Endo GIA UltraRecalls & reported problems across all models

We found 3 models of Endo GIA Ultra by Covidien LP in the FDA's device registry (GUDID). Together they are named in 15,650 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2016 and Sep 30, 2026 — classified as 7 deaths, 833 injuries, 14,810 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (9,632 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Endo GIA Ultra problems

Endo GIA Ultra models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Endo GIA Ultra EGIAUSTND

  STAPLE, IMPLANTABLE
  5 deaths9,730 reports
• Endo GIA Ultra EGIAUSHORT

  STAPLE, IMPLANTABLE
  2 deaths3,011 reports
• Endo GIA Ultra EGIAUXL

  STAPLE, IMPLANTABLE
  2,909 reports

Recent Endo GIA Ultra adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Retraction Problem

  It was reported that during a thoracoscopic lobectomy for a pulmonary nodule, while cutting using the stapler, staples fired abnormally, staples failed to form, and the stapler was difficult to retract, which impeded the procedure. A new stapler were used to complete the surgery, and the patient returned safely to the ward. The event resulted in a second intraoperative incision and increased bleeding and surgical risks.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50941771 ↗
• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: Insufficient Information

  MAUDE report 50937066 ↗
• MalfunctionSep 29, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936784 ↗
• MalfunctionSep 29, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935559 ↗
• MalfunctionSep 29, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934071 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: Laceration(s)

  MAUDE report 50923741 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: Tissue Breakdown

  MAUDE report 50923240 ↗
• MalfunctionSep 28, 2026Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917936 ↗
• MalfunctionSep 28, 2026Failure to Fire

  According to the reporter, intra-operatively of a laparoscopic appendectomy, during the transection of the ileocecal region, the sur geon was able to press the green button and squeeze the handle, but the device did not fire. Another device was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912259 ↗
• MalfunctionSep 23, 2026Failure to Fire

  According to the reporter, during a partial lung resection, at the time of parenchymal resection, the lung parenchyma was clamped with a black reload, and an attempt was made to fire, but the staple did not advance. It was noted that the staple came out around the proximal side of the cartridge's jaw. The cartridge and handle were replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864737 ↗
• MalfunctionSep 23, 2026Failure to Fire

  According to the reporter, during a procedure, two handles could not be squeezed and the device failed to fire despite the jaw being completely closed, after which manual suturing was performed as a staple line replacement. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864532 ↗
• MalfunctionSep 23, 2026Misfire

  According to the reporter, during a laparoscopic appendectomy procedure, the knife advanced first. 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 50864473 ↗
• MalfunctionSep 23, 2026Failure to Fire

  According to the reporter, during a procedure, two handles could not be squeezed and the device failed to fire despite the jaw being completely closed, after which manual suturing was performed as a staple line replacement. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864420 ↗
• 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 50863179 ↗
• MalfunctionSep 23, 2026Human-Device Interface Problem

  It was reported that during a laparoscopic pulmonary resection procedure, the stapler was unable to fire. The surgeon was unable to press the green button or squeeze the handle. The product was replaced to resolve the issue. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863157 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall
• Puritan Bennett119 models · 3,169 reports · 18 recalls