LP Coil System RBYLP0105-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00815948025967), received between Apr 23, 2025 and Jun 2, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HEPATIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE TREATMENT SITE WAS VERY TORTUOUS. WHILE ADVANCING A RUBY COIL LP MID-WAY THROUGH THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. UPON PUSHING THROUGH THE RESISTANCE, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL FROM THE PATIENT. THE PHYSICIAN WAS UNABLE TO RE-GAIN ACCESS TO TARGET LOCATION. THE PROCEDURE WAS COMPLETED WITH GEL FOAM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25367524 ↗
• MalfunctionApr 11, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILEOCOLIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING ADVANCEMENT OF A RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN NOTED RESISTANCE DESCRIBED AS A GRITTY FEEL, AND THE COIL DID NOT FULLY ADVANCE BEYOND THE DISTAL END OF THE MICROCATHETER. DURING RETRACTION, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH A SECOND RUBY COIL LP. THE MICROCATHETER CONTAINING THE SECOND DETACHED EMBOLIZATION COIL WAS ALSO REMOVED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NEW RUBY COIL LP AND THE SAME MICROCATHETER. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849037 ↗
• MalfunctionApr 2, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A RUBY COIL LP THROUGH THE MICROCATHETER, THE RUBY COIL LP HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP AND THE EMBOLIZATION COIL WAS FLUSHED OUT FROM THE MICROCATHETER USING SALINE. THE MICROCATHETER WAS ADVANCED BACK INTO THE VESSEL. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL LP AND THE SAME ISSUE OCCURRED. THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP WAS REMOVED AND THE EMBOLIZATION COIL WAS FLUSHED OUT. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO SWITCH TO A NEW MICROCATHETER. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS AND THE NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769578 ↗
• MalfunctionApr 2, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A RUBY COIL LP THROUGH THE MICROCATHETER, THE RUBY COIL LP HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP AND THE EMBOLIZATION COIL WAS FLUSHED OUT FROM THE MICROCATHETER USING SALINE. THE MICROCATHETER WAS ADVANCED BACK INTO THE VESSEL. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL LP AND THE SAME ISSUE OCCURRED. THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP WAS REMOVED AND THE EMBOLIZATION COIL WAS FLUSHED OUT. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO SWITCH TO A NEW MICROCATHETER. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS AND THE NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769562 ↗
• MalfunctionMar 9, 2026Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR TIBIAL ARTERY (PTA) USING A RUBY COIL LP, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED AND DETACHED TWO RUBY COIL LPS INTO THE TARGET LOCATION USING THE HANDLE. WHILE MAKING MULTIPLE ATTEMPTS TO DETACH ANOTHER RUBY COIL LP INTO THE TARGET LOCATION USING THE SAME HANDLE, THE RUBY COIL LP WOULD NOT DETACH. THE PHYSICIAN DID NOT ATTEMPT TO MANUALLY DETACH THE RUBY COIL LP. WHILE RETRACTING THE RUBY COIL LP, THE EMBOLIZATION COIL DETACHED WITHIN THE LANTERN. THE LANTERN CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL LP, THE SAME HANDLE, AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545130 ↗
• MalfunctionMay 5, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE MICROCATHETER AND REPORTED THAT THE COIL BECAME STUCK NEAR THE DISTAL END AND UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP WAS REMOVED FROM THE PATIENT, AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS 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 21963978 ↗
• MalfunctionApr 23, 2025Physical Resistance/Sticking; Premature Separation; 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. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL LP UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED COIL 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 21895936 ↗