RUBY Coil RBY2C0410-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814548018577), received between Feb 12, 2019 and Apr 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE SUPERIOR MESENTERIC ARTERY (SMA) USING A RUBY COIL, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK. THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL AND NOTICED THAT THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE RUBY COIL WAS FLUSHED OUT OF THE MICROCATHETER USING A 3CC SYRINGE ON THE BACK TABLE AND THE MICROCATHETER WAS FLUSHED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 21877961 ↗
• MalfunctionFeb 7, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS, POD PACKING COILS (PACKING COIL), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER; THE PHYSICIAN MET RESISTANCE. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN SUCCESSFULLY FLUSHED THE DETACHED RUBY COIL INTO THE TARGET VESSEL. NEXT, AFTER REMOVING THE RUBY COIL'S PUSHER ASSEMBLY, THE PHYSICIAN BEGAN ADVANCING A PACKING COIL THROUGH THE MICROCATHETER. HOWEVER; RESISTANCE WAS FELT AND THE COIL STOPPED ADVANCING AT THE PROXIMAL LOCATION OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE PACKING COIL. THE MICROCATHETER WAS THEN REMOVED. UPON INSPECTION, THE PHYSICIAN NOTICED THE RUBY COIL'S PUSHER ASSEMBLY HAD FRACTURED AND HALF REMAINED WITHIN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH 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 21337152 ↗
• MalfunctionApr 5, 2022Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ARTERIOVENOUS FISTULA (AVF) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THE HOSPITAL TECHNICIAN BENT THE PUSHER ASSEMBLY OF THE RUBY COIL AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SYRINGE TO ASPIRATE AND REMOVE THE DETACHED RUBY COIL. THE SAME ISSUE THEN OCCURRED WITH THE NEXT RUBY COIL. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT. 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 14016071 ↗
• MalfunctionApr 5, 2022Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ARTERIOVENOUS FISTULA (AVF) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THE HOSPITAL TECHNICIAN BENT THE PUSHER ASSEMBLY OF THE RUBY COIL AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SYRINGE TO ASPIRATE AND REMOVE THE DETACHED RUBY COIL. THE SAME ISSUE THEN OCCURRED WITH THE NEXT RUBY COIL. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT. 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 14016067 ↗
• MalfunctionDec 2, 2021Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A RUBY COIL, A RUBY COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5FR NON-PENUMBRA SHEATH, A 5FR NON-PENUMBRA GUIDE CATHETER, AND A NON-PENUMBRA GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS EXTREMELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SHEATH INTO THE RIGHT GROIN, ADVANCED THE GUIDE CATHETER THROUGH THE SHEATH, AND ADVANCED THE MICROCATHETER TO THE TARGET VESSEL THROUGH THE GUIDE CATHETER. THE PHYSICIAN THEN FLUSHED THE RUBY COIL AND MICROCATHETER WITH SALINE ON THE BACK TABLE. WHILE RE-ATTEMPTING TO ADVANCE THE RUBY COIL TO THE TARGET VESSEL USING THE MICROCATHETER, THE RUBY COIL BECAME STUCK AND WOULD NOT EXIT THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE RUBY COIL AND FLUSHED THE MICROCATHETER AGAIN WITH SALINE. WHILE ATTEMPTING TO RE-ADVANCE THE RUBY COIL, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 12920879 ↗
• MalfunctionMar 19, 2021Failure to Fold; Difficult to Remove; Physical Resistance/Sticking; Failure to Fold; Difficult to Remove; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE TARGET ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED SIZING ISSUES WITH OTHER PENUMBRA COILS; THEREFORE, THESE COILS WERE NOT IMPLANTED AND WERE REMOVED FROM THE PROCEDURE. WHILE IMPLANTING THE FIRST POD COIL, IT WOULD NOT FORM IN THE VESSEL. THE PHYSICIAN DECIDED TO REMOVE THE POD COIL AND, WHILE RETRACTING THE COIL BACK INTO THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. AFTER REMOVING THE POD COIL, THE PHYSICIAN ATTEMPTED TO IMPLANT A RUBY COIL AND REPORTED THAT THE COIL ALSO DID NOT FORM IN THE VESSEL. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE RUBY COIL. THE PHYSICIAN WAS UNABLE TO RETRACT THE RUBY COIL BACK INTO THE MICROCATHETER AT FIRST, BUT EVENTUALLY DID AND SUBSEQUENTLY REMOVED THE RUBY COIL FROM THE PROCEDURE. THE PROCEDURE CONTINUED WITH OTHER PENUMBRA COILS; HOWEVER, THE PHYSICIAN EXPERIENCED SIZING ISSUES WITH THESE COILS. THEREFORE, THE PENUMBRA COILS WITH SIZING ISSUES WERE NOT IMPLANTED AND WERE REMOVED FROM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11531996 ↗
• MalfunctionMar 11, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT PULMONARY ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE VESSEL USING THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT ANCHOR AGAINST THE VESSEL AND TAKE ITS INTENDED SHAPE THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL INTO THE TARGET LOCATION; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11466911 ↗
• MalfunctionJul 26, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A POD3, RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN OPENED THE PACKAGING AND THE LANTERN WAS INADVERTENTLY DROPPED ON THE FLOOR. THEREFORE, THE LANTERN WAS NOT USED IN THE PROCEDURE. NEXT, THE PHYSICIAN PLACED A NEW LANTERN IN THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A POD3; HOWEVER, THE COIL WOULD NOT TAKE ITS INTENDED SHAPE. THEREFORE, THE POD3 WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED, AND THE COIL WOULD NOT TAKE ITS INTENDED SHAPE, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NON-PENUMBRA EMBOLIC AGENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8832869 ↗
• MalfunctionFeb 12, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH TORTUOUS ANATOMY INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND USED A HANDLE TO DETACH IT; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED RUBY COIL. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT RUBY COIL AND; THEREFORE, THE PHYSICIAN MANUALLY DETACHED IT. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL RUBY COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8333890 ↗