RUBY Coil RBY2C0520-BRecalls & reported problems
Penumbra, Inc. · Ruby Standard, 5x20 · Class 2
All models of RUBY Coil (90)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548018638), received between Nov 23, 2018 and Jun 26, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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
- Device Damaged Prior to Use1
- Failure to Advance1
- Material Deformation1
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN AN ACCESSORY RENAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TWO PENUMBRA COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT RUBY COIL INTO THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE MORE THAN FIVE CENTIMETERS INTO THE HUB OF THE LANTERN; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL 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 10198899 ↗MalfunctionNov 23, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation
DURING PREPARATION FOR A MEDICAL PROCEDURE, A HOSPITAL STAFF FOUND THAT THE PUSHER WIRE OF A RUBY COIL WAS BENT PRIOR TO REMOVING THE COIL FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.
Patient problems: No Patient Involvement
MAUDE report 8099959 ↗
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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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