LP Coil System RBYLP0740Recalls & reported problems
Penumbra, Inc. · Ruby Coil LP, 7 mm x 40 cm · Class 2 · Implant
All models of LP Coil System (38)
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 00815948021877), received between May 7, 2021 and Dec 5, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
- Material Deformation1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2021Material Deformation; Material Deformation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING A PACKING COIL LP, RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE PACKING COIL LP INTO THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST HAND WAS HOLDING THE COIL AT THE STARTING POSITION OF THE INTRODUCER SHEATH AND, CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE PACKING COIL LP BECAME BENT. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE HOSPITAL TECHNOLOGIST THEN ATTEMPTED TO ADVANCE TWO RUBY COIL LPS INTO THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL LP COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12931061 ↗MalfunctionMay 7, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE PORTAL VEIN USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WAS STUCK IN THE FRICTION LOCK. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11794639 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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