RUBY Coil RBY2C0740-BRecalls & reported problems
Penumbra, Inc. · Ruby Standard, 7x40 · Class 2
Data updated Oct 13, 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 00814548018843), received between Aug 21, 2020 and Aug 21, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Deformation1
- Physical Resistance/Sticking1
- Premature 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, 2020Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE LANTERN TO THE TARGET VESSEL AND PROCEEDED TO ADVANCE APPROXIMATELY TWENTY CENTIMETERS OF THE RUBY COIL INTO THE TARGET VESSEL WITHOUT ISSUE. HOWEVER, WHILE ATTEMPTING TO ADVANCE THE LAST TWENTY CENTIMETERS OF THE RUBY COIL INTO THE VESSEL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE PUSHER ASSEMBLY BECAME KINKED. WHEN THE PHYSICIAN PULLED THE RUBY COIL BACK, THE COIL DETACHED IN THE LANTERN. THE PHYSICIAN ATTEMPTED TO FLUSH OUT THE RUBY COIL AS WELL AS PUSH THE COIL OUT OF THE LANTERN USING BOTH A .025 GUIDEWIRE AND A .018 GUIDEWIRE WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO REMOVE THE LANTERN; HOWEVER, WHILE RETRACTING THE LANTERN OUT OF THE PATIENT, IT FRACTURED APPROXIMATELY FORTY CENTIMETERS DISTAL TO THE HUB. THE PHYSICIAN REMOVED THE CATHETER AND THE BROKEN LANTERN CONTAINING THE RUBY COIL ALTOGETHER FROM THE PATIENT. IT WAS REPORTED THAT ACCESS TO THE TARGET VESSEL WAS LOST AND THE PHYSICIAN DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EF
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10440238 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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