RUBY Coil RBY2C0320-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00814548018560), received between Nov 21, 2019 and Jun 6, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK IN THE ILIOLUMBAR ARTERY USING A RUBY COIL, AN EMBOLIC GLUE, AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THE EMBOLIC GLUE AND ATTEMPTED TO TRAP THE GLUE USING A RUBY COIL. WHILE ADVANCING THE RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN DID NOT LIKE THE WAY THE RUBY COIL WAS PACKING ATTEMPTED TO RETRACT IT OUT OF THE GLUE FOR REPOSITIONING; HOWEVER, RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THAT THE RUBY COIL WOULD NOT RETRACT COMPLETELY INTO THE MICROCATHETER. WHILE ATTEMPTING TO REMOVE THE RUBY COIL USING A SNARE DEVICE, THE COIL FRACTURED AT THE DISTAL END AND ONLY PART OF THE RUBY COIL WAS REMOVED FROM THE PATIENT. THE REMAINING PART OF THE RUBY COIL WAS LEFT IN THE TARGET VESSEL. 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 17075926 ↗
• MalfunctionDec 30, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE 2 ENDOLEAK USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL AND THE COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16080839 ↗
• MalfunctionOct 19, 2022Premature Separation; 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 PHYSICIAN WAS ADVANCING AND REPOSITIONING THE RUBY COIL IN THE TARGET LOCATION WHEN THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. SUBSEQUENTLY, THE PHYSICIAN REINSERTED THE LANTERN AND ATTEMPTED TO ADVANCE A NEW RUBY COIL INTO THE VESSEL. HOWEVER, THE SAME ISSUE HAD OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING TWO POD PACKING COILS (POD PC), 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 15635836 ↗
• MalfunctionOct 19, 2022Premature Separation; 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 PHYSICIAN WAS ADVANCING AND REPOSITIONING THE RUBY COIL IN THE TARGET LOCATION WHEN THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. SUBSEQUENTLY, THE PHYSICIAN REINSERTED THE LANTERN AND ATTEMPTED TO ADVANCE A NEW RUBY COIL INTO THE VESSEL. HOWEVER, THE SAME ISSUE HAD OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING TWO POD PACKING COILS (POD PC), 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 15635778 ↗
• MalfunctionMay 12, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A RUBY COIL, AND A CATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING THE ADVANCE THE RUBY COIL INTO THE CATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE CATHETER. IT IS UNKNOWN IF A MICROCATHETER WAS USED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14375161 ↗
• MalfunctionApr 13, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106227 ↗
• MalfunctionMar 14, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX RUBY COILS USING THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. AFTERWARD, THE PHYSICIAN RETRACTED THE RUBY COIL IN AN ATTEMPT TO SHAPE THE RUBY COIL TIGHTER; HOWEVER, WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED WITH PART OF THE RUBY COIL IN THE TARGET VESSEL AND THE OTHER PART IN THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO FLUSH THE RUBY COIL INTO THE TARGET VESSEL USING SALINE; HOWEVER, IT WAS UNSUCCESSFUL AND THE MICROCATHETER CAME OUT OF THE TARGET VESSEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. THE PROCEDURE WAS 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 13759242 ↗
• MalfunctionJan 26, 2022Detachment of Device or Device Component

  COILS DETACHED ON THEIR OWN. NO HARM/INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13357734 ↗
• MalfunctionOct 13, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL WAS ABLE TO ADVANCE PAST ITS INITIAL POSITION; HOWEVER, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED WHILE ADVANCING THE RUBY COIL THROUGH ITS INTRODUCER SHEATH. THEREFORE, THE PHYSICIAN STOPPED ADVANCING THE RUBY COIL AND IT 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 12627526 ↗
• MalfunctionSep 24, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS, A NON-PENUMBRA PARENT CATHETER AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED NINE COILS IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN ACCIDENTALLY PULLED THE LANTERN INTO THE PARENT CATHETER. CONSEQUENTLY THE RUBY COIL TOOK SHAPE WITHIN THE PARENT CATHETER AND SUBSEQUENTLY THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PARENT CATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. 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 Consequences Or Impact To Patient

  MAUDE report 10584087 ↗
• MalfunctionAug 5, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE INTRODUCING THE RUBY COIL TO THE LANTERN, THE PUSHER ASSEMBLY BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. 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 10368716 ↗
• MalfunctionNov 21, 2019Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN DELIVERY MICROCATHETER (LANTERN). UPON ADVANCEMENT OF THE NEXT RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT IT WOULD NOT ADVANCE PAST THE MIDDLE OF THE LANTERN. HOWEVER, THE PHYSICIAN CONTINUED TO TRY TO PUSH THE RUBY COIL FORWARD AND REPORTED THAT IT UNINTENTIONALLY DETACHED IN THE LANTERN. THE PHYSICIAN THEN FLUSHED THE RUBY COIL OUT OF THE LANTERN AND INTO THE TARGET VESSEL USING A 2CC SYRINGE. THE RUBY COIL WAS IMPLANTED SUCCESSFULLY. 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 9354603 ↗