RUBY Coil RBY4C1240-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI M424RBY4C12400), received between Mar 3, 2016 and Jul 21, 2021 — classified as 1 injury, 14 malfunctions.

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

• MalfunctionJul 21, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FEMORAL ARTERY AND THE ILIAC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE DETACHED RUBY COIL WAS REMOVED FROM THE MICROCATHETER USING A GUIDEWIRE. NEXT, WHILE ADVANCING A NEW RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK AND SUBSEQUENTLY UNINTENTIONALLY DETACHED IN THE MICROCATHETER, WITH APPROXIMATELY HALF OF A CENTIMETER OF THE RUBY COIL IN THE PATIENT. THEREFORE, THE DETACHED RUBY COIL WAS REMOVED FROM THE MICROCATHETER USING THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING A LIQUID EMBOLIC AGENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207920 ↗
• MalfunctionDec 18, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING RUBY COILS, AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL PAST THE PROXIMAL END OF THE VELOCITY, AND EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, POD COIL, AND THE SAME VELOCITY. 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 11042036 ↗
• MalfunctionMar 27, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE SEVENTH RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COIL AND THEN REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING THREE 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 9891595 ↗
• MalfunctionFeb 22, 2019Retraction Problem; Failure to Advance; Physical Resistance/Sticking; Retraction Problem; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL MORE THAN 2/3 OF THE WAY THROUGH THE LANTERN. THE RUBY COIL WAS THEN RETRACTED AND RE-ADVANCED, HOWEVER IT BECAME STUCK AT THE SAME PLACE WITHIN THE LANTERN. THE RUBY COIL WAS THEN REMOVED AND THE LANTERN WAS FLUSHED. UPON ADVANCEMENT OF ANOTHER RUBY COIL THROUGH THE LANTERN, THE SAME ISSUE OCCURRED. THIS RUBY COIL WAS ALSO REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A THIRD RUBY COIL THROUGH THE LANTERN, AND THE SAME ISSUE AGAIN OCCURRED. THE THIRD RUBY COIL WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME LANTERN. AFTER THE PROCEDURE, THE RUBY COILS WERE INSPECTED AND WERE FOUND TO HAVE VISIBLE DISINTEGRATION OF THE COIL BRAID NEAR THE DETACHMENT ZONE. IT WAS ALSO REPORTED THAT NO PIECES OF THE DAMAGED COILS WERE LEFT IN THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362721 ↗
• MalfunctionNov 27, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, ONE RUBY COIL AND ONE POD PACKING COIL BECAME KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE COILS OCCURRED PRIOR TO USE AND, THEREFORE, THEY WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8108741 ↗
• MalfunctionAug 17, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL TECHNOLOGIST ACCIDENTALLY KINKED THE RUBY COIL UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE. 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 7793457 ↗
• MalfunctionMar 12, 2018Electrical Overstress; Mechanical Jam; Electrical Overstress; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED THREE RUBY COILS USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). ANOTHER RUBY COIL THEN BECAME STUCK WITHIN THE PX SLIM, AND THEREFORE THE PX SLIM WAS REMOVED WITH THE RUBY COIL INSIDE. THE PROCEDURE THEN ENDED AT THIS POINT BECAUSE THE EXISTING COIL MASS WAS SUFFICIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7332441 ↗
• MalfunctionMar 9, 2018Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT AND LEFT SUBCLAVIAN ARTERIES USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL, THE PHYSICIAN RETRACTED IT FROM THE RIGHT SUBCLAVIAN ARTERY BECAUSE THE RUBY COIL WAS THE WRONG SIZE. HOWEVER, UPON REMOVAL FROM THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE RUBY COIL BECAME KINKED. THIS SAME ISSUE THEN OCCURRED WITH A SECOND RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO PLACE A RUBY COIL IN THE LEFT SUBCLAVIAN ARTERY, HOWEVER THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED UPON INSERTION INTO A LANTERN; THEREFORE, IT WAS REMOVED. THIS SAME ISSUE THEN OCCURRED WITH ANOTHER RUBY COIL, AND THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329094 ↗
• MalfunctionMar 7, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ATTEMPTED TO DEPLOY FOUR OTHER RUBY COILS, HOWEVER WAS UNABLE TO DUE TO THE EXTREME ANGLE OF ACCESS INTO THE ANEURYSM, DESPITE MAKING MULTIPLE ADJUSTMENTS TO THE PLACEMENT OF THE LANTERN. CONSEQUENTLY, THE PHYSICIAN FELT RESISTANCE AND THE RUBY COILS UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN REMOVED THE LANTERN TO PULL OUT EACH OF THE FOUR DETACHED RUBY COILS, AND REINSERTED THE SAME LANTERN. THE PROCEDURE WAS THEN COMPLETED USING THE SAME LANTERN AND ADDITIONAL RUBY COILS AFTER THE ACCESS SHEATH WAS ADJUSTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321485 ↗
• MalfunctionMar 7, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ATTEMPTED TO DEPLOY FOUR OTHER RUBY COILS, HOWEVER WAS UNABLE TO DUE TO THE EXTREME ANGLE OF ACCESS INTO THE ANEURYSM, DESPITE MAKING MULTIPLE ADJUSTMENTS TO THE PLACEMENT OF THE LANTERN. CONSEQUENTLY, THE PHYSICIAN FELT RESISTANCE AND THE RUBY COILS UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN REMOVED THE LANTERN TO PULL OUT EACH OF THE FOUR DETACHED RUBY COILS, AND REINSERTED THE SAME LANTERN. THE PROCEDURE WAS THEN COMPLETED USING THE SAME LANTERN AND ADDITIONAL RUBY COILS AFTER THE ACCESS SHEATH WAS ADJUSTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321474 ↗
• MalfunctionJan 31, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN DECIDED TO REPOSITION THE LANTERN AND THEREFORE REMOVED THE RUBY COIL. THE RUBY COIL WAS RE-SHEATHED AND PLACED IN A BOWL OF SALINE. IT WAS REPORTED THAT THERE WAS NOTICEABLE BLOOD ON THE COIL AND IN THE INTRODUCER SHEATH. THE PHYSICIAN THEN REPOSITIONED THE LANTERN AND DECIDED TO PLACE THE SAME RUBY COIL AGAIN, HOWEVER THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN. THE RUBY COIL WAS THEREFORE REMOVED, AND 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 Consequences Or Impact To Patient

