RUBY Coil RBY2C0415-BRecalls & reported problems
Penumbra, Inc. · Ruby Standard, 4x15 · 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 00814548018584), received between Aug 14, 2020 and Aug 14, 2020 — 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.
MalfunctionAug 14, 2020Material Deformation; Material Deformation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE HOSPITAL TECHNICIAN ADVANCED TOO BIG OF A PORTION OF THE PUSHER ASSEMBLY THROUGH THE INTRODUCER SHEATH. AN ATTEMPT WAS MADE TO ADVANCE ANOTHER RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10408500 ↗
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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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