AEON AESH160Recalls & reported problems
Lexington Medical, Inc. · Endoscopic Stapler Handle - Medium · 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 00851574008004), received between Sep 13, 2023 and Sep 13, 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.
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.
MalfunctionSep 13, 2023Retraction Problem; Retraction Problem
AN AEON ENDOSTAPLER HANDLE MEDIUM WAS USED WITH A 45 PURPLE RELOAD DURING A LOBECTOMY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE THE AESR45P WAS FIRED ON THE BRONCHUS, AFTER THE FIRING THE RELOAD WOULD NOT UNCLAMP AND RETRACT FROM THE TISSUE. THE SURGEON NEEDED TO USE A SCALPEL TO RELEASE THE RELOAD AND SUTURE THE BRONCHUS. NO PATIENT HARM. DURING A FOLLOW-UP CONVERSATION, THE SURGEON STATED THAT THE TISSUE HAD BEEN PREVIOUSLY IRRADIATED AND WAS SIGNIFICANTLY INFLAMED. THEY ALSO SAID THE TISSUE WAS THICK AND IN HINDSIGHT, A 45MM BLACK RELOAD MAY HAVE BEEN MORE APPROPRIATE FOR THE TISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741105 ↗
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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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