GIA GIA60XTSRecalls & reported problems
Covidien LP · Black Stapler with Tri-Staple Technology · Class 2
All models of GIA (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521723573), received between Jun 19, 2025 and Mar 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (2 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, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Fire2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN OPEN WEDGE RESECTION ON THE LUNGS, THE TWO OPEN STAPLERS DID NOT FIRE. THE DEVICE WAS REPLACED, AND ANOTHER OPEN STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24723734 ↗MalfunctionMar 30, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN OPEN WEDGE RESECTION ON THE LUNGS, THE TWO OPEN STAPLERS DID NOT FIRE. THE DEVICE WAS REPLACED, AND ANOTHER OPEN STAPLER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24722526 ↗MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN ILECTOMY, WHEN THE LINEAR STAPLER WAS PLACED ON THE SURGICAL TABLE, THE BLACK INSERT FELL OFF, CAUSING THE BLADE TO SHIFT. ANOTHER STAPLER WAS PLACED ON THE TABLE, AND THE SAME ISSUE OCCURRED. A PURPLE 60-GAUGE REFILL WAS ALSO USED, AND THERE WAS INCOMPLETE STAPLE LINE; ONE END OF THE HANDLE REMAINED OPEN. A MANUAL SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293165 ↗
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- ECHELON FLEX PSEE60AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE1 recall13 deaths3,294 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
- Endo GIA EGIA45AMTCovidien LP · STAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
- ENDOPATH ATS45Ethicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE2 deaths2,046 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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