Apollo System APG1Recalls & reported problems
Penumbra, Inc. · Apollo Generator · Class 2
All models of Apollo System (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00814548012704), received between Nov 10, 2016 and Nov 10, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Deformation1
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.
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 ↗
Other ENDOSCOPE, NEUROLOGICAL devices
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- VS3-IR 174-0012Visionsense Ltd. · Endoscope, Neurological1 recall1 report
- Aurora® Surgiscope® ASX9/130Integra Lifesciences Corporation · Endoscope, neurological1 recall0 reports
- IMAGE1 S CONNECT TC201USKarl Storz GmbH & Co. KG · Endoscope, neurological34 reports
- Artemis AP28-APenumbra, Inc. · Endoscope, Neurological4 deaths31 reports
- NA 1688410105Stryker Corporation · Endoscope, neurological24 reports
- Apollo System AP9Penumbra, Inc. · ENDOSCOPE, NEUROLOGICAL10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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