Apollo SystemRecalls & reported problems across all models

We found 7 models of Apollo System by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2015 and May 8, 2018 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Apollo System problems

Apollo System models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Apollo System AP9

  ENDOSCOPE, NEUROLOGICAL
  10 reports
• Apollo System AP9-A

  Endoscope, Neurological
  5 reports
• Apollo System AP7

  ENDOSCOPE, NEUROLOGICAL
  4 reports
• Apollo System APTUBE1

  ENDOSCOPE, NEUROLOGICAL
  4 reports
• Apollo System APP1

  ENDOSCOPE, NEUROLOGICAL
  3 reports
• Apollo System APG1

  ENDOSCOPE, NEUROLOGICAL
  1 report
• Apollo System AP7-A

  Endoscope, Neurological
  1 report

Recent Apollo System adverse event reports

The 15 most recent reports across all models, 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 21, 2017Detachment Of Device Component; Material Rupture; Material Separation; Detachment Of Device Component; Material Rupture; Material Separation

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRA-CEREBRAL HEMORRHAGE (ICH) USING AN APOLLO WAND (WAND). DURING THE PROCEDURE, AFTER A FEW MINUTES OF USE, A LOUD NOISE WAS HEARD. THE PENUMBRA SALES REPRESENTATIVE INSPECTED THE WAND¿S CONNECTION TO THE APOLLO GENERATOR (GENERATOR), AND FOUND THAT THE BLACK CONNECTOR HAD BECOME LOOSE DUE TO THE VIBRATION OF THE MACHINE. THE SALES REPRESENTATIVE TIGHTENED THE BLACK CONNECTOR, AND FELT THAT IT HAD BECOME VERY HOT. THE BLACK CONNECTOR WAS UNABLE TO STAY TIGHT; THEREFORE, THE SALES REPRESENTATIVE HELD THE BLACK CONNECTOR IN PLACE AS THE PROCEDURE CONTINUED. THE NOISE CONTINUED AND THERE WAS STILL A CONSIDERABLE AMOUNT OF HEAT AT THE BLACK CONNECTOR, AND SO AT THIS POINT THE PHYSICIAN REMOVED THE WAND FROM THE PATIENT AND FOUND THAT THE VIBRATION WIRE WAS PROTRUDING AND WAS EXPOSED OUTSIDE OF THE TIP OF THE WAND. THE WAND WAS THEREFORE NOT REUSED, AND THE PROCEDURE WAS COMPLETED USING A NEW WAND AND THE SAME GENERATOR. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6807338 ↗
• 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 ↗
• 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, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 10, 2016Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO GENERATOR (GENERATOR) AND APOLLO WANDS (WAND). DURING THE PROCEDURE, WHILE USING THE WAND THE PHYSICIAN NOTICED THERE WAS A LEAK AT THE HUB OF THE WAND AND, THEREFORE, SWITCHED TO A NEW WAND. HOWEVER, THE PHYSICIAN NOTICED THAT THE HUB OF THE NEW WAND WAS LEAKING AS WELL. THE PHYSICIAN COMPLETED THE PROCEDURE USING THIS WAND DESPITE THE LEAK. THE PHYSICIAN ALSO NOTICED THE CORD OF THE APOLLO GENERATOR FOOT PEDAL WAS SEVERED IN HALF, AND COMPLETED THE PROCEDURE BY TAPING THE CORD BACK TOGETHER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6094727 ↗

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