AEON AETH160Recalls & reported problems
Lexington Medical, Inc. · Endoscopic Stapler Plus Handle Medium · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851574008363), received between Nov 14, 2025 and Apr 22, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Retraction Problem2
Patient problems
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Retraction Problem
THE AEON¿ ENDOSCOPIC STAPLER CONSISTS OF A HANDLE AND RELOAD. DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, AN AETH160 HANDLE WAS USED ALONG WITH AN UNSPECIFIED RELOAD. AFTER THE FIRING, THE RELOAD COULD NOT BE RETRACTED. THE TISSUE WAS ABLE TO BE REMOVED FROM THE RELOAD. NO ADDITIONAL SURGERY WAS NECESSARY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953078 ↗MalfunctionNov 14, 2025Retraction Problem; Retraction Problem
THE AEON¿ ENDOSCOPIC STAPLER CONSISTS OF A HANDLE AND RELOAD. DURING A ESOPHAGECTOMY PROCEDURE, AN AETH160 HANDLE WAS USED ALONG WITH AN AESR60P RELOAD. AFTER THE FIRING, THE RELOAD COULD NOT BE RETRACTED. THE TISSUE WAS ABLE TO BE REMOVED FROM THE RELOAD, RESULTING IN A MINOR INJURY. NO ADDITIONAL SURGERY WAS NECESSARY. THE PATIENT RECEIVED ENDOVAC THERAPY, NO FURTHER PATIENT HARM WAS REPORTED.
Patient problems: Laceration(s)
MAUDE report 23556380 ↗
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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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