EEA TRIEEA25XTRecalls & reported problems
Covidien LP · Black Extra Thick Circular Stapler with Tri-Staple Technology · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521593015), received between Jan 22, 2025 and Oct 20, 2025 — classified as 5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Fire2
- Break1
- Detachment of Device or Device Component1
- Failure to Form Staple1
- Misfire1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Failure to Anastomose1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A PROCEDURE, THE CIRCULAR STAPLER DID NOT FIRE DURING USE. THE DEVICE WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23338301 ↗MalfunctionMar 19, 2025Break; Misfire; Break; Misfire
IT WAS REPORTED THAT DURING A PROCEDURE, SPECIFICALLY INVOLVING AN INSTRUMENT BREAKAGE, AND FIRING ISSUES.
Patient problems: Insufficient Information
MAUDE report 21647304 ↗MalfunctionMar 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE USE OF A CIR STPLR TRIEEA25XT BLK EXTHK, THE ANVIL BROKE. THE BROKEN PART DISENGAGED, BUT NO PIECES FELL INTO THE PATIENT CAVITY, AND AN X-RAY WAS NOT NEEDED TO LOCATE COMPONENTS. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW TRIEEA25XT STAPLER. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634659 ↗MalfunctionFeb 6, 2025Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE. ANOTHER DEVICE WAS REPLACED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 21324420 ↗MalfunctionJan 22, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A SIGMOIDECTOMY WITH LOOP ILEOSTOMY, USING THE CIR STPLR TRIEEA25XT BLK EXTHK, A BOWEL LEAK OCCURRED, AND THE SURGICAL TIME WAS EXTENDED. THE DEVICE WAS APPLIED AT THE END OF THE PROCEDURE. SUTURING WAS PERFORMED AS A STAPLE LINE REINFORCEMENT TO ADDRESS THE BOWEL LEAK.
Patient problems: Failure to Anastomose
MAUDE report 21210109 ↗
Other Staple, implantable devices
- Endo GIA EGIA60AMTCovidien LP · STAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA Ultra EGIAUSTNDCovidien LP · STAPLE, IMPLANTABLE5 deaths9,730 reports
- Signia SIGPHANDLECovidien LP · STAPLE, IMPLANTABLE1 recall3 deaths5,356 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.