LP Coil System RBYLP0210-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815948025998), received between Mar 8, 2024 and Dec 18, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GI BLEED USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL LP INTO THE MICROCATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW 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 23845701 ↗
• MalfunctionDec 11, 2025Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THERE WAS HIGH BLOOD FLOW. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE RUBY COIL LP INTO ITS TARGET LOCATION. THE HOSPITAL STAFF OBSERVED THE RUBY COIL LP WAS NOT FULLY ANCHORED AND THE RUBY COIL TAIL END WAS PROTRUDING INTO THE PARENT VESSEL. A SNARE DEVICE WAS USED TO SUCCESSFULLY REMOVE THE RUBY COIL LP. 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 23776811 ↗
• MalfunctionDec 2, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GI BLEED USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A 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 AND THE EMBOLIZATION COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED WITH A NEW 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 23699968 ↗
• 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 20926182 ↗
• MalfunctionMar 8, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER ADVANCING THE RUBY COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT THE COIL TO REPOSITION THE MICROCATHETER. HOWEVER, WHILE RETRACTING THE RUBY COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL LP UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866785 ↗