RUBY Coil RBY2C4060-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00814548019437), received between Oct 18, 2018 and Sep 10, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (11 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.

• MalfunctionSep 10, 2026Premature Separation

  The patient was undergoing a coil embolization procedure in the aortic false lumen using a Ruby Coil, and a Lantern Delivery Microcatheter (Lantern). The Ruby Coil would not advance beyond a certain point within the Lantern. Therefore, the physician attempted to retract the coil. While retracting the coil back, the Ruby Coil unintentionally detached within the microcatheter. Therefore, the Lantern containing the detached the Ruby Coil was removed. The procedure was completed at this point. There was no report of an adverse effect to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50712638 ↗
• MalfunctionSep 13, 2021Stretched; Separation Failure; Physical Resistance/Sticking; Stretched; Separation Failure; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN AND INFERIOR VENA CAVA (IVA) SHUNT USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND STENOSED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL INTO THE TARGET LOCATION USING THE HANDLE. WHILE ATTEMPTING TO IMPLANT THE NEXT RUBY COIL, THE HANDLE FAILED TO DETACH THE COIL. IT WAS ALSO REPORTED THAT THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK INSIDE THE HANDLE. WHILE ATTEMPTING TO REMOVE THE RUBY COIL, THE PHYSICIAN REALIZED THAT THE COIL WAS STRETCHED INSIDE THE LANTERN. THEREFORE, THE LANTERN AND THE RUBY COIL WERE REMOVED TOGETHER FROM THE PATIENT. THE HANDLE WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, FIVE RUBY COILS, ANOTHER HANDLE, AND SIXTEEN NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465106 ↗
• MalfunctionJul 6, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING RUBY COILS, POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH A POD COIL; THEREFORE, THE POD COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, 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 12124592 ↗
• MalfunctionMay 17, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GASTRIC VARICES USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE RETRACTING A RUBY COIL TO REPOSITION IT, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. 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 11838689 ↗
• MalfunctionMar 16, 2021Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE OF AN ABERNATHY MALFORMATION SHUNT USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY ADVANCING THE LANTERN TO THE TARGET LOCATION DUE TO THE TORTUOSITY OF THE VESSEL. SUBSEQUENTLY, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE DETACHED RUBY COIL. UPON FURTHER INSPECTION, THE PHYSICIAN NOTICED THE DISTAL TIP OF THE LANTERN TO BE KINKED. THEREFORE, THE LANTERN WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN 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 11498963 ↗
• MalfunctionJan 25, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING RUBY COILS AND POD PACKING COILS (POD PCS). DURING THE PROCEDURE, IT WAS REPORTED THAT A RUBY COIL WOULD NOT TAKE SHAPE IN THE TARGET VESSEL AND WOULD RUN DOWN THE VISCERAL VESSEL. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, A POD PC PUSHER WIRE BECAME BENT UPON REMOVAL FROM ITS PACKAGING HOOP. THEREFORE, THE POD PC WAS NOT USED IN THE PROCEDURE. IT WAS ALSO REPORTED THAT ANOTHER POD PC WAS UNABLE TO FIT IN THE COIL PACK; THEREFORE, THE POD PC WAS REMOVED FROM THE PATIENT. WHILE ATTEMPTING TO ADVANCE ANOTHER POD PC INTO THE TARGET LOCATION, THE COIL DETACHED OUTSIDE OF THE MICROCATHETER (UNKNOWN). THEREFORE, THE MICROCATHETER AND THE POD PC WERE REMOVED TOGETHER FROM THE PATIENT AND THE POD PC WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. 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 11227154 ↗
• MalfunctionNov 28, 2020Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN AN ENDOLEAK SAC USING RUBY COILS, POD PACKING COILS (POD PC), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE LANTERN THROUGH THE DIAGNOSTIC CATHETER. IT WAS REPORTED THAT THE ACCESS WAS PERCUTANEOUS AND SHALLOW. CONSEQUENTLY, WHEN THE PHYSICIAN EXPERIENCED ANY RESISTANCE, THE RESISTANCE WOULD KICK THE DIAGNOSTIC CATHETER OUT. WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN LOST ACCESS TO THE SAC AND REMOVED THE ENTIRE SYSTEM. ONCE ON THE BACK TABLE, UPON ATTEMPTING TO RECAPTURE THE RUBY COIL, THE PUSHER ASSEMBLY OF THE RUBY COIL WAS INADVERTENTLY KINKED. AN ATTEMPT WAS MADE TO STRAIGHTEN THE PUSHER ASSEMBLY, AND THE RUBY COIL BROKE. SUBSEQUENTLY, THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING A NEW RUBY COIL. NEXT, WHILE ADVANCING A POD PC THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE LANTERN KINKED, WHICH CAUSED THE POD PC TO BECAME STUCK IN THE LANTERN. THE POD PC AND LANTERN WERE REMOVED. ON THE BACK TABLE, WHILE REMOVING THE POD PC FROM THE LANTERN, THE POD PC BROKE. THEREFORE, THE POD PC AND LANTERN

