RUBY Coil RBY2C2860-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00814548019314), received between Jan 31, 2019 and Oct 15, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC VEIN (SMV) USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL IN THE TARGET VESSEL, THE PHYSICIAN RETRACTED THE COIL SLIGHTLY IN AN ATTEMPT TO RE-POSITION IT AND REALIZED UNDER FLUOROSCOPY THAT THE RUBY COIL WAS UNINTENTIONALLY DETACHED INSIDE THE DISTAL END OF THE LANTERN. THE PHYSICIAN THEN USED THE RUBY COIL PUSHER WIRE TO PUSH THE DETACHED COIL OUT OF THE LANTERN INTO THE TARGET LOCATION. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20457285 ↗
• MalfunctionJul 21, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VEIN USING A RUBY COIL, A NON-PENUMBRA MICROCATHETER, A GUIDING SHEATH, AND A BALLOON GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. NEXT, WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE PROXIMAL END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL WAS REMOVED. ON THE BACK TABLE, UPON PULLING THE RUBY COIL OUT FROM THE MICROCATHETER, THE PHYSICIAN NOTICED THE RUBY COIL WAS NO LONGER ATTACHED TO THE PUSHER ASSEMBLY AND HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN FLUSHED THE MICROCATHETER AND REMOVED THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPETED 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 17375331 ↗
• MalfunctionNov 11, 2022Premature Separation; Premature Separation

  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 FIRST RUBY COIL WAS ADVANCED INTO THE LANTERN AND BECAME STUCK AT THE DISTAL END. THEREFORE, THE LANTERN CONTAINING THE RUBY COIL WAS REMOVED. ON THE BACK TABLE, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED IN THE LANTERN. THE DETACHED RUBY COIL WAS REMOVED FROM THE LANTERN WITH DIFFICULTY AND THE LANTERN WAS EXAMINED BEFORE BEING RE-ADVANCED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL OF THE SAME SIZE, SIX OTHER 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 15784917 ↗
• MalfunctionNov 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE RUBY COIL PUSHER WIRE WAS STUCK INSIDE THE HANDLE. HOWEVER, THE PHYSICIAN WAS ABLE TO MANUALLY DETACH THE RUBY COIL AND SUCCESSFULLY IMPLANT IT INTO THE TARGET LOCATION. AT THIS POINT, THE PROCEDURE WAS FINISHED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863019 ↗
• MalfunctionMay 18, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTA USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN DETERMINED THE RUBY COIL WAS TOO LARGE. THEREFORE, THE RUBY COIL WAS REMOVED AND SAVED FOR LATER USE. LATER IN THE PROCEDURE, WHILE ATTEMPTING TO RE-ADVANCE THE PREVIOUSLY REMOVED RUBY COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, THE RUBY COIL DETACHED FROM ITS PUSHER ASSEMBLY WITHIN ITS INTRODUCER SHEATH PRIOR TO ENTERING THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. 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 11841960 ↗
• MalfunctionMay 3, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING AND ATTEMPTING TO MANIPULATE TWO RUBY COILS, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MICROCATHETER, AND THE PUSHER ASSEMBLIES OF THE RUBY COILS BECAME KINKED. THEREFORE, THE RUBY COILS WERE REMOVED, AND THE MICROCATHETER WAS REPOSITIONED. THE PROCEDURE WAS COMPLETED USING TWELVE 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 11761675 ↗
• MalfunctionApr 19, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND GUIDEWIRE. IT WAS REPORTED THE PATIENT¿S ANATOMY WAS HIGHLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED SEVEN RUBY COILS IN THE TARGET LOCATION. WHEN THE NEXT RUBY COIL WAS RETRACTED FROM THE ANEURYSM FOR REFORMING, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. THE PHYSICIAN THEN RETRIEVED THE DETACHED RUBY COIL AND LANTERN. SUBSEQUENTLY, THE PHYSICIAN REINSERTED THE SAME LANTERN. WHEN ADVANCING THE LANTERN ALONG THE GUIDEWIRE, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE LANTERN WAS RETRIEVED AGAIN. THE PHYSICIAN RESUMED THE PROCEDURE WITH A NEW LANTERN. NO ADDITIONAL COILS WERE IMPLANTED. IT WAS DETERMINED THE EMBOLIZATION HAD BEEN COMPLETED WHEN THE CONFIRMATION CONTRAST WAS PERFORMED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11689110 ↗
• MalfunctionFeb 18, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK OF THE AORTIC ANEURYSM GRAFT USING RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACES MULTIPLE RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING ANOTHER RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN DECIDED TO EXCHANGE TO A NEW 90-DEGREE ANGLE TIP LANTERN. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND A NEW LANTERN. IT SHOULD BE NOTED THAT THERE WAS NO ALLEGED DEFICIENCY OR DAMAGE TO THE FIRST 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 11345117 ↗
• MalfunctionJan 11, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY VEIN USING RUBY COILS, RUBY COIL DETACHMENT HANDLE (HANDLE), AND LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED FOUR RUBY COILS IN THE TARGET VESSEL USING THE HANDLE. WHILE DETACHING THE NEXT FOUR RUBY COILS, THE PHYSICIAN EXPERIENCED DIFFICULTY DETACHING THE FOUR RUBY COILS USING THE HANDLE. IT WAS ALSO REPORTED THAT HANDLE WAS CLICKED MORE THAN ONCE TO DETACH THE FOUR RUBY COILS. SUBSEQUENTLY, THE PHYSICIAN ADVANCED THE NINTH RUBY COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS TO CLICK THE SLIDER ON THE HANDLE. THEREFORE, THE RUBY COIL AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND NEW RUBY COIL. 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 11149990 ↗
• MalfunctionNov 9, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE INSERTING A RUBY COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV), THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED AND, THEREFORE, IT WAS REMOVED. 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 10809166 ↗
• MalfunctionOct 16, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, POD PACKING COILS (POD PCS), POD COILS, RUBY COIL DETACHMENT HANDLES (HANDLES) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED FIVE RUBY COILS, TWO POD PCS, AND TWO POD COILS INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH THEM USING TWO DIFFERENT HANDLES; HOWEVER, THE RUBY COILS, POD PCS AND POD COILS FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE FIVE RUBY COILS, TWO POD PCS AND TWO POD COILS. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

