Ruby XL Coil System RBYPODXL0410-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810169721667), received between Dec 5, 2025 and Apr 16, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A NON-PENUMBRA SHEATH (7F X 45CM), A NON-PENUMBRA CATHETER (4F X 135CM), AND A GLIDEWIRE. WHILE ADVANCING A POD XL THROUGH THE CATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER AFTER ADVANCING MORE THAN HALFWAY. THE DETACHED EMBOLIZATION COIL WAS PUSHED INTO THE TARGET LOCATION USING THE GLIDEWIRE. FIVE NON-PENUMBRA COILS WERE THEN PLACED INTO THE TARGET VESSEL. THE PHYSICIAN DECIDED TO USE A PACKING COIL XL. WHILE ADVANCING THE PACKING COIL XL THROUGH THE CATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER AFTER ADVANCING APPROXIMATELY HALFWAY. THE DETACHED EMBOLIZATION COIL WAS PUSHED OUT OF THE CATHETER USING THE GLIDEWIRE, PROXIMAL TO THE TARGET VESSEL. IT WAS REPORTED THAT THE CATHETER WAS FLUSHED BETWEEN COIL PLACEMENT. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894687 ↗
• MalfunctionDec 5, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FEEDER VESSEL OFF OF THE RUE FISTULA USING A PACKING COIL XL, POD XLS, AND A NON-PENUMBRA GLIDE CATHETER. DURING THE PROCEDURE, ONE POD XL WAS IMPLANTED INTO THE TARGET VESSEL. THE NEXT PACKING COIL XL PUSHER ASSEMBLY WAS NOTICED TO BE KINKED UPON REMOVAL OF THE PACKAGING. THE DAMAGE TO THE PACKING COIL XL WAS NOTICED PRIOR TO USE; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. ANOTHER POD XL WAS ADVANCED INTO THE GLIDE CATHETER. DIFFICULTY WAS EXPERIENCED WHEN TRACKING THE POD XL THROUGH THE CATHETER. IT WAS UNABLE TO BE ADVANCED THE LENGTH OF THE GLIDE CATHETER. THE PHYSICIAN RETRACTED THE POD XL, AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE GLIDE CATHETER. THE GLIDE CATHETER CONTAINING THE DETACHED POD XL WAS REMOVED. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735506 ↗