RUBY Coil RBY2C3660-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00814548019420), received between Jan 17, 2019 and Jun 12, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 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 10 most recent of 10 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 RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. THE PHYSICIAN SUCCESSFULLY PLACED THREE RUBY COILS IN THE TARGET LOCATION USING THE MICROCATHETER. AFTER ADVANCING ANOTHER RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN REPORTED THAT THE COIL WAS NOT TAKING ITS INTENDED SHAPE. WHILE REPEATEDLY ADVANCING AND RETRACTING THE RUBY COIL, THE COIL UNINTENTIONALLY DETACHED. THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT, AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A TOTAL OF FIFTEEN RUBY COILS AND POD 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 25490131 ↗
• MalfunctionApr 22, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING RUBY COILS AND A MICROCATHETER. THE PHYSICIAN WAS ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER AND REPORTED THAT THE COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE VESSEL AND PARTIALLY WITHIN THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY 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 24960939 ↗
• MalfunctionDec 1, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CORONARY ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RUBY COILS IN THE TARGET LOCATION USING THE LANTERN. WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE MID-SHAFT OF THE LANTERN. WHILE ATTEMPTING TO RETRACT AND RE-ADVANCE THE RUBY COIL WITHIN THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT, AND THE RUBY COIL WAS THEN FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687814 ↗
• MalfunctionAug 21, 2024Fracture; Physical Resistance/Sticking; Premature Separation; Fracture; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE OF THE SPLENIC ANEURYSM USING POD PACKING COILS (PACKING COIL), RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), VASCULAR PLUG, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED A VASCULAR PLUG DISTAL TO THE ANEURYSM USING THE 6FR SHEATH. NEXT, A LANTERN WAS ADVANCED INTO THE LOCATION OF THE VASCULAR PLUG. THE PHYSICIAN ATTEMPTED TO ADVANCE A PACKING COIL THROUGH THE LANTERN BUT KINKED THE COIL; THEREFORE, THE PACKING COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED AND DETACHED TWO NEW PACKING COILS BEHIND THE VASCULAR PLUG. NEXT, THE PHYSICIAN RETRACTED THE LANTERN BACK INTO THE ANEURYSM AND PLACED FIVE RUBY COILS IN THE ANEURYSM. WHILE ATTEMPTING TO ADVANCE THE SIXTH RUBY COIL, THE COIL KINKED AND WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL, BUT EXPERIENCED RESISTANCE AND THE RUBY COIL PUSHER ASSEMBLY WAS KINKED AND FRACTURED; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN TRIED TO ADVANCE TWO NEW RUBY COILS THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS NOTED. THEREFORE, BOTH RUBY COILS AND THE LANTERN WERE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN WAS SATISFIED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20012549 ↗
• MalfunctionMay 24, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT AND LEFT LUMBAR VESSELS USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDE WIRE. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE COIL WOULD NOT ADVANCE OUT OF THE LANTERN AND INTO THE TARGET VESSEL. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO ADVANCE AND RETRACT THE RUBY COIL THROUGH THE LANTERN, BUT IT WAS NOTED THAT ONLY A SMALL PORTION OF THE RUBY COIL WOULD ADVANCE OUT THE DISTAL END OF THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN WAS RETRACTING THE RUBY COIL SLOWLY BACK INTO THE LANTERN WHEN THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392370 ↗
• MalfunctionDec 13, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC VEIN USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL. HOWEVER, UPON RETRACTION, IT WAS NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING FIVE RUBY COILS, NON-PENUMBRA 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 12982161 ↗
• MalfunctionOct 17, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A VARIX IN THE PORTAL SYSTEM USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE INSERTING A RUBY COIL INTO THE MICROCATHETER, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY 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 12643939 ↗
• MalfunctionOct 8, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTA USING RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL INTO THE LANTERN, THE RUBY COIL INADVERTENTLY KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, AND THE SAME LANTERN. 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 10651131 ↗
• MalfunctionDec 20, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED RUBY COILS IN THE TARGET VESSEL USING A LANTERN. AFTER PLACING A NEW RUBY COIL IN THE VESSEL, THE PHYSICIAN WAS NOT SATISFIED WITH THE COIL POSITION AND DECIDED TO RETRACT AND RE-SHEATH IT. WHILE ATTEMPTING TO PLACE THE SAME RUBY COIL, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE ADVANCING THE COIL THROUGH THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508025 ↗
• MalfunctionJan 17, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL OUT OF THE TIP OF THE LANTERN AND; THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE HOSPITAL STAFF THEN NOTICED THAT THE LANTERN WAS KINKED 1 CM FROM THE DISTAL TIP. THE RUBY COIL WAS ACCIDENTALLY THROWN AWAY AND; THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256465 ↗