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

  MAUDE report 10690851 ↗
• MalfunctionOct 16, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, POD PACKING COILS (POD PCS), POD COILS, RUBY COIL DETACHMENT HANDLES (HANDLES) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED FIVE RUBY COILS, TWO POD PCS, AND TWO POD COILS INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH THEM USING TWO DIFFERENT HANDLES; HOWEVER, THE RUBY COILS, POD PCS AND POD COILS FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE FIVE RUBY COILS, TWO POD PCS AND TWO POD COILS. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

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

  MAUDE report 10690801 ↗
• MalfunctionOct 16, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, POD PACKING COILS (POD PCS), POD COILS, RUBY COIL DETACHMENT HANDLES (HANDLES) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED FIVE RUBY COILS, TWO POD PCS, AND TWO POD COILS INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH THEM USING TWO DIFFERENT HANDLES; HOWEVER, THE RUBY COILS, POD PCS AND POD COILS FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE FIVE RUBY COILS, TWO POD PCS AND TWO POD COILS. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

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

  MAUDE report 10690767 ↗
• MalfunctionJan 15, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HEPATIC ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN, THEN USED THE HANDLE TO DETACH THE RUBY COIL; HOWEVER, THE RUBY COIL FAILED TO DETACH. THE PHYSICIAN REPORTED THAT THE RUBY COIL WOULD NOT DETACH AFTER SEVERAL ATTEMPTS. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE, THE SAME 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 9592340 ↗
• MalfunctionMar 21, 2019Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN LOST POSITIONING AND, THEREFORE, RE-SHEATHED THE RUBY COIL. THE PHYSICIAN THEN RE-ATTEMPTED TO PLACE THE FIRST PART OF THE RUBY COIL IN THE VENOUS OUTFLOW WHICH WAS SMALLER THAN THE ANEURYSM SAC; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE SHAPE OF THE FIRST LOOP. THEREFORE, THE PHