LP Coil System RBYLP0430-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948026056), received between Aug 9, 2024 and Apr 22, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A HEPATIC BLEED USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE COIL IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET VESSEL BUT DID NOT LIKE THE WAY THE COIL WAS POSITIONED. THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL LP. WHILE RETRACTING, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE VESSEL. IT WAS REPORTED THAT THE PHYSICIAN USED THE COIL'S PUSHER WIRE TO PUSH THE RUBY COIL LP INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886571 ↗
• MalfunctionMar 21, 2025Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL MAMMARY VESSEL USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A 3MM X 15CM RUBY COIL LP INTO THE TARGET VESSEL. HOWEVER, THE RUBY COIL LP WOULD NOT TAKE ITS INTENDED SHAPE. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN ADVANCED A SECOND RUBY COIL LP (2MM X 10 CM) TO THE TARGET VESSEL. HOWEVER, THE SAME ISSUE WAS EXPERIENCED. THEREFORE, THE SECOND RUBY COIL LP WAS REMOVED. THE PHYSICIAN PLACED A NEW RUBY COIL LP (4MM X 30CM) IN THE TARGET VESSEL. WHILE OPENING ANOTHER COIL, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE RUBY COIL LP HAD MIGRATED DISTALLY FROM ONE OF THE BRANCHES OF THE BIFURCATION. THE PHYSICIAN INDICATED THE RUBY COIL LP WAS IN A SAFE LOCATION. A GEL FOAM WAS USED TO FILL THE REMAINING SPACE IN THE TARGET SITE COVERING THE RUBY COIL LP. 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 21663461 ↗
• MalfunctionDec 13, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE FIRST RUBY COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN KINKED THE COIL, AND THE RUBY COIL LP HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED CONTAINING THE DETACHED RUBY COIL LP AND THE COIL WAS FLUSHED OUT. THE MICROCATHETER WAS THEN READVANCED BACK INTO THE TARGET LOCATION. NEXT, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SECOND RUBY COIL LP THROUGH THE MICROCATHETER AND THE COIL WAS REMOVED. A THIRD RUBY COIL LP WAS ADVANCED INTO THE VESSEL AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING A HANDLE, BUT THE RUBY COIL LP WOULD NOT DETACH. THEN, WHILE REMOVING THE RUBY COIL LP, THE COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL LP. IT WAS ALSO REPORTED THAT THE PHYSICIAN DECIDED TO REMOVE AND SWITCH TO A LARGER SIZE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A POD COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926199 ↗
• MalfunctionAug 9, 2024Premature Separation; 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. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL LP THROUGH THE MICROCATHETER, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL 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 19955212 ↗