LP Coil System RBYPCLP10-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948026162), received between Aug 20, 2024 and Jun 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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.

• MalfunctionJun 12, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PACKING COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA TAPERED MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S VESSEL WAS TORTUOUS. A PACKING COIL LP WAS ADVANCED THROUGH THE MICROCATHETER INTO THE TARGET VESSEL; HOWEVER, THE PACKING COIL LP FAILED TO DETACH USING THE HANDLE. THE PHYSICIAN DECIDED TO REMOVE AND RESHEATH THE PACKING COIL LP. WHILE ATTEMPTING TO REMOVE THE PACKING COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PACKING COIL LP PUSHER ASSEMBLY WAS THEN USED TO PUSH THE EMBOLIZATION COIL INTO THE TARGET LOCATION. THE SAME ISSUE OCCURRED WITH TWO ADDITIONAL PACKING COIL LPS. BOTH EMBOLIZATION COILS WERE ALSO PUSHED INTO THE TARGET LOCATION USING THEIR PUSHER ASSEMBLIES. THE PROCEDURE WAS COMPLETED USING SEVEN NON-PENUMBRA DETACHABLE 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 25487076 ↗
• MalfunctionAug 20, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING A PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PACKING COIL LPS IN THE TARGET VESSEL. IT WAS NOTED THAT THE CATHETER WAS FLUSHED WITH SALINE BETWEEN EACH COIL. WHILE ADVANCING THE NEXT PACKING COIL LP, THE PHYSICIAN ENCOUNTERED RESISTANCE. SUBSEQUENTLY, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP. THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 20007848 ↗