AEON AESR60RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851574008660), received between Apr 5, 2022 and Sep 22, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (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. 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.

• MalfunctionSep 22, 2026Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859580 ↗
• MalfunctionDec 2, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  AN AEON ENDOSTAPLER 3.25MM/60MM ORANGE RELOAD WAS USED WITH AN AEON ENDOSTAPLER HANDLE - LONG IN A SLEEVE GASTRECTOMY PROCEDURE. THE PROCEDURE TOOK PLACE ON (B)(6) 2022 AND LEXINGTON MEDICAL WAS MADE AWARE OF THE EVENT ON NOVEMBER 2, 2022. THE STAPLER CUT BUT DID NOT STAPLE. NO PATIENT HARM.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 15909148 ↗
• InjuryOct 25, 2022Use of Device Problem; Use of Device Problem

  AN AEON ENDOSTAPLER 3.25MM/60MM ORANGE RELOAD WAS USED IN A GASTRIC BYPASS PROCEDURE BY DR. (B)(6) ON (B)(6) 2022. AN ORANGE RELOAD WAS SUCCESSFULLY FIRED TRANSVERSE ACROSS THE STOMACH. THE STAPLER WAS RELOADED WITH AN ORANGE RELOAD. AFTER THE STAPLER CLAMPED DOWN, THE USER HAD TO APPLY EXCESS FORCE TO FIRE. A POP WAS HEARD. THE USER TRIED TO ABORT THE RELOAD BUT WAS UNABLE TO. AFTER COMPLETION OF FIRING AND RETRACTION THERE WERE NO STAPLES FORMED, AND A HOLE WAS LEFT IN THE PATIENT'S STOMACH. IT WAS SUTURED TO REPAIR. ADDITIONAL RELOADS WERE USED ON THE SAME HANDLE TO COMPLETE THE CASE. THE SURGERY WAS DELAYED MORE THAN 30 MINUTES.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 15670578 ↗
• MalfunctionApr 5, 2022Mechanical Problem; Mechanical Problem

  AN AEON ENDOSTAPLER 3.25MM/60MM ORANGE RELOAD WAS USED WITH AN AEON ENDOSTAPLER HANDLE MEDIUM IN A LOW ANTERIOR RESECTION PROCEDURE BY THE PHYSICIAN ON (B)(6) 2022. THE PHYSICIAN FIRED THE RELOAD ACROSS THE FIRST STAPLE LINE AT FULL ARTICULATION. THE PHYSICIAN NOTED HIGH FORCE AND HEARD A CRACK SOUND FROM THE HANDLE. THE RETRACTION KNOB WAS THEN UNABLE TO BE PULLED BACK AND THE RELOAD REMAINED CLAMPED ON THE TISSUE. THE RELOAD WAS REMOVED BY STAPLING/CUTTING. SURGERY WAS DELAYED BY MORE THAN 30 MINUTES. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018387 ↗