LP Coil System RBYLP0530Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948021846), received between Mar 17, 2020 and Dec 2, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed 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 16, 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 2, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ENDOLEAK USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER AND CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER AND USED A HANDLE TO DETACH IT; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP AND HANDLE WERE REMOVED. THE PHYSICIAN THEN ENCOUNTERED THE SAME ISSUE WITH THE NEXT RUBY COIL LP AND HANDLE; THEREFORE, THE RUBY COIL LP AND HANDLE WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER AND CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10933614 ↗
• MalfunctionMar 31, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTIC USING PACKING COIL LPS, RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE HANDLE. HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL, AND IT WAS OBSERVED THAT THE BLACK ALIGNMENT ZONE ON THE HANDLE HAD MINIMAL SEPARATION; SUBSEQUENTLY, THE PHYSICIAN USED THEIR FINGERS TO PIN AND PULL THE PUSHER ASSEMBLY OF THE PACKING COIL LP TO MANUALLY DETACH IT. IN THE MIDDLE OF THE PROCEDURE, A RUBY COIL LP (F94634) WAS FOUND KINKED UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL LP WAS FOUND PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN CONTINUED THE PROCEDURE, AND THE ISSUE WITH THE PACKING COIL LP OCCURRED WITH THREE ADDITIONAL PACKING COIL LPS AND TWO RUBY COILS LPS. ANOTHER HANDLE WAS OPENED AND USED WITH ATTEMPTS TO DETACH THE COILS, BUT IT IS UNKNOWN AT WHICH POINT THE SECOND HANDLE WAS USED; THEREFORE, THE COILS WERE ALSO MANUALLY DETACHED USING THE PIN AND PULL TECHNIQUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908831 ↗
• MalfunctionMar 31, 2020Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTIC USING PACKING COIL LPS, RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE HANDLE. HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL, AND IT WAS OBSERVED THAT THE BLACK ALIGNMENT ZONE ON THE HANDLE HAD MINIMAL SEPARATION; SUBSEQUENTLY, THE PHYSICIAN USED THEIR FINGERS TO PIN AND PULL THE PUSHER ASSEMBLY OF THE PACKING COIL LP TO MANUALLY DETACH IT. IN THE MIDDLE OF THE PROCEDURE, A RUBY COIL LP (F94634) WAS FOUND KINKED UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL LP WAS FOUND PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN CONTINUED THE PROCEDURE, AND THE ISSUE WITH THE PACKING COIL LP OCCURRED WITH THREE ADDITIONAL PACKING COIL LPS AND TWO RUBY COILS LPS. ANOTHER HANDLE WAS OPENED AND USED WITH ATTEMPTS TO DETACH THE COILS, BUT IT IS UNKNOWN AT WHICH POINT THE SECOND HANDLE WAS USED; THEREFORE, THE COILS WERE ALSO MANUALLY DETACHED USING THE PIN AND PULL TECHNIQUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908830 ↗
• MalfunctionMar 17, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LP, POD PACKING COIL LP, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS STUCK AND WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE RUBY COIL LP WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE THE SAME RUBY COIL LP ON THE BACK TABLE, BUT THE COIL WOULD NOT ADVANCE WITHIN THE INTRODUCER SHEATH. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A POD PACKING COIL LP INTO THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED, AND THE COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE POD PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844656 ↗