AEON AESR60PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00851574008721), received between Nov 1, 2022 and Aug 18, 2025 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE AEON ENDOSTAPLER SYSTEM CONSISTS OF A HANDLE AND RELOAD. DURING A THORACIC WEDGE RESECTION PROCEDURE, IT WAS REPORTED THAT THE SIDE PIN OF A AESR60P RELOAD HAD COME LOOSE AND FELL INTO THE PATIENT SITE. THE SURGEON WAS ABLE TO RETRIEVE THE PIN OUT OF THE PATIENT. IT WAS REPORTED THAT THE STAPLE LINE PERFORMED WELL. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833431 ↗
• MalfunctionJul 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE AEON ENDOSCOPIC STAPLER CONSISTS OF A HANDLE AND RELOAD. DURING A THORACIC LOBECTOMY, THE SURGEON WAS USING AESR60P RELOADS ON NORMAL LUNG PARENCHYMA. IT WAS REPORTED THAT THE PIN BETWEEN THE CATRIDGE AND THE ANVIL HAD COME LOOSE AND FALLEN INTO THE SITE. THE SURGEON WAS ABLE TO RETRIEVE THE COMPONENT OUT OF THE PATIENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22581695 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AEON ENDOSTAPLER 4.0MM/60MM PURPLE RELOAD WAS USED IN A SLEEVE GASTRECTOMY PROCEDURE BY DR. (B)(6) ON (B)(6) 2022. TWO AEON RELOADS HAD ALREADY BEEN FIRED (AESR60P) WHEN THE DOCTOR WAS ABOUT TO FIRE THE THIRD RELOAD. A STRANGE SOUND WAS INITIALLY HEARD DURING FIRING. AFTER COMPLETE FIRING AND RETRACTION OF THE RELOAD, IT WAS OBSERVED THAT NO STAPLES WERE RELEASED. THE SURGERY WAS DELAYED MORE THAN 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 15707668 ↗