RUBY Coil RBY2C0530-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00814548018645), received between Oct 10, 2018 and Aug 14, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA DIAGNOSTIC CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING RESISTANCE ADVANCING THE DISTAL END OF THE LANTERN THROUGH THE DIAGNOSTIC CATHETER. THE PHYSICIAN WAS THEN ADVANCING A RUBY COIL THROUGH THE LANTERN, BUT THE RUBY COIL BECAME STUCK AT THE DISTAL END OF THE LANTERN. WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE PHYSICIAN NOTICED THE LANTERN WAS KINKED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, NEW POD PACKING COILS (PACKING COIL), A NEW LANTERN, THE SAME DIAGNOSTIC CATHETER, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811791 ↗
• MalfunctionJan 13, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. IT WAS REPORTED THAT THE MICROCATHETER WAS THEN FLUSHED. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A NEW RUBY COIL THROUGH THE MID SHAFT OF THE MICROCATHETER AND DECIDED TO RETRACT THE RUBY COIL. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED 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 16161027 ↗
• MalfunctionOct 6, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE THE PHYSICIAN ATTEMPTED TO IMPLANT THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, A VASCULAR PLUG, A STENT, 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 15556277 ↗
• MalfunctionApr 15, 2022Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITH APPROXIMATELY TEN CENTIMETERS OF THE RUBY COIL IN THE TARGET VESSEL AND TWENTY CENTIMETERS OF THE RUBY COIL STILL IN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE SUPPORT WAS CHALLENGING DUE TO A SPASM IN THE GASTRODUODENAL ARTERY (GDA) WHICH WAS RELATED TO THE GI BLEED. 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 14118174 ↗
• MalfunctionSep 24, 2021Failure 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 ATTEMPTED TO ADVANCE A RUBY COIL OUT OF THE INTRODUCER SHEATH, BUT THERE WAS FRICTION. THE PHYSICIAN DECIDED NOT TO PUSH THE REST OF THE RUBY COIL AND REMOVED IT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524186 ↗
• MalfunctionNov 24, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS, A POD PACKING COIL (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FOUR COILS IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE POD PC THROUGH THE LANTERN, THE PUSHER ASSEMBLY OF THE POD COIL KINKED. THEREFORE, THE POD PC WAS REMOVED. NEXT, WHILE ADVANCING A RUBY COIL INTO THE LANTERN, THE RUBY COIL BECAME STUCK JUST PAST THE HUB OF THE LANTERN AND WOULD NOT ADVANCE FURTHER. SUBSEQUENTLY, THE PHYSICIAN RETRACTED AND ADVANCED THE RUBY COIL A FEW TIMES BUT WAS UNSUCCESSFUL; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN NOTED THAT THE LANTERN WAS FLUSHED BEFORE AND AFTER EVERY COIL PLACED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 10893241 ↗
• MalfunctionJun 30, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE THROUGH THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH NEW RUBY COILS 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 10212309 ↗
• MalfunctionJun 5, 2020Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN. SUBSEQUENTLY, THE RUBY COIL PREMATURELY DETACHED WITHIN THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 10122004 ↗
• MalfunctionMar 11, 2020Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING A RUBY COIL AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING THE RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN, THE PHYSICIAN WAS NOT SATISFIED WITH HOW THE COIL WAS FORMING. WHILE RETRACTING THE RUBY COIL TO RE-SHEATH IT, THE PROXIMAL END OF THE RUBY COIL ATTACHED TO THE PUSHER ASSEMBLY BECAME STRETCHED. IT WAS REPORTED THAT THE END OF THE RUBY COIL WAS UNWOUND AND WAS STICKING OUT OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN SUCCESSFULLY PULLED THE UNRAVELING WIRE OF THE RUBY COIL AND REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING A POD5 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 9821300 ↗
• MalfunctionJun 4, 2019Material Deformation; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A RUBY COIL, THE PUSHER WIRE OF THE RUBY COIL BECAME KINKED PRIOR TO INSERTION INTO THE MICROCATHETER. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8667670 ↗
• MalfunctionApr 12, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL GASTRIC ARTERY USING A RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE RUBY COIL INTO THE TARGET VESSEL AND REPORTED THAT THE RUBY COIL WAS ONLY ABLE TO ADVANCE 3/4TH OF THE WAY OUT OF THE NON-PENUMBRA MICROCATHETER. IT WAS ALSO REPORTED THAT RESISTANCE WAS ENCOUNTERED UPON RETRACTION OF THE RUBY COIL, WHILE ATTEMPTING TO REPOSITION THE RUBY COIL. THE RUBY COIL WAS THEN REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509581 ↗
• MalfunctionApr 5, 2019Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8486713 ↗
• MalfunctionMar 27, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING RUBY COILS. DURING PREPARATION FOR THE PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER FELT RESISTANCE WHILE ADVANCING THE RUBY COIL WITHIN THE LANTERN DELIVERY MICROCATHETER (LANTERN). CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL WAS KINKED. THEREFORE, THE RUBY COIL WAS REMOVED, AND THE PROCEDURE WAS CONTINUED 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 8456054 ↗
• MalfunctionMar 27, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING RUBY COILS. DURING PREPARATION FOR THE PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER FELT RESISTANCE WHILE ADVANCING THE RUBY COIL WITHIN THE LANTERN DELIVERY MICROCATHETER (LANTERN). CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL WAS KINKED. THEREFORE, THE RUBY COIL WAS REMOVED, AND THE PROCEDURE WAS CONTINUED USING A NEW RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8456044 ↗
• MalfunctionOct 10, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH THE TIP OF A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE RUBY COILS WERE REMOVED. 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 Consequences Or Impact To Patient

  MAUDE report 7954295 ↗