THORACO/LOBECTOMY PROCEDURE, WHEN THE DEVICE WAS CONNECTED TO A POWER HANDLE AND MADE AN ATTEMPT TO FIRE THE DEVICE, THE FIRING FAILED (THE FIRING COULD NOT ADVANCE). THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10109014 ↗
• MalfunctionApr 24, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOBECTOMY PROCEDURE, WHILE FIRING, THE STAPLES WERE FOUND TO HAVE FALLEN OFF FROM THE STAPLE POCKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9997452 ↗
• MalfunctionApr 8, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON THE FIRST SEALING DURING A LOBECTOMY PROCEDURE, THE SETTING WAS PERFORMED WITHOUT A PROBLEM BUT WHEN THE DOCTOR ATTEMPTED TO FIRE INSIDE THE THORACIC CAVITY, THE STAPLER COULD NOT FIRE PROPERLY. THE RELOAD WAS REPLACED AND WAS ABLE TO FIRE WITHOUT PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9937083 ↗
• MalfunctionFeb 13, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY LAPAROSCOPIC PROCEDURE, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO 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 9707062 ↗
• MalfunctionFeb 4, 2020Break; Component or Accessory Incompatibility; Break; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, WHEN AN ATTEMPT WAS MADE TO ATTACH THE CARTRIDGE TO THE HANDLE, THE PLASTIC FOR FIXING ON THE CONNECTION PART BROKE, SO THE CARTRIDGE SEEMED UNABLE TO BE CONNECTED PROPERLY. WHEN A NEW CARTRIDGE WAS CONNECTED, NO ISSUE OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9663801 ↗
• MalfunctionJan 14, 2020Component or Accessory Incompatibility; Difficult to Open or Close; Component or Accessory Incompatibility; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE RELOAD WAS INSTALLED, THE JAW COULD NOT CLOSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9586102 ↗
• InjuryJun 21, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING KIDNEY/ADRENAL GLAND SURGERY, AT THE FIRST FIRING, THE PRODUCTS WERE USED IN BLOOD VESSEL TREATMENT, BUT THE HANDLE BECAME UNABLE TO BE SQUEEZED IN THE MIDDLE. THE PROBLEM WAS SOLVED WITH CLIP(S).

  Patient problems: No Code Available

  MAUDE report 8723595 ↗
• MalfunctionMay 20, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A RADICAL NEPHRECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WERE UNABLE TO SQUEEZE THE HANDLE, THE DEVICE WAS NOT ABLE TO BE FIRED DURING VESSEL LIGATION. ANOTHER BRAND WAS USED TO COMPLETE THE CASE. THERE IS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8625499 ↗
• InjuryFeb 7, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY SURGERY, WHILE ON THE INFERIOR PULMONARY VEIN, THREE LOADING UNITS BROKE OFF. THE OPERATION TECHNIQUE WAS CHANGED AND CONVERTED TO OPEN PROCEDURE THAT THE OPERATING TIME WAS DELAYED FOR 30 MINUTES OR MORE. EXTENDED INCISION WAS ALSO REPORTED AND ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 8315577 ↗
• MalfunctionDec 28, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEPATECTOMY PROCEDURE, WHEN USING ON A BLOOD VESSEL, THE FIRST FIRING STOPPED MIDWAY. THEY REPLACED THE RELOAD AND CONTINUED USING THE HANDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8203333 ↗
• InjurySep 26, 2018Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY PROCEDURE, THE KNIFE MOVED FORWARD BUT THE STAPLES COULD NOT BE FIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: Hemostasis

  MAUDE report 7912404 ↗
• MalfunctionSep 5, 2018Failure to Fire; Device Contamination with Chemical or Other Material; Failure to Fire; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, THE STAPLER CANNOT PRESS THE GREEN BUTTON AND CANNOT SQUEEZE THE HANDLE. THE DEVICE DID NOT FIRE. A BLACK FOREIGN OBJECT IN THE STAPLE BOX WAS ALSO NOTED. REPLACED BY A NEW DEVICE TO COMPLETE THE CASE. NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7846698 ↗
• MalfunctionAug 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RENAL TRANSPLANT, AT DONOR'S SIDE, A STAPLER WAS USED FOR THE RESECTION OF RENAL ARTERY AND RENAL VEIN. OOZING WAS NOTED AFTER THE FIRINGS. THE SURGEON STOPPED THE OOZING AND COMPLETED THE CASE WITH ELECTROSURGICAL KNIFE BUT AMOUNT OF OOZING WAS MORE THAN USUAL.

  Patient problems: No Code Available

  MAUDE report 7768523 ↗
• MalfunctionAug 9, 2018Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RENAL TRANSPLANT, AT DONOR'S SIDE, A STAPLER WAS USED FOR THE RESECTION OF RENAL ARTERY AND RENAL VEIN. OOZING WAS NOTED AFTER THE FIRINGS. THE SURGEON STOPPED THE OOZING AND COMPLETED THE CASE WITH ELECTROSURGICAL KNIFE BUT AMOUNT OF OOZING WAS MORE THAN USUAL.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 7767465 ↗
• MalfunctionMay 18, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STAPLER WAS UNABLE TO FIRE. THEY NOTED THAT THEY WERE ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7525937 ↗
• MalfunctionMar 2, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER: THE ANVIL CANNOT BE OPENED WHEN RELOADING THE HANDLE. THE PROBLEM WAS NOTICED WHEN TESTING PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY. THE CURRENT CONDITION OF THE PATIENT IS STABLE. NO MEDICAL INTERVENTION WAS REQUIRED AND THE SURGERY TIME WAS NOT EXTENDED BY THIRTY MINUTES OR MORE.

  Patient problems: No Patient Involvement

  MAUDE report 7308854 ↗
• MalfunctionOct 31, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER , PRIOR TO USE ON PATIENT THE ANVIL CANNOT OPEN PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6991006 ↗

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-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-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-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-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-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-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-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-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT

…and 57 more.