AEON AESC45GRecalls & reported problems
Lexington Medical, Inc. · Endoscopic Stapler 45mm Curved Tip Reload 2.0mm/0.75mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851574008943), received between Aug 25, 2023 and Aug 25, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Form Staple” (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
- Failure to Form Staple1
Patient problems
- Bronchial Hemorrhage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2023Failure to Form Staple; Failure to Form Staple
FIVE 45 GREY CURVED RELOADS AND ONE 30 WHITE CURVED RELOAD WERE USED FOR A LOBECTOMY PROCEDURE THAT WAS PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE THE SURGEON FIRED THE RELOAD TO SEAL AN ARTERY, THE STAPLE LINE DID NOT FULLY SEAL THE ARTERY AND THE PATIENT BLED.
Patient problems: Bronchial Hemorrhage
MAUDE report 17626071 ↗
Other Staple, Implantable devices
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- 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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