Apollo System APP1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548012711), received between Feb 17, 2016 and Dec 30, 2016 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (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.

• MalfunctionDec 30, 2016Aspiration Issue; Device Operates Differently Than Expected; Aspiration Issue; Device Operates Differently Than Expected

  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 6215857 ↗
• MalfunctionFeb 17, 2016Device Operational Issue; Pumping Problem; Device Operational Issue; Pumping Problem

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO PUMP. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE APOLLO PUMP WAS NOT REACHING ITS MAXIMUM POWER AND FLUCTUATED BETWEEN -26 AND -28 IN/HG. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME APOLLO PUMP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5442768 ↗
• MalfunctionFeb 17, 2016Device Operational Issue; Pumping Problem; Device Operational Issue; Pumping Problem

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO PUMP. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE APOLLO PUMP WAS NOT REACHING ITS MAXIMUM POWER AND FLUCTUATED BETWEEN -26 AND -28 IN/HG. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME APOLLO PUMP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5442703 ↗