Apollo System AP7Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814548013596), received between Mar 3, 2016 and Dec 2, 2016 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 2, 2016Complete Blockage; Fluid/Blood Leak; Complete Blockage; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE TREATING AN INTRACRANIAL HEMORRHAGE (ICH) USING APOLLO WANDS (WANDS). DURING THE PROCEDURE, WHILE USING THE WAND, THE PHYSICIAN NOTICED THERE WAS A LEAK AT THE HUB OF THE WAND AND IT BECAME CLOGGED AND UNUSABLE. THE WAND WAS THEREFORE REMOVED AND THE PROCEDURE WAS CONTINUED USING A NEW WAND. THE PHYSICIAN REPORTED THAT ALTHOUGH THE NEW WAND WAS LEAKING AS WELL; IT WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6143541 ↗
• MalfunctionDec 2, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE TREATING AN INTRACRANIAL HEMORRHAGE (ICH) USING APOLLO WANDS (WANDS). DURING THE PROCEDURE, WHILE USING THE WAND, THE PHYSICIAN NOTICED THERE WAS A LEAK AT THE HUB OF THE WAND AND IT BECAME CLOGGED AND UNUSABLE. THE WAND WAS THEREFORE REMOVED AND THE PROCEDURE WAS CONTINUED USING A NEW WAND. THE PHYSICIAN REPORTED THAT ALTHOUGH THE NEW WAND WAS LEAKING AS WELL; IT WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6143209 ↗
• MalfunctionMar 3, 2016Complete Blockage; Device Operational Issue; Complete Blockage; Device Operational Issue

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO WAND (WAND). DURING THE PROCEDURE, THE PHYSICIAN REMOVED THE WAND FROM THE PATIENT IN ORDER TO MAKE ADJUSTMENTS TO HIS ENDOSCOPE. AFTER THE TECHNICIAN PLACED THE WAND ON THE STERILE MAYO STAND, IT WAS NOTICED THAT THE WIRE INSIDE THE WAND'S SHAFT WAS PROTRUDING OUT. THEREFORE, THE PHYSICIAN CONTINUED THE PROCEDURE USING A NEW WAND; HOWEVER, THIS NEW WAND BECAME CLOGGED AND STOPPED FUNCTIONING. THE PHYSICIAN WAS UNABLE TO CLEAR THE CLOG IN THE WAND BECAUSE THE CLOTS WERE EXTREMELY HARD. THEREFORE, THE WAND WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW WAND. AFTER THE PROCEDURE, THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT WHERE SHE WAS HYPOTENSIVE AND NOT SATURATING WELL. THIS WAS NOT AN ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE PROCEDURE BECAUSE THE PATIENT WAS VERY SICK EVEN BEFORE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5477557 ↗
• MalfunctionMar 3, 2016Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO WAND (WAND). DURING THE PROCEDURE, THE PHYSICIAN REMOVED THE WAND FROM THE PATIENT IN ORDER TO MAKE ADJUSTMENTS TO HIS ENDOSCOPE. AFTER THE TECHNICIAN PLACED THE WAND ON THE STERILE MAYO STAND, IT WAS NOTICED THAT THE WIRE INSIDE THE WAND'S SHAFT WAS PROTRUDING OUT. THEREFORE, THE PHYSICIAN CONTINUED THE PROCEDURE USING A NEW WAND; HOWEVER, THIS NEW WAND BECAME CLOGGED AND STOPPED FUNCTIONING. THE PHYSICIAN WAS UNABLE TO CLEAR THE CLOG IN THE WAND BECAUSE THE CLOTS WERE EXTREMELY HARD. THEREFORE, THE WAND WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW WAND. AFTER THE PROCEDURE, THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT WHERE SHE WAS HYPOTENSIVE AND NOT SATURATING WELL. THIS WAS NOT AN ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE PROCEDURE BECAUSE THE PATIENT WAS VERY SICK EVEN BEFORE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5477542 ↗