LP Coil System RBYLP0202-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948025974), received between Apr 19, 2024 and Jan 20, 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 18, 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.

• MalfunctionJan 20, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLIC ARTERY USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE RUBY COIL LP WAS RESHEATHED. THE PHYSICIAN ATTEMPTED TO READVANCE THE RUBY COIL LP; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN. THE PHYSICIAN REMOVED THE RUBY COIL LP. AFTER REMOVAL, THE PHYSICIAN FOUND THE RUBY COIL LP DETACHED INSIDE MICROCATHETER. THE PHYSICIAN USED A SYRINGE TO ASPIRATE THE RUBY COIL LP TO THE PROXIMAL PORTION OF THE MICROCATHETER. A GUIDEWIRE AND HEMOSTATS WERE USED TO REMOVE THE DETACHED RUBY COIL LP FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL RUBY COIL LPS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114384 ↗
• MalfunctionMay 16, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL BRANCH OF THE RIGHT PROFUNDA USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL LP THROUGH THE MICROCATHETER, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP WAS REMOVED. AFTER REMOVING THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP, IT WAS REPORTED THAT THE DETACHED RUBY COIL LP COULD NOT BE REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING MICROSPHERES, GEL FOAM, AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040359 ↗
• MalfunctionApr 19, 2024Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE RUBY COIL LP INTO THE MICROCATHETER. AFTER THE RUBY COIL LP WOULD NOT ADVANCE FURTHER INTO THE MICROCATHETER, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. WHILE RETRACTING THE RUBY COIL LP, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL LP AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149215 ↗