Tri-Staple 2.0 SIG45AVRecalls & reported problems
Covidien LP · Gray Intelligent Reload;Gray Extra Thin/Vascular Intelligent Reload;For use with Signia (TM) stapling system · Class 2 · Implant
All models of Tri-Staple 2.0 (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521808997), received between Aug 8, 2023 and Aug 8, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).
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.
Most reported problems
Device problems
- Device Displays Incorrect Message1
- Failure to Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2023Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, FIRING OVER DORSAL VENOUS COMPLEX, WHEN THE RELOAD WAS LOADED TO THE POWER HANDLE, FIRING MODE TURNED OFF, THE RELOAD WAS READJUSTED, AND THEN AFTER THAT, THE RELOAD WAS LISTED AS USED. THERE WERE NO STAPLES DEPLOYED ON RELOAD THAT WAS VISIBLE. WHEN A NEW RELOAD WAS USED, THE STATUS CHANGED TO UNUSED (THREE GREEN BARS). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17483830 ↗
Other Staple, implantable devices
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- 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 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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