LP Coil System RBYLP0860-BRecalls & reported problems
Penumbra, Inc. · Ruby Coil LP, 8 mm x 60 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948026117), received between Mar 13, 2024 and Mar 13, 2024 — classified as 1 injury.
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
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2024Premature Separation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PUSHER WIRE OF THE RUBY COIL LP WAS SLIGHTLY KINKED. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL LP THROUGH THE MICROCATHETER, THE RUBY COIL LP UNINTENTIONALLY DETACHED IN THE PATIENT'S VESSEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE RUBY COIL LP. THE PROCEDURE WAS COMPLETED USING A NEW COIL (UNKNOWN) AND THE SAME MICROCATHETER.
Patient problems: Foreign Body In Patient
MAUDE report 18899244 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- 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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