AEON AESR45RRecalls & reported problems
Lexington Medical, Inc. · Endoscopic Stapler 45mm Reload 3.25mm/1.5mm · Class 2
Data updated Oct 13, 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 00851574008806), received between Sep 13, 2023 and Sep 13, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AESH160 HANDLE AND AESR45R RELOAD WERE USED DURING A PROCEDURE ON AN ESOPHAGUS ON A (B)(6) 2023. THE TIP OF THE RELOAD INADVERTENTLY CONTACTED THE AORTA RESULTING IN A TEAR. THE SURGEON HAD TO CONVERT TO OPEN SURGERY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17741114 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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