Apollo System AP9-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548016344), received between Jul 6, 2017 and May 8, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2018Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO WAND (WAND). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE WAND WAS LEAKING FROM THE CONNECTION TO THE APOLLO GENERATOR DURING THE FOOT PEDAL ACTIVATION. IT WAS ALSO REPORTED THAT THE WIRE WITHIN THE WAND STOPPED VIBRATING TOWARD THE END OF THE PROCEDURE. THE PHYSICIAN WAS ABLE TO REMOVE MOST OF THE CLOT AND THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7496576 ↗
• MalfunctionOct 25, 2017Leak/Splash; Leak/Splash

  DURING PREPARATION FOR A MICRONEUROSURGERY PROCEDURE, THE PHYSICIAN NOTICED THE APOLLO WAND (WAND) WAS LEAKING FROM THE CONNECTION TO THE APOLLO GENERATOR. THE DAMAGED WAND WAS NOTICED PRIOR TO USE IN THE PATIENT AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW WAND.

  Patient problems: No Patient Involvement

  MAUDE report 6976979 ↗
• MalfunctionAug 11, 2017Mechanical Problem; Out-Of-Box Failure; Defective Device; Mechanical Problem; Out-Of-Box Failure; Defective Device

  DURING PREPARATION FOR A MICRONEUROSURGERY PROCEDURE, THE PHYSICIAN NOTICED THAT TWO APOLLO WANDS (WAND) WERE NOT VIBRATING. THE DEFECTIVE WANDS WERE FOUND PRIOR TO USE AND THEREFORE, WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW WAND.

  Patient problems: No Patient Involvement

  MAUDE report 6790637 ↗
• MalfunctionAug 11, 2017Mechanical Problem; Out-Of-Box Failure; Defective Device; Mechanical Problem; Out-Of-Box Failure; Defective Device

  DURING PREPARATION FOR A MICRONEUROSURGERY PROCEDURE, THE PHYSICIAN NOTICED THAT TWO APOLLO WANDS (WAND) WERE NOT VIBRATING. THE DEFECTIVE WANDS WERE FOUND PRIOR TO USE AND THEREFORE, WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW WAND.

  Patient problems: No Patient Involvement

  MAUDE report 6790635 ↗
• MalfunctionJul 6, 2017Mechanical Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  DURING PREPARATION FOR A MICRO NEUROSURGERY, THE HOSPITAL STAFF NOTICED THAT THE APOLLO WAND (WAND) WAS NOT WORKING PROPERLY UPON ATTACHING IT TO THE APOLLO GENERATOR AND TESTING THE APOLLO SYSTEM. IT WAS REPORTED THAT THE WIRE WITHIN THE WAND WAS NOT ACTIVATED WHEN DEPRESSING THE APOLLO GENERATOR FOOT PEDAL (FOOT PEDAL) ON THE APOLLO SYSTEM. THEREFORE, THE PHYSICIAN OPENED A NEW WAND, TESTED IT AND USED IT TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 6691748 ↗