RUBY Coil RBY2C1857-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00814548019260), received between Oct 29, 2018 and Oct 20, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Migration; Premature Separation; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) ANEURYSM USING A RUBY COIL, A RUBY XL, A NON-PENUMBRA CATHETER (5F), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY XL THROUGH THE 5F NON-PENUMBRA CATHETER, AND THE RUBY XL WAS REMOVED. THE PHYSICIAN THEN INSERTED THE LANTERN THROUGH THE NON-PENUMBRA CATHETER AND PLACED THREE RUBY COILS IN THE TARGET LOCATION USING THE LANTERN. WHILE ADVANCING ANOTHER RUBY COIL INTO THE TARGET LOCATION, THE LANTERN HAD KICKED OUT OF THE VESSEL AND THE RUBY COIL UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE DETACHED RUBY COIL MIGRATED FROM THE GDA TO THE HEPATIC ARTERY. THE PHYSICIAN WAS ABLE TO REMOVE THE DETACHED RUBY COIL USING A SNARE DEVICE AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN DETERMINED THAT THE ANEURYSM WAS OCCLUDED ENOUGH AND ENDED 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 23334167 ↗
• MalfunctionJun 2, 2023Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT OF THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND RUBY COIL INTO THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE LANTERN CONTAINING THE SECOND RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT OF THE LANTERN. 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 17056436 ↗
• MalfunctionJun 2, 2023Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT OF THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND RUBY COIL INTO THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE LANTERN CONTAINING THE SECOND RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT OF THE LANTERN. 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 17056433 ↗
• MalfunctionJan 19, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROINTESTINAL VARICOSE VEINS USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN USED SALINE TO FLUSH THE LANTERN AND PUSH THE DETACHED RUBY COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING NEW 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 16211443 ↗
• MalfunctionAug 19, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL WOULD NOT ADVANCE THROUGH ITS INTRODUCER SHEATH. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12344276 ↗
• MalfunctionAug 10, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK SAC USING RUBY COILS, PACKING COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED SEVERAL RUBY COILS IN THE TARGET LOCATION. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE INTRODUCER SHEATH, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL, PACKING 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 12304431 ↗
• MalfunctionJul 15, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER AND SUBSEQUENTLY THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 12173853 ↗
• MalfunctionMay 20, 2021Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIAC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE LANTERN THROUGH THE CATHETER, FOLLOWED BY IMPLANTING ONE COIL IN THE ANEURYSM. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED DIFFICULTY PUSHING THE NEXT COIL, A RUBY COIL, THROUGH THE SAME LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN DID NOT USE A NEW COIL AS THEY WERE GOING TO PLACE STENT ACROSS THE ANEURYSM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11858040 ↗
• MalfunctionFeb 24, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A SHEATH. DURING THE PROCEDURE, THE FIRST RUBY COIL WOULD NOT ADVANCE PAST THE MIDDLE OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, TWO RUBY COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. NEXT, TWO RUBY COILS WOULD NOT ADVANCE PAST THE MIDDLE OF THE LANTERN. THEREFORE, THESE RUBY COILS WERE REMOVED. THE PHYSICIAN DECIDED TO REMOVE THE LANTERN AND, UPON REMOVAL, THE PHYSICIAN NOTICED THE LANTERN WAS KINKED PROXIMAL TO THE HUB. THEREFORE, THE LANTERN WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN USED A NEW LANTERN TO SUCCESSFULLY IMPLANT ONE RUBY COIL. HOWEVER, THE NEXT RUBY COIL WOULD NOT ADVANCE PAST THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, ANOTHER RUBY COIL, AND THE SAME SHEATH. 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 11376231 ↗
• MalfunctionFeb 13, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. 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; No Consequences Or Impact To Patient

  MAUDE report 11325904 ↗
• MalfunctionJan 21, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN KINKED THE RUBY COIL PUSHER WIRE WHEN THE COIL WAS IN THE PROXIMAL END OF THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE 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; No Consequences Or Impact To Patient

  MAUDE report 11211385 ↗
• MalfunctionSep 4, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE COILS INTO THE TARGET VESSEL. WHILE ATTEMPTING TO INTRODUCE THE LAST RUBY COIL TO THE TARGET VESSEL, THE PUSHER ASSEMBLY BECAME KINKED AT A NINETY DEGREE ANGLE APPROXIMATELY TEN CENTIMETERS FROM THE PROXIMAL END. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL 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 10495139 ↗
• MalfunctionOct 29, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL THROUGH THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED; THEREFORE, THE 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 9251947 ↗
• MalfunctionMay 29, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT VARICES USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER, THE HOSPITAL TECHNOLOGIST EXPERIENCED DIFFICULTY AND STOPPED IMMEDIATELY PUSHING THE RUBY COIL. THEREFORE, THE RUBY COIL WAS RETRACTED BACK INTO ITS INTRODUCER SHEATH AND THE MICROCATHETER FLUSHED. A SECOND ATTEMPT WAS THEN MADE AND THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THE RUBY COIL WAS ADVANCED APPROXIMATELY FIVE TO TEN CENTIMETERS WITHIN ITS INTRODUCER SHEATH THEN IT BECAME DIFFICULT TO PUSH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL 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 8649590 ↗
• MalfunctionFeb 22, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE TO TREAT VARICES USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE PAST THE HUB OF A LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE, IT 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 8363947 ↗
• MalfunctionOct 29, 2018Device Damaged Prior to Use; Device Handling Problem; Device Damaged Prior to Use; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A HOSPITAL STAFF NOTICED THAT TWO RUBY COILS WERE ACCIDENTALLY UNSHEATHED UPON REMOVAL FROM THE DISPENSER HOOPS. THE REPORTED ISSUE WAS FOUND PRIOR TO USE AND PRIOR TO PATIENT INVOLVEMENT. THEREFORE, THE RUBY COILS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8017614 ↗