LP Coil System RBYLP0415-BRecalls & reported problems
Penumbra, Inc. · Ruby Coil LP, 4 mm x 15 cm · Class 2 · Implant
All models of LP Coil System (38)
Data updated Oct 18, 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 00815948026049), received between Apr 12, 2024 and Apr 12, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2024Premature Separation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE RUBY COIL LP IN THE TARGET VESSEL, THE RUBY COIL LP HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE RUBY COIL LP WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE SAME ISSUE THEN OCCURRED WITH THE NEXT RUBY COIL LP AND THE COIL WAS REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19098892 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
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- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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