RUBY Coil RBY2C1440-BRecalls & reported problems
Penumbra, Inc. · Ruby Standard, 14x40 · Class 2
All models of RUBY Coil (90)
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 00814548019109), received between Feb 26, 2021 and Feb 26, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionFeb 26, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LPS, RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WAS ADVANCED HALF-WAY THROUGH THE MICROCATHETER WHEN IT BECAME DIFFICULT TO ADVANCE AND SUBSEQUENTLY, THE PUSHER WIRE BECAME KINKED. THEREFORE, THE PACKING COIL LP WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH A RUBY COIL AND TWO MORE PACKING COIL LPS. THEREFORE, THESE COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11388769 ↗
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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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