Ruby XL Coil System RBYPODXL1655-ARecalls & reported problems
Penumbra, Inc. · POD XL, 16mm 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 00810169721773), received between Nov 21, 2025 and Nov 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
- 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.
MalfunctionNov 21, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING POD XLS AND A NON-PENUMBRA GLIDE CATHETER. IT WAS REPORTED THAT THE POD XL APPEARED TO HAVE NO DAMAGE UPON REMOVAL FROM THE PACKAGING. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE POD XL INTO THE TARGET VESSEL. WHILE ADVANCING THE NEXT POD XL, THROUGH THE GLIDE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE GLIDE CATHETER. THE GLIDE CATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. THE GLIDE CATHETER WAS READVANCED INTO THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY ADVANCING THE NEXT POD XL THROUGH THE GLIDE CATHETER. THE GLIDE CATHETER WAS REMOVED, AND A NON-PENUMBRA CATHETER WAS USED. THE SAME POD XL WAS READVANCED AND SUCCESSFULLY PLACED INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER POD XL AND THE SAME NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23623375 ↗
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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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