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10915332 ↗
• MalfunctionJul 1, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE PATIENT ANATOMY WAS SEVERELY TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL APPROXIMATELY 30 CENTIMETERS INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL AND LANTERN. UPON REMOVAL, THE RUBY COIL APPEARED TO BE FINE; HOWEVER, THE LANTERN WAS KINKED APPROXIMATELY 8.5 CENTIMETERS FROM THE DISTAL TIP. THEREFORE, THE LANTERN WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. WHILE RE-ADVANCING THE SAME RUBY COIL THROUGH A NEW LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE RUBY COILS, ONE OTHER COIL AND THE SECOND LANTERN, FOLLOWED BY A STENT GRAFT. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE COMPLETING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10221293 ↗
• MalfunctionJan 24, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE I ENDOLEAK USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL THROUGH THE LANTERN INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE RESULT. THEREFORE, THE RUBY COIL WAS RETRACTED, RE-SHEATHED AND PLACED IN A BOWL OF HEPARINIZED SALINE. LATER IN THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO REUSE THE PREVIOUSLY REMOVED RUBY COIL AND NOTICED THAT THE RUBY COIL WAS KINKED; THEREFORE THE RUBY COIL WAS NOT USED. NEXT, A NEW RUBY COIL WAS PLACED SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL IN THE TARGET VESSEL BUT DECIDED TO REPOSITION THE RUBY COIL; THEREFORE, THE RUBY COIL WAS REMOVED, RE-SHEATHED AND RINSED IN SALINE. WHILE ATTEMPTING TO RE-ADVANCE THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE RUBY COIL WAS REMOVED AND NOT USED. 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 9625515 ↗
• MalfunctionDec 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PELVIC ARTERIOVENOUS FISTULA (AVF) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER AND THEN ADVANCED ANOTHER RUBY COIL. SUBSEQUENTLY, WHILE RETRACTING THE RUBY COIL THROUGH THE MICROCATHETER TO REPOSITION IT, THE PHYSICIAN ENCOUNTERED RESISTANCE. IT WAS REPORTED THAT SINCE THE RUBY COIL COULD ONLY MOVE FORWARD, THE PHYSICIAN CONTINUED ADVANCING IT AGAINST RESISTANCE AND WAS ABLE TO SUCCESSFULLY PLACE THE RUBY COIL IN THE TARGET VESSEL. 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 Consequences Or Impact To Patient

  MAUDE report 9451227 ↗
• MalfunctionDec 9, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED PENUMBRA COILS IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE NEXT RUBY COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AT 30CM FROM THE TIP OF THE LANTERN; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL AND FLUSHED IT WITH SALINE. WHILE RE-ADVANCING THE RUBY COIL, IT WOULD NOT ADVANCE IN THE LANTERN; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER PENUMBRA 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 9438889 ↗
• MalfunctionOct 8, 2019Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SEVENTEEN RUBY COILS IN THE AVM USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING THE EIGHTEENTH RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN CONTINUED TO ADVANCE THE RUBY COIL AGAINST RESISTANCE, AND CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BROKE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9169864 ↗
• MalfunctionJun 14, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO TRACK THE LANTERN THROUGH A NON-PENUMBRA DIAGNOSTIC CATHETER. THEREFORE, THE PHYSICIAN EXCHANGED FOR A NEW LANTERN AND A NEW DIAGNOSTIC CATHETER. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEW LANTERN THROUGH THE NEW DIAGNOSTIC CATHETER. NEXT, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL BECAME STUCK INSIDE OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS WITH THE SAME LANTERN AND DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700339 ↗
• MalfunctionFeb 7, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN A LANTERN DELIVERY MICROCATHETER (LANTERN) AND, THEREFORE, THE RUBY COIL WAS REMOVED. UPON REMOVAL, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED. THE PROCEDURE WAS THEREFORE COMPLETED USING NEW 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 8318777 ↗
• MalfunctionDec 10, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL DETACHED FROM ITS PUSHER ASSEMBLY UPON REMOVAL FROM THE DISPENSER HOOP. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8147521 ↗
• MalfunctionOct 18, 2018Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A RUBY COIL. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A LANTERN UP TO THE TARGET VESSEL BUT ULTIMATELY WAS ABLE TO ADVANCE IT. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK INSIDE THE LANTERN; THEREFORE, BOTH LANTERN AND RUBY COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED BY PLACING A STENT DEVICE OVER THE ANEURYSM AND A VASCULAR GRAFTS WITHIN THE COMMON FEMORAL INTO THE AORTA. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7979318 ↗