Ruby XL Coil System RBYPODXL1055-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810169721742), received between Nov 10, 2025 and Jun 2, 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.

• MalfunctionJun 2, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN TWO VARICES OF THE LEFT RENAL VEIN USING A POD XL COIL (POD XL), A NON-PENUMBRA CATHETER (4FR), AND A NON-PENUMBRA SHEATH (7FR). THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE COILS IN THE FIRST VARIX. THE CATHETER WAS THEN REPOSITIONED TO THE SECOND VARIX AND PLACED ONE NON-PENUMBRA COIL. WHILE ADVANCING THE POD XL THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE CAUSING THE COIL'S PUSHER ASSEMBLY TO KINK. SUBSEQUENTLY, THE POD XL UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THE CATHETER WAS REMOVED; HOWEVER, THE EMBOLIZATION COIL REMAINED WITHIN THE SHEATH. THE SHEATH CONTAINING THE EMBOLIZATION COIL WAS REMOVED FROM THE PATIENT. ACCESS WAS LOST AND THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25367141 ↗
• MalfunctionNov 10, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VARICES USING A POD XL AND A NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED DIRECT STICK ACCESS IN THE ABDOMEN. THE POD XL WAS ADVANCED TO THE DISTAL END OF THE CATHETER, BUT WHILE ATTEMPTING TO ADVANCE THE POD XL IN THE VEIN, THE PHYSICIAN WAS EXPERIENCING RESISTANCE AND DECIDED TO REMOVE THE POD XL. THEN, WHILE REMOVING THE POD XL, THE COIL UNINTENTIONALLY DETACHED INSIDE THE CATHETER. THEREFORE, THE CATHETER CONTAINING THE DETACHED POD XL WAS REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED USING NEW POD XLS, PACKING COIL XLS, POD COILS, AND A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513535 ↗