Apollo System AP9Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00814548013589), received between Aug 28, 2015 and Apr 18, 2017 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2017Complete Blockage; Complete Blockage

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO WAND (WAND). DURING THE PROCEDURE, THE WAND BECAME CLOGGED AND THE PHYSICIAN WAS UNABLE TO UNCLOG IT; THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW WAND. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6501581 ↗
• MalfunctionDec 30, 2016Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING THE APOLLO SYSTEM. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE APOLLO WAND (WAND) WAS LEAKING FROM THE CONNECTION POINT TO THE APOLLO GENERATOR (GENERATOR) AND ALSO FROM THE ROTATING HEMOSTASIS VALVE (RHV). THEREFORE, THE PHYSICIAN SWITCHED TO A NEW WAND. IT WAS ALSO NOTICED THAT THE REGULATOR KNOB ON THE APOLLO PUMP (PUMP) WAS NOT WORKING PROPERLY AND JUST SPUN AROUND WITHOUT MUCH EFFECT ON THE ASPIRATION POWER. HOWEVER, THE PROCEDURE WAS STILL COMPLETED USING THE SAME PUMP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6215851 ↗
• MalfunctionNov 11, 2016Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO WAND (WAND). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE WAND WAS LEAKING FROM THE CONNECTION TO THE APOLLO GENERATOR. THEREFORE, THE PHYSICIAN SWITCHED TO A NEW WAND AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6097307 ↗
• MalfunctionNov 10, 2016Leak/Splash; Device Damaged Prior to Use; Leak/Splash; Device Damaged Prior to Use

  DURING PREPARATION FOR A MICRONEUROSURGERY PROCEDURE, THE PHYSICIAN NOTICED THE APOLLO WAND (WAND) WAS LEAKING FROM THE HUB. 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 6094823 ↗
• MalfunctionJul 13, 2016Complete Blockage; Complete Blockage

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY USING AN APOLLO WAND (WAND). DURING THE PROCEDURE, THE WAND BECAME CLOGGED. THEREFORE, THE WAND WAS REMOVED AND THE PROCEDURE CONTINUED USING A NEW WAND. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5791453 ↗
• MalfunctionApr 26, 2016Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO WAND (WAND). DURING THE PROCEDURE, THE SONICATOR WIRE INSIDE THE WAND CAME OUT OF THE TIP OF THE WAND. THEREFORE, THE WAND WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW WAND. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5610330 ↗
• MalfunctionMar 24, 2016Material Integrity Problem; Material Protrusion/Extrusion; Material Integrity Problem; Material Protrusion/Extrusion

  DURING PREPARATION FOR A MICRONEUROSURGERY PROCEDURE, WHILE CLEANING THE TIP OF AN APOLLO WAND (WAND), THE HOSPITAL STAFF NOTICED THAT THE AGITATOR WIRE BECAME LOOSE AND WAS PULLED OUT. THE DAMAGED WAND WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW WAND.

  Patient problems: No Patient Involvement

  MAUDE report 5524573 ↗
• MalfunctionFeb 17, 2016Device Operates Differently Than Expected; Device Operational Issue; Device Operates Differently Than Expected; Device Operational Issue

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO WAND (WAND). DURING THE PROCEDURE, THE WAND STOPPED VIBRATING. THE PROCEDURE WAS COMPLETED USING A NEW WAND. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5442915 ↗
• MalfunctionOct 16, 2015Vibration; Device Operational Issue

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO WAND (WAND). DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS HOLDING DOWN THE PEDAL ON THE APOLLO FOOT SWITCH, THE VIBRATIONAL NOISE GENERATED FROM THE WAND WAS INTERMITTENT, CAUSING DECREASED WAND ACTUATION. THE PROCEDURE CONTINUED USING A NEW WAND. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5158043 ↗
• MalfunctionAug 28, 2015Kinked

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING A APOLLO WAND. DURING THE PROCEDURE, THE APOLLO WAND WAS FOUND KINKED ON THE TUBING AND WAS NOT USED AGAIN. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5040334 ↗