RUBY Coil RBY2C0312-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00814548018553), received between Oct 15, 2018 and May 23, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD PACKING COIL (PACKING COIL), A RUBY COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COIL, WHICH WAS SUBSEQUENTLY FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080923 ↗
• MalfunctionNov 26, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED, AND THE RUBY COIL WAS FLUSHED OUT OF THE MICROCATHETER. 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 20780445 ↗
• MalfunctionMar 21, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OBTUSE MARGINAL ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL OUT FROM THE INTRODUCER SHEATH, THE PHYSICIAN KINKED THE RUBY COIL; THEREFORE, IT WAS REMOVED. NEXT, WHILE ADVANCING AND RETRACTING A NEW RUBY COIL INTO THE TARGET LOCATION TO FORM THE COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS ADVANCING A THIRD RUBY COIL TO THE END OF THE MICROCATHETER; HOWEVER, IT WAS REPORTED THE PHYSICIAN THEN PULLED BACK ON THE RUBY COIL AND NOTICED THE COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER BACK INTO THE VESSEL. THE PROCEDURE WAS COMPLETED USING NEW RUBY 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 16588464 ↗
• MalfunctionFeb 9, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN. IT WAS REPORTED THAT THE LANTERN WAS NOT POSITIONED WELL. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED 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

  MAUDE report 16335735 ↗
• MalfunctionJun 10, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE RUBY COIL WOULD NOT DEPLOY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979466 ↗
• MalfunctionJun 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT FOURTH LUMBAR ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THE LUMBAR ARTERY WAS VERY TORTUOUS, MAKING WHAT APPEARED TO BE CLOSE TO 90 DEGREES BEND BEFORE THE INTENDED LANDING ZONE. DURING THE PROCEDURE, A RUBY COIL (F103384) WOULD NOT FULLY EXIT THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE NEXT RUBY COIL (F101241) WOULD ONLY PARTIALLY EXIT THE MICROCATHETER, AND THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF A NON-PENUMBRA COIL TO PUSH THE COIL WHERE THE PHYSICIAN WANTED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966108 ↗
• MalfunctionDec 12, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GENICULATE ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF THE RUBY COIL WAS FOUND TO BE SLIGHTLY BENT UPON REMOVAL FROM THE DISPENSER HOOP. SUBSEQUENTLY, WHILE ADVANCING THE RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL BENT IN HALF; 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 10995157 ↗
• MalfunctionDec 5, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS, RUBY COIL AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN DECIDED NOT TO USE THE LANTERN AND EXCHANGE IT FOR ANOTHER NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A RUBY COIL INTO THE MICROCATHETER; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE PAST THE ROTATING HEMOSTASIS VALVE (RHV) AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND ANOTHER COIL. 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 10954289 ↗
• MalfunctionJul 17, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VESSEL OFF THE SPLENIC ARTERY USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND SAFELY FLUSHED OUT THE COIL ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS 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 10290854 ↗
• MalfunctionFeb 27, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL INTO THE MICROCATHETER, THE PUSHER WIRE BECAME KINKED; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767080 ↗
• MalfunctionSep 5, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE OUT OF THE MICROCATHETER AND, 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 Consequences Or Impact To Patient

  MAUDE report 8967288 ↗
• MalfunctionApr 17, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE DISTAL END OF THE NON-PENUMBRA MICROCATHETER. THE RUBY COIL WAS UNABLE TO ADVANCE BEYOND THE POINT OF RESISTANCE IN THE MICROCATHETER, THEREFORE; THE RUBY COIL AND THE MICROCATHETER WERE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8523957 ↗
• MalfunctionOct 15, 2018Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A RUBY COIL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), HOWEVER, THE RUBY COIL WAS NOT TAKING ITS INTENDED SHAPE AND WAS PUSHING THE LANTERN OUT OF THE TARGET LOCATION. THE RUBY COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7967656 ↗