LP Coil System RBYPCLP45-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948026193), received between Mar 15, 2024 and May 19, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER (0.018). WHILE USING THE PACKING COIL LP, THE PACKING COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE EMBOLIZATION COIL INTO ITS TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ANOTHER PACKING 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 25224389 ↗
• MalfunctionOct 20, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP, A RUBY COIL LP, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE RUBY COIL LP IN THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO ADVANCE AND PACK THE NEXT PACKING COIL LP INTO THE VESSEL. WHILE REMOVING THE PACKING COIL LP, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN REINSERTED THE SAME MICROCATHETER INTO THE VESSEL. WHILE ATTEMPTING TO ADVANCE A NEW PACKING COIL LP, THE SAME ISSUE HAD OCCURRED. THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING NEW 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 23341256 ↗
• MalfunctionMar 15, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SIGMOID ARTERY OFF THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COIL LPS, PACKING COIL LP, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. TO TROUBLESHOOT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL USING A HEMOSTAT, BUT THE RUBY COIL LP STILL WOULD NOT DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE SAME ISSUE OCCURRED WITH THE NEXT RUBY COIL LP. THE PHYSICIAN THEN ADVANCED A PACKING COIL LP INTO THE TARGET LOCATION; HOWEVER, WHEN ATTEMPTING TO REPOSITION THE PACKING COIL LP, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN REINSERTED THE SAME MICROCATHETER BACK INTO THE VESSEL AND PLACED A RUBY COIL LP, BUT THE COIL WOULD NOT DETACH USING THE HANDLE. IT WAS ALSO REPORTED THAT THE SAME TROUBLESHOOTING ATTEMPTS WERE MADE TO DETACH THE RUBY COIL LP, BUT THE COIL STILL F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914509 ↗