LP Coil System RBYPCLP60-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00815948026209), received between Mar 23, 2024 and Jan 5, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (7 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.

• MalfunctionJan 5, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A PACKING COIL LP, A NON-PENUMBRA MICROCATHETER, NON-PENUMBRA BASE CATHETER, A SHORT SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE PACKING COIL LP IN THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO ADVANCE A SECOND PACKING COIL LP THROUGH THE MICROCATHETER. THE PACKING COIL LP WAS REMOVED AND THE MICROCATHETER WAS FLUSHED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SAME PACKING COIL LP THROUGH THE MICROCATHETER, BUT THE SAME ISSUE OCCURRED. WHILE REMOVING THE PACKING COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PACKING COIL LP HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED AND THE COIL WAS FLUSHED OUT FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA COIL 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 23968026 ↗
• 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 23341276 ↗
• MalfunctionDec 13, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN AORTIC ENDOLEAK USING PACKING COIL LPS AND A MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A PACKING COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN REALIZED THAT THE PACKING COIL LP HAD BECOME UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE PACKING COIL LP TO SUCCESSFULLY IMPLANT THE COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING A RUBY 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 20926604 ↗
• MalfunctionJun 10, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PACKING COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PACKING COIL LP UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE PHYSICIAN ASPIRATED THE DETACHED COIL WITH A SYRINGE. THE PROCEDURE WAS COMPLETED USING A NEW COIL 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 19506238 ↗
• MalfunctionMay 14, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL MAMMARY ARTERY (RIMA) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE PACKING COIL LPS IN THE TARGET LOCATION USING THE MICROCATHETER. NEXT, WHILE ADVANCING ANOTHER PACKING COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PACKING COIL LP WAS RETRACTED A COUPLE OF INCHES AND THEN WHILE READVANCING THE PACKING COIL LP, THE INTRODUCER SHEATH BROKE AND THE PACKING COIL LP UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING 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 19310301 ↗
• MalfunctionApr 8, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC DUCT USING A PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHEN ATTEMPTING TO RETRACT THE PACKING COIL LP BACK INTO THE MICROCATHETER, THE PACKING COIL LP HAD UNINTENTIONALLY DETACHED AND BECAME STUCK AT THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE HOSPITAL TECHNOLOGIST REMOVED THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP. THE COIL WAS THEN REMOVED OUT FROM THE MICROCATHETER, AND THE MICROCATHETER WAS FLUSHED. THE HOSPITAL TECHNOLOGIST REINSERTED THE SAME MICROCATHETER BACK INTO THE VESSEL. THE PROCEDURE WAS COMPLETED USING NEW 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 19068731 ↗
• MalfunctionMar 23, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE THYROCERVICAL, LEFT INTERNAL MAMMARY ARTERY (LIMA), AND VENOUS COLLATERAL USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A PACKING COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE MICROCATHETER WOULD KICK BACK OUT OF THE VESSEL. WHEN THE PHYSICIAN WENT TO RETRACT THE PACKING COIL LP, THERE WAS RESISTANCE NOTED AND THE COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP AND A NEW MICROCATHETER WAS PLACED IN THE VESSEL. NEXT, WHILE ADVANCING ANOTHER PACKING COIL LP INTO THE VESSEL, THE PHYSICIAN NOTICED THE PACKING COIL WAS TOO STIFF. THEREFORE, THE PACKING COIL LP WAS REMOVED AND SAVED FOR LATER TO BE USE IN A DIFFERENT VESSEL. WHEN THE PHYSICIAN ATTEMPTED TO REUSE THE PACKING COIL LP IN A DIFFERENT COLLATERAL VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL WOULD NOT ADVANCE OUT FROM ITS INTRODUCER SHEATH; THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PHYSICIAN THEN ADVANCED A THIRD PACKING COIL LP INTO THE VESSEL, BUT THE COIL WAS STIFF AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965627 ↗