  MAUDE report 7232692 ↗
• MalfunctionJul 6, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERN'S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) AND INTO THE LANTERN, THE TECHNOLOGIST ENCOUNTERED RESISTANCE AND REMOVED THE COILS. THE PHYSICIAN THEN LOOSENED THE RHV ON THE NEURON 070 CATHETER (NEURON 070) AND RAN A GUIDEWIRE DOWN THE LANTERN WITHOUT ANY RESISTANCE. A NEW RUBY COIL WAS THEN OPENED AND RESISTANCE WAS ENCOUNTERED AT THE RHV CONNECTION ON THE NEURON 070. SUBSEQUENTLY, THE LANTERN WAS REMOVED AND A NEW LANTERN WAS OPENED FOR THE PROCEDURE. IT WAS REPORTED THAT A KINK WAS OBSERVED NEAR THE HUB OF THE FIRST LANTERN. NEXT, THE PHYSICIAN DEPLOYED A NEW RUBY COIL INTO THE ANEURYSM BUT DETERMINED THAT THE COIL WAS THE INCORRECT SIZE. THE RUBY COIL WAS REMOVED AND A NEW RUBY COIL WAS OPENED. WHILE ATTEMPTING TO ADVANCE THIS COIL INTO THE LANTERN, THE TECHNOLOGIST ENCOUNTERED RESISTANCE AND REMOVED THE COIL. A NEW RUBY COIL WAS OPENED AND RESISTANCE WAS ENCOUNTERED AGAIN WHILE THE TECHNOLOGIST WAS ATTEMPTING TO LOAD THE COIL INTO THE LANTERN. THE COIL STOPPED ADVANCING AT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6689899 ↗
• MalfunctionSep 7, 2016Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Physical Resistance; Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A RUBY COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER , THE PHYSICIAN NOTICED THE RUBY COIL WAS TOO BIG FOR THE ANEURYSM, THEREFORE IT WAS REMOVED. HOWEVER, WHILE RESHEATHING THE RUBY COIL OUTSIDE OF THE PATIENT'S BODY, THE TECHNOLOGIST EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY A DIFFERENT SIZE RUBY COIL IN THE ANEURYSM; HOWEVER, THE RUBY COIL WAS TOO BIG FOR THE ANEURYSM AND IT WAS REMOVED. UPON ATTEMPTING TO RESHEATH THIS RUBY COIL, THE TECHNOLOGIST EXPERIENCED RESISTANCE AGAIN AND THE RUBY COIL UNINTENTIONALLY DETACHED AS WELL. THE PROCEDURE WAS THEN COMPLETED USING NEW RUBY COILS AND THE SAME LANTERN DELIVERY MICROCATHETER. THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV), HOWEVER, THE MICROCATHETER WAS FLUSHED AFTER EVERY COIL. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5932789 ↗
• InjuryJun 30, 2016Detachment Of Device Component; Fracture; Physical Resistance; Detachment Of Device Component; Fracture; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DELIVERED THREE RUBY COILS IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ADVANCING A NEW RUBY COIL IN THE TARGET VESSEL USING THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE. WHEN THE RUBY COIL WAS ALMOST DEPLOYED IN THE TARGET VESSEL, IT UNINTENTIONALLY DETACHED WITH PART OF IT IN THE PX SLIM AND PART IN THE ANEURYSM. AFTER A FAILED ATTEMPT TO WITHDRAW THE DIAGNOSTIC CATHETER IN ORDER TO RETRIEVE THE DETACHED RUBY COIL, THE PHYSICIAN DECIDED TO USE A WIRE. THE PHYSICIAN PUSHED THE DETACHED RUBY COIL THROUGH THE PX SLIM USING THE WIRE; HOWEVER, IT WAS UNABLE TO REMOVE THE DETACHED RUBY COIL. THE PHYSICIAN THEN DECIDED TO REMOVE THE PX SLIM; HOWEVER, WHILE REMOVING THE PX SLIM, THE RUBY COIL FRACTURED. THERE WAS STILL PART OF THE RUBY COIL OUT OF THE DIAGNOSTIC CATHETER; THEREFORE, THE PHYSICIAN ATTEMPTED TO PULL IT. WHILE PULLING THE RUBY COIL, THE WIRE TORE OFF AND PART OF THE RUBY COIL WAS STILL IN THE DIAGNOSTIC CATHETER AND THE OTHER PART WAS IN THE ANEURYSM. AFTER SEVERAL FAILED ATTEMPTS TO CAPTURE THE RUBY COIL USING A SNARE DEVICE, T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5761686 ↗
• MalfunctionMar 3, 2016Failure 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 ANOTHER MANUFACTURER'S MICROCATHETER AND THEY WERE BOTH REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5478089 ↗