RUBY Coil RBY2C0630-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00814548018812), received between Oct 3, 2018 and Mar 26, 2026 — classified as 1 injury, 9 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.

• MalfunctionMar 26, 2026Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN PLACED ONE RUBY COIL IN THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN WAS THEN ADVANCING A NEW RUBY COIL THROUGH THE LANTERN AND KINKED THE PUSHER ASSEMBLY OF THE EMBOLIZATION COIL. UPON RETRACTING THE PUSHER ASSEMBLY, THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE USING A NEW POD COIL AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708541 ↗
• InjuryApr 19, 2024Migration; Premature Separation; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN THOUGHT THAT THE ENTIRE RUBY COIL WAS PLACED IN THE TARGET LOCATION USING THE HANDLE; HOWEVER, WHILE REMOVING THE MICROCATHETER, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN DECIDED TO REMOVE THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL. WHILE REMOVING, THE RUBY COIL MIGRATED TO A BRANCH IN THE GDA. NO ATTEMPTS WERE MADE TO REMOVE THE DETACHED RUBY COIL. THE COIL EMBOLIZATION PROCEDURE ENDED AT THIS POINT. THE PATIENT WAS BROUGHT BACK ON (B)(6) 2024 FOR A RADIOEMBOLIZATION (Y90) PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19149587 ↗
• MalfunctionFeb 9, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT PELVIC VARICOSE VEINS USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO COILS INTO THE TARGET LOCATION USING THE LANTERN. AFTER ADVANCING THE RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED VIA FLUOROSCOPY THAT THE RUBY COIL HAD BECOME UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED FROM THE PATIENT. THE PHYSICIAN ATTEMPTED TO ADVANCE A GUIDEWIRE THROUGH THE SAME LANTERN AND REPORTED THAT THE GUIDEWIRE WOULD NOT PASS. THE PHYSICIAN THEN REMOVED THE LANTERN FROM THE PATIENT AND FOUND THAT THE LANTERN WAS KINKED MID-SHAFT. THE PHYSICIAN USED A NEW LANTERN TO IMPLANT FIVE ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677465 ↗
• MalfunctionJun 15, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS, POD PACKING COILS (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE RUBY COIL WAS REMOVED USING A SNARE DEVICE. IT WAS REPORTED THAT EITHER ANOTHER RUBY COIL OR THE POD PC UNINTENTIONALLY DETACHED; HOWEVER, THE COIL WAS POSITIONED IN AN ACCEPTABLE LOCATION WITHIN THE PATIENT'S ANATOMY AND WAS NOT REQUIRED TO BE REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691459 ↗
• MalfunctionMay 7, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HEPATIC ARTERY USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE PENUMBRA COILS IN THE TARGET LOCATION USING THE LANTERN. IT WAS REPORTED THAT THE LANTERN WAS NOT FLUSHED. NEXT, WHILE ADVANCING A RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND THE PUSHER ASSEMBLY OF THE RUBY COIL AS A UNIT. IT WAS REPORTED THAT THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT A PORTION OF THE DETACHED RUBY COIL REMAINED IN THE GUIDE CATHETER. SUBSEQUENTLY, THE PHYSICIAN NOTICED THE LANTERN WAS FRACTURED PROXIMAL TO THE HUB. THE PHYSICIAN THEN USED A SNARE DEVICE TO PUSH THE DETACHED PORTION OF THE RUBY COIL INTO THE ANEURYSM. 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 14322749 ↗
• MalfunctionOct 1, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE WITHIN THE INTRODUCER SHEATH. 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 12565663 ↗
• MalfunctionNov 30, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE RUBY COIL INTO THE ANEURYSM. WHEN THE COIL WAS HALFWAY INSIDE THE ANEURYSM, THE PHYSICIAN ENCOUNTERED RESISTANCE AND PULLED IT BACK. SUBSEQUENTLY, THE RUBY COIL DETACHED INSIDE THE LANTERN. NEXT, A SYRINGE WAS USED TO FLUSH THE RUBY COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING MORE 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; No Consequences Or Impact To Patient

  MAUDE report 10920487 ↗
• MalfunctionFeb 12, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEED IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA CATHETER, THE RUBY COIL WAS COILING INSIDE THE CATHETER AND WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COILS; THEREFORE, THE RUBY COILS AND THE CATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND FOUR ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8331141 ↗
• MalfunctionFeb 6, 2019Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT ARTERIOVENOUS (AV) FISTULAS IN THE PATIENT¿S LEG USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE VESSELS WERE DIFFICULT TO ACCESS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY POSITIONED A GUIDEWIRE, NON-PENUMBRA CATHETER, AND A LANTERN INTO THE TARGET VESSEL AND DEPLOYED FOUR RUBY COILS. THE TECHNICIAN THEN FELT RESISTANCE WHILE ADVANCING THE FIFTH RUBY COIL AND WAS ONLY ABLE TO ADVANCE 90% OF THE COIL INTO THE LANTERN BEFORE THE RUBY COIL BECAME KINKED. THE RUBY COIL WAS THEREFORE REMOVED. WHILE ADVANCING THE SIXTH RUBY COIL, THE TECHNICIAN AGAIN FELT RESISTANCE AND SAME ISSUE OCCURRED. THE SIXTH RUBY COIL WAS, THEREFORE, REMOVED. THE LANTERN WAS THEN REMOVED FROM THE PATIENT AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE LANTERN AND NO VISIBLE DAMAGE; HOWEVER, THE LANTERN WAS SET ASIDE AND A NEW LANTERN WAS USED TO CONTINUE THE PROCEDURE. THE SAME GUIDEWIRE AND THE SAME NON-PENUMBRA CATHETER WERE ALSO USED. THE PHYSICIAN THEN DECIDED TO RE-POSITION THE GUIDEWIRE, NON-PENUMBRA CATHETER, AND NEW LANTERN TOGETHER IN ORDER TO REGAIN ACCESS TO THE TARGET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313258 ↗
• MalfunctionOct 3, 2018Separation 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 WAS UNABLE TO DEPLOY A RUBY COIL USING THE HANDLE AND, THEREFORE, THE RUBY COIL WAS REMOVED. 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 7931955 ↗