LP Coil System RBYLP0204-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948025981), received between May 30, 2024 and Jul 18, 2025 — 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.

• MalfunctionJul 18, 2025Fracture; Premature Separation; Fracture; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A DISTAL GI ARTERY USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WAS ADVANCED INTO THE TARGET VESSEL WITH HALF OF THE COIL IN THE MICROCATHETER. THE EMBOLIZATION COIL THEN FRACTURED. IT WAS REPORTED THAT THE REMAINING SEGMENT OF RUBY COIL LP WAS IN THE MICROCATHETER WHEN THE EMBOLIZATION COIL FRACTURED. THE PHYSICIAN RETRACTED THE PUSHER ASSEMBLY WHEN THE REMAINDER OF THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY. THE PHYSICIAN THEN USED SALINE TO PUSH THE DETACHED EMBOLIZATION COIL FROM THE MICROCATHETER INTO THE TARGET VESSEL. 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 22546282 ↗
• MalfunctionMay 30, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING A RUBY COIL LP, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL LP THROUGH THE MICROCATHETER, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER, THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP WAS REMOVED FROM THE PATIENT AND THE MICROCATHETER WAS FLUSHED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19431964 ↗