Apollo System APTUBE1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814548013602), received between Feb 26, 2016 and Dec 6, 2016 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Out-Of-Box Failure” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE TO TREAT A VENTRICULAR HEMORRHAGE USING THE APOLLO SYSTEM. DURING THE PROCEDURE, THE WAND WAS MAKING A LOT OF NOISE AND SEEMED TO NOT BE WORKING WELL. IT WAS NOTED THAT THE VENTRICULAR CLOT WAS THICK AND THE WAND DID NOT SEEM TO BREAK IT WELL AND THE ASPIRATION SEEMED LESS THAN WHAT WAS EXPECTED. THE NURSE THEN REMOVED THE APOLLO IRRIGATION TUBING (IRRIGATION TUBING) FROM THE CONSOLE AND COVERED THE ASPIRATION PORT WITH A FINGER AND NOTICED THAT THE DIAL WAS AT -20 INHG. WHEN THE IRRIGATION TUBING WAS CONNECTED BACK TO THE CONSOLE, THE ASPIRATION PRESSURE WAS AT ¿25 INHG. IT WAS REPORTED THAT THE WAND ALSO MADE A SCREECHING HIGH PITCH NOISE; THEREFORE, IT WAS REMOVED AND A NEW WAND WAS OPENED. THE NURSE THEN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO CONNECT THE IRRIGATION TUBING TO THE NEW WAND AND CONSEQUENTLY, THE IRRIGATION TUBING BECAME CONTAMINATED. THEREFORE, THE IRRIGATION TUBING WAS REMOVED AND A NEW IRRIGATION TUBING WAS OPENED. IT WAS ALSO NOTED THAT THE PROTECTIVE CAP (RED WITH A WING SHAPED END) WAS VERY DIFFICULT TO REMOVE. AFTER THAT, THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND THERE WAS NO REPORT OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6149900 ↗
• MalfunctionJun 2, 2016Disconnection; Out-Of-Box Failure; Device Misassembled During Manufacturing /Shipping; Disconnection; Out-Of-Box Failure; Device Misassembled During Manufacturing /Shipping

  DURING PREPARATION FOR A MICRONEUROSURGERY PROCEDURE, THE TECHNICIAN NOTICED THAT THE APOLLO IRRIGATION TUBING (TUBING) WAS DISCONNECTED INTO TWO PIECES UPON REMOVAL FROM THE PACKAGING. THE DISCONNECTED TUBING WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 5696062 ↗
• MalfunctionMar 8, 2016Defective Component; Out-Of-Box Failure; Failure to Disconnect; Defective Component; Out-Of-Box Failure; Failure to Disconnect

  DURING PREPARATION FOR A MICRONEUROSURGERY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE RED CAP OF THE APOLLO IRRIGATION TUBING (TUBING) WOULD NOT TWIST OFF AND THEREFORE, THE MALE END COULD NOT BE USED. THE DEFECTIVE TUBING WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 5485931 ↗
• MalfunctionFeb 26, 2016Leak/Splash; Device Difficult to Setup or Prepare; Use of Device Problem; Leak/Splash; Device Difficult to Setup or Prepare; Use of Device Problem

  DURING PREPARATION FOR A MICRONEUROSURGERY PROCEDURE, AFTER CONNECTING THE APOLLO IRRIGATION TUBING TO THE APOLLO WAND AND ACTIVATING THE GENERATOR TO FLUSH THE SYSTEM, IT WAS NOTICED THAT THE IRRIGATION TUBING WAS LEAKING AT THE CONNECTION BETWEEN THE DISTAL FEMALE LUER LOCK AND THE DISTAL MALE TO MALE SWIVEL LUER CONNECTOR. THE PHYSICIAN TIGHTENED THE CONNECTION AND THE LEAK WAS STOPPED. THE PROCEDURE WAS COMPLETED USING THE SAME IRRIGATION TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 5464837 ↗