Ruby XL Coil System RBYXL4070-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810169721650), received between Aug 12, 2025 and Mar 16, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC VEIN USING A RUBY XL AND A NON-PENUMBRA ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY XL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE RUBY XL HAD UNINTENTIONALLY DETACHED WITHIN THE ANGIOGRAPHIC CATHETER. THE PHYSICIAN REMOVED THE PUSHER ASSEMBLY AND THEN USED A GUIDEWIRE TO PUSH THE DETACHED RUBY XL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY XLS AND THE SAME ANGIOGRAPHIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603678 ↗
• MalfunctionSep 16, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK OF THE ABDOMINAL AORTIC ANEURYSM (AAA) GRAFT USING A RUBY XL, A NON-PENUMBRA CATHETER, AND A RADIO FREQUENCY GUIDEWIRE (RF GUIDEWIRE). DURING THE PROCEDURE, THE RF GUIDEWIRE WAS USED MULTIPLE TIMES PRIOR TO THE ADVANCEMENT OF THE RUBY XL. WHILE ADVANCING THE RUBY XL THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY XL BECAME STUCK. UPON ATTEMPTING TO RETRACT THE RUBY XL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THE CATHETER CONTAINING THE DETACHED RUBY XL WAS REMOVED. IT WAS REPORTED THAT THE CATHETER WAS DAMAGED WITH THE USAGE OF THE RF GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY XL, TWO PACKING COIL XLS, 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 23069395 ↗
• MalfunctionAug 12, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY VIA CONTRALATERAL APPROACH USING A RUBY XL, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY XL OUT OF THE DISTAL END OF THE CATHETER, THE RUBY XL WOULD NOT ADVANCE OUT OF THE CATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE THE RUBY XL OUT OF THE DISTAL END OF THE CATHETER A FEW TIMES WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO RETRACT THE RUBY XL. WHILE RETRACTING THE RUBY XL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THE CATHETER CONTAINING THE DETACHED RUBY XL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE CATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY XL COILS, THE SAME ANGIOGRAPHIC CATHETER, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22789748 ↗