AEON AESR45PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00851574008868), received between Apr 2, 2021 and Jul 31, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical 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 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.

• MalfunctionJul 31, 2023Mechanical Problem; Mechanical Problem

  AN AEON+ HANDLE SHORT WAS USED WITH AN AESR45P RELOAD IN A WEDGE RESECTION PERFORMED ON (B)(6) 2023. DURING THE LAST FIRING THE SURGEON HEARD A "POP" WHEN ATTEMPTING TO RETRACT THE HANDLE AND IT WOULD NOT MOVE. THE LEXINGTON REPRESENTATIVE ON SITE INSTRUCTED THE SURGEON TO JIGGLE THE TRIGGER AND RETRACTION KNOB. AFTER SEVERAL ATTEMPTS, THE SURGEON WAS STILL UNABLE TO RETRACT. HE ENDED UP DISSECTING AROUND THE LEFT SIDE OF THE RELOAD TO FREE IT. TISSUE WAS CUT FROM THE JAWS OF THE RELOAD WITHOUT CAUSING FURTHER HARM TO THE PATIENT OR ADDITIONAL BLEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424414 ↗
• MalfunctionJul 14, 2023Firing Problem; Firing Problem

  AN AEON AESH060 HANDLE WAS USED WITH AN AESR45P RELOAD ON THE THIRD FIRING OF A VATS WEDGE RESECTION ON THICK PARENCHYMA TISSUE. THE RELOAD WAS FIRED FULLY AND RETRACTED. UPON OPENING OF THE JAWS, THE SURGEON NOTED THERE WAS BLEEDING AND UNFORMED STAPLES ALONG THE STAPLE LINE.

  Patient problems: Bronchial Hemorrhage

  MAUDE report 17327065 ↗
• MalfunctionApr 2, 2021Mechanical Problem; Mechanical Problem

  AN AEON ENDOSCOPIC STAPLER 4.0MM/45MM PURPLE RELOAD WAS USED WITH AN AEON ENDOSCOPIC STAPLER HANDLE - MEDIUM IN A LOW ANTERIOR RESECTION PROCEDURE BY THE PHYSICIAN ON (B)(6) 2021. THE PHYSICIAN FIRED THE RELOAD ON THE RECTUM AND HEARD A CRACK SOUND DURING RETRACTION. THE ORANGE RETRACTION KNOB WAS PULLED BACK COMPLETELY, BUT 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: Insufficient Information

  MAUDE report 11608425 ↗