AEON AESC45WRecalls & reported problems
Lexington Medical, Inc. · Endoscopic Stapler 45mm Curved Tip Reload 2.5mm/1.0mm · Class 2
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 00851574008110), received between Nov 6, 2023 and Nov 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Retraction Problem” (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.
Reports received per month
Most reported problems
Device problems
- Retraction Problem1
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.
MalfunctionNov 6, 2023Retraction Problem; Retraction Problem
AN AEON ENDOSTAPLER HANDLE SHORT (AESH060) WAS USED WITH A WHITE AESC45W RELOAD IN A LIVER RESECTION PROCEDURE PERFORMED BY THE DR. ON (B)(6) 2023. DURING THE PROCEDURE WHEN FIRING THE AESC45W RELOAD THE RELOAD FIRED BUT DID NOT OPEN. THE SURGEON WAS ABLE TO GET THE RELOAD OFF THE TISSUE AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18080346 ↗
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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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