LP Coil System RBYLP0315-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948026025), received between Aug 21, 2024 and Sep 13, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionSep 13, 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, A NON-PENUMBRA SHEATH, A NON-PENUMBRA BASE CATHETER, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO RUBY COIL LPS INTO THE TARGET LOCATION. IT WAS REPORTED THAT THE MICROCATHETER WAS FLUSHED BETWEEN EACH COIL PLACEMENT. WHILE ADVANCING A THIRD RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE NEAR THE PROXIMAL END OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL LP. WHILE RETRACTING THE RUBY COIL LP, THE RUBY COIL LP HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER AT THE PROXIMAL END NEAR THE HUB. THE MICROCATHETER CONTAINING THE RUBY COIL LP WAS REMOVED. THE HOSPITAL STAFF THEN CUT THE MICROCATHETER AND PULLED THE RUBY COIL LP USING A HEMOSTAT. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL RUBY COIL LPS, THE SAME SHEATH, THE SAME BASE CATHETER, ANOTHER MICROCATHETER, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217708 ↗
• MalfunctionAug 21, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PELVIC BLEED USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN MET RESISTANCE AND THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP. IT WAS REPORTED THAT THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING 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 20018829 ↗