AEON AESC45PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851574008981), received between Oct 1, 2022 and Mar 23, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Firing Problem

  THE AEON¿ ENDOSCOPIC STAPLER CONSISTS OF A HANDLE AND RELOAD. DURING A THORACIC LOBECTOMY, AN AEON¿ ENDOSCOPIC STAPLER HANDLE WAS USED WITH A AESC45P RELOAD. AFTER FIRING ON THE BRONCHUS, THE SURGEON RECOGNIZED THAT ALL STAPLES WERE NOT CLOSED IN THE CORRECT "B" FORM. THE SURGEON NEEDED TO REPLACE THE INCORRECT STAPLE LINE WITH SUTURE. THE ISSUE RESULTED IN 20 ADDITIONAL MINUTES TO THE PROCEDURE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670099 ↗
• MalfunctionApr 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE AEON ENDOSTAPLER CONSISTS OF A HANDLE AND RELOAD. DURING A RIGHT UPPER LOBECTOMY, AN AEON RELOAD WAS USED ON THE BRONCHUS. AFTER THE FIRING, THE RELOAD COULD NOT BE RETRACTED. TO REMOVE THE RELOAD FROM THE TISSUE, THE SURGERY WAS CONVERTED TO AN OPEN APPROACH. NO FURTHER INTERVENTION, PATIENT COMPLICATIONS OR HARM ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059876 ↗
• MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE AEON ENDOSTAPLER CONSISTS OF A HANDLE AND RELOAD. DURING A RIGHT UPPER LOBECTOMY, AN AEON RELOAD WAS USED ON THE BRONCHUS. AFTER THE FIRING, THE RELOAD COULD NOT BE RETRACTED. TO REMOVE THE RELOAD FROM THE TISSUE, THE SURGERY WAS CONVERTED TO AN OPEN APPROACH. NO FURTHER INTERVENTION, PATIENT COMPLICATIONS OR HARM ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993842 ↗
• InjuryOct 1, 2022Mechanical Problem; Mechanical Problem

  DURING SURGERY, WHEN STAPLING THE BRONCHUS WITH AN AEON STAPLER WITH A 45 PURPLE RELOAD, THE STAPLER WOULD NOT RELEASE OFF THE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524768 ↗