Ruby XL Coil System RBYPODXL0870-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810169721735), received between Jul 29, 2025 and Feb 11, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionFeb 11, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING A POD XL AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE POD XL THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE POD XL UNINTENTIONALLY DETACHED INSIDE THE CATHETER. THEREFORE, THE CATHETER CONTAINING THE DETACHED POD XL WAS REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED USING A NEW POD XL AND A NEW NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318498 ↗
• MalfunctionJul 29, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD XL AND A NON-PENUMBRA DIAGNOSTIC CATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD XL THROUGH THE DIAGNOSTIC CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN CONTINUED ADVANCING THE POD XL AGAINST RESISTANCE AND THE POD XL BECAME STUCK. WHILE RETRACTING THE POD XL WITH FORCE, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE DISTAL LENGTH OF DIAGNOSTIC CATHETER. THE POD XL PUSHER ASSEMBLY WAS REMOVED. THE PHYSICIAN THEN REMOVED THE DIAGNOSTIC CATHETER CONTAINING THE DETACHED EMBOLIZATION COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW DIAGNOSTIC CATHETER AND A POD COIL AND PACKING COIL XL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22654583 ↗