Endo GIA EGIA45AVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,583 adverse event reports that list this exact device (DI 10884523003178), received between Nov 14, 2016 and Sep 29, 2026 — classified as 7 deaths, 216 injuries, 1,360 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (941 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 1,583 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Form Staple

  It was reported that during laparoscopic thoracoscopic left lower lobectomy surgery, when severing the lower lobe vein, after the staplers were fired, there was poor staple formation and bleeding occurred. Since it was not cut from the root, another reload was triggered again next to the previous shot; however, the same bleeding persisted. Finally, the procedure was completed by hand suturing.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50933802 ↗
• MalfunctionSep 23, 2026Failure to Fire

  According to the reporter during a gastric bypass procedure, the manual handle with reload did not fire. The surgeon was able to press the green safety button but was unable to squeeze the handle. The handle and reload were replaced to resolve the issue and the procedure was extended by approximately 15 minutes to complete the procedure. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863201 ↗
• MalfunctionSep 21, 2026Failure to Form Staple

  It was reported that during a single-port video-assisted thoracoscopic lobectomy, the device had poor staple formation at the distal end and an incomplete distal staple line. The staple line was reinforced with suturing.

  Patient problems: Tissue Breakdown

  MAUDE report 50840193 ↗
• MalfunctionSep 17, 2026Failure to Form Staple

  According to the reporter, in a thoracoscopic lobectomy, the lung tissue was clamped and the stapler was fired but the staples burst out. Another handle and reload were used to resolve the issue.

  Patient problems: Tissue Breakdown

  MAUDE report 50800446 ↗
• MalfunctionAug 25, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439465 ↗
• MalfunctionAug 24, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418700 ↗
• MalfunctionJun 11, 2026Retraction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLER WAS FIRED WITH THE BEIGE RELOAD, HOWEVER THE KNIFE BLADE FAILED TO RETRACT RESULTING IN A STUCK HANDLE.

  Patient problems: Insufficient Information

  MAUDE report 25473996 ↗
• MalfunctionJun 4, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS, TWO RELOADS DID NOT CLOSE WHEN TISSUE WAS PLACED IN BETWEEN THE JAWS. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25395480 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY ON A GASTRIC BYPASS, THE PATIENT WAS READMITTED TO THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 25104430 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY ON A GASTRIC BYPASS, THE PATIENT WAS READMITTED TO THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 25094903 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY ON A GASTRIC BYPASS, THE PATIENT WAS READMITTED TO THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 25094800 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY ON A GASTRIC BYPASS, THE PATIENT WAS READMITTED TO THE HOSPITAL. THE DEVICE WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 25073198 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS PROCEDURE, UPON RELOADING AFTER FIRING, IT DETACHED FROM THE SHAFT AND HAD TO BE CAREFULLY EXTRACTED TO AVOID DAMAGING THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023121 ↗
• MalfunctionApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GASTROINTESTINAL BLEEDING OCCURRED ON THE THIRD DAY AFTER GASTRIC BYPASS SURGERY, WITH STAPLE LINE BLEEDING AND MELENA BLEEDING NOTED. THE PATIENT WAS READMITTED TO THE HOSPITAL FOR TWO DAYS. AN ENDOSCOPY WAS PERFORMED, WHICH FOUND NO ACTIVE BLEEDING. PLASMA WAS ADMINISTERED AS A PROPHYLACTIC METHOD.

  Patient problems: Gastrointestinal Hemorrhage; Melena

  MAUDE report 24795401 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE OPERATED PATIENT PRESENTED A COMPLICATION IN THE POSTOPERATIVE BYPASS PROCEDURE, THE PATIENT DEVELOPED A GASTRIC LEAK, THE PATIENT ADMITTED TO THE ICU. A EXPLORATORY SURGERY PERFORMED. A MECHANICAL VENTILATION. VASOACTIVE DRUGS.

  Patient problems: Failure to Anastomose

  MAUDE report 24724367 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING GASTRIC BYPASS SURGERY, THE PATIENT EXPERIENCED GASTROINTESTINAL BLEEDING ON THE THIRD DAY POS T-PROCEDURE. THE PATIENT WAS READMITTED TO THE HOSPITAL FOR TWO DAYS AND PRESENTED WITH MELENA BLEEDING. AN ENDOSCOPY WAS PERFORMED, AND NO ACTIVE BLEEDING WAS OBSERVED AT THAT TIME. PLASMA WAS ADMINISTERED AS A PROPHYLACTIC METHOD.

  Patient problems: Gastrointestinal Hemorrhage; Melena

  MAUDE report 24708785 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING GASTRIC BYPASS SURGERY, THE PATIENT EXPERIENCED GASTROINTESTINAL BLEEDING ON THE THIRD DAY POS T-PROCEDURE. THE PATIENT WAS READMITTED TO THE HOSPITAL FOR TWO DAYS AND PRESENTED WITH MELENA BLEEDING. AN ENDOSCOPY WAS PERFORMED, AND NO ACTIVE BLEEDING WAS OBSERVED AT THAT TIME. PLASMA WAS ADMINISTERED AS A PROPHYLACTIC METHOD.

  Patient problems: Gastrointestinal Hemorrhage; Melena

  MAUDE report 24708780 ↗
• MalfunctionMar 25, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN END TO END ANASTOMOSIS, THE STAPLE LINE LEAKED. IT WAS NOTED THAT A MINOR METHYLENE BLUE STAINING WAS OBSERVED ALONG THE STAPLE LINE. A REINFORCING SUTURE WAS PLACED. A REPEAT BLUE DYE TEST WAS PERFORMED AND YIELDED A NEGATIVE RESULT.

  Patient problems: Failure to Anastomose

  MAUDE report 24685008 ↗
• MalfunctionMar 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN LEFT NEPHRECTOMY, WHILE ATTEMPTING TO STAPLE VASCULAR TISSUE,  THE THREE MANUAL STAPLERS DID NOT FIRE DESPITE THE SURGEON BEING ABLE TO PRESS THE GREEN SAFETY BUTTON AND SQUEEZE THE HANDLE. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 45 MINUTES DUE TO THESE FIRING ISSUES. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE SITUATION.

  Patient problems: Tissue Breakdown

  MAUDE report 24669083 ↗
• MalfunctionMar 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN LEFT NEPHRECTOMY, WHILE ATTEMPTING TO STAPLE VASCULAR TISSUE, THE THREE MANUAL STAPLERS DID NOT FIRE DESPITE THE SURGEON BEING ABLE TO PRESS THE GREEN SAFETY BUTTON AND SQUEEZE THE HANDLE. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 45 MINUTES DUE TO THESE FIRING ISSUES. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE SITUATION.

  Patient problems: Tissue Breakdown

  MAUDE report 24664462 ↗
• MalfunctionMar 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN LEFT NEPHRECTOMY, WHILE ATTEMPTING TO STAPLE VASCULAR TISSUE,  THE THREE MANUAL STAPLERS DID NOT FIRE DESPITE THE SURGEON BEING ABLE TO PRESS THE GREEN SAFETY BUTTON AND SQUEEZE THE HANDLE. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 45 MINUTES DUE TO THESE FIRING ISSUES. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE SITUATION.

  Patient problems: Tissue Breakdown

  MAUDE report 24661668 ↗
• MalfunctionMar 19, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, AFTER FIRING, STAPLE LINE LEAKAGE WAS FOUND WHEN PERFORMING METHYLENE BLUE TEST. SUTURING WAS PERFORMED AS A STAPLE LINE REINFORCEMENT YET LEAKAGE WAS STILL FOUND. WHEN A SECOND STITCH WAS PERFORMED, THE STAPLE LINE PASSED THE METHYLENE BLUE TEST. SURGICAL TIME WAS EXTENDED BY 15 TO 20 MINUTES AS A RESULT OF THE EVENT.

  Patient problems: Tissue Breakdown

  MAUDE report 24638104 ↗
• MalfunctionMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, THERE WAS BLEEDING AT THE STAPLE LINE. SUTURING AS A STAPLE LINE REINFORCEMENT WAS DONE TO RESOLVE THE ISSUE. THIS RESULTED IN EXTENDED SURGICAL TIME OF 15 MINUTES DUE TO BLEEDING AND MORE LIGATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24590445 ↗
• MalfunctionMar 11, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE PARTIALLY FIRED AND STOPPED FIRING. 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 24571940 ↗
• MalfunctionMar 11, 2026Failure to Cut

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS, THE RELOAD DID NOT CUT PROPERLY AFTER COMPLETE FIRING. THE ISSUE WAS RESOLVED BY CUTTING WITH A COLD INSTRUMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568275 ↗

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-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-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-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-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-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-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT

…and 58 more.