AEON AESR60TRecalls & reported problems
Lexington Medical, Inc. · Endoscopic Stapler 60mm 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851574008820), received between May 7, 2019 and May 7, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Advance” (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 Advance1
- Retraction Problem1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2019Retraction Problem; Failure to Advance
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY THE RELOAD REMAINED CLAMPED DURING THE SECOND FIRING, THE RELOAD JUMPED MID FIRING. RELOAD COULD NOT BE ADVANCED OR RETRACTED. RELOAD WAS REMOVED BY STAPLING. STAPLING COMPLETED AS GASTRIC BYPASS PROCEDURE.
Patient problems: No Information
MAUDE report 8586249 ↗
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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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