LP Coil System RBYPCLP15-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948026179), received between Nov 23, 2024 and Dec 11, 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.

• MalfunctionDec 11, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR AN ARTERIOVENOUS MALFORMATION (AVM) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVERAL PACKING COIL LPS IN THE TARGET LOCATION. AN ADDITIONAL PACKING COIL LP WAS ADVANCED TO THE TARGET LOCATION. THE PHYSICIAN DECIDED TO REPOSITION THE PACKING COIL LP IN THE TARGET LOCATION. WHILE RETRACTING THE PACKING COIL LP, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE EMBOLIZATION COIL WAS REMOVED FROM THE PATIENT, AND THE PACKING COIL LP WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH MORE PACKING 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 23776784 ↗
• MalfunctionNov 3, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PACKING COIL LP. DURING THE PROCEDURE, IT WAS REPORTED THAT THE COIL HAD UNINTENTIONALLY DETACHED. THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE PACKING COIL LP. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458359 ↗
• MalfunctionDec 13, 2024Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE PACKING COIL LP INTO THE TARGET LOCATION. THE PHYSICIAN THEN ADVANCED ANOTHER PACKING COIL LP INTO THE TARGET LOCATION. WHILE RETRACTING THE PACKING COIL LP FOR REPOSITIONING, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE PACKING COIL LP AND THE COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE PACKING COIL LP TO SUCCESSFULLY PUSH THE REMAINING FIVE CENTIMETERS OF THE COIL OUT OF MICROCATHETER, AND INTO THE TARGET LOCATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THIS POINT AND NO ADDITIONAL COILS WERE NECESSARY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926781 ↗
• MalfunctionNov 23, 2024Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP, RUBY COIL LPS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE RUBY COIL LPS IN THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER PACKING COIL LP IN THE VESSEL. WHILE POWER INJECTING CONTRAST, THE LAST PACKING COIL LP PLACED WAS PUSHED FROM THE GDA TO THE RIGHT HEPATIC ARTERY. IT WAS REPORTED THAT THE PHYSICIAN DID NOT HAVE A SMALL ENOUGH SNARE DEVICE TO BE USED TO REMOVE THE PACKING COIL LP DUE TO THE TORTUOSITY AND DIAMETER OF THE VESSEL. THEREFORE, THE PACKING COIL LP WAS LEFT IN THE RIGHT HEPATIC ARTERY. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20766097 ↗