Ruby XL Coil System RBYXL2455-ARecalls & reported problems
Penumbra, Inc. · Ruby Coil XL, 24mm x 55cm · Class 2 · Implant
All models of Ruby XL Coil System (14)
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 00810169721612), received between Sep 22, 2026 and Sep 22, 2026 — 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.
MalfunctionSep 22, 2026Premature Separation
The patient was undergoing a coil embolization procedure in the gastric varices using a Packing Coil XL, Ruby XL, and a non-Penumbra diagnostic catheter. While advancing a Packing Coil XL to the target location, the physician encountered resistance. Upon retraction, the embolization coil unintentionally detached within the diagnostic catheter. The physician subsequently used saline to flush the detached Packing Coil XL into the vessel.While advancing the a Ruby XL, resistance was encountered again. The Ruby XL was retracted and it unintentionally detached within the diagnostic catheter. The physician subsequently used saline to flush the detached Ruby XL into the vessel.The procedure was completed using a new non-Penumbra coil and the same diagnostic catheter. There was no report of an adverse effect to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852406 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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