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Apollo System AP7-ARecalls & reported problems

Penumbra, Inc. · Apollo Wand, Short · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548016351), received between Aug 21, 2017 and Aug 21, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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

Device problems

  • Detachment Of Device Component1
  • Material Rupture1
  • Material Separation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • 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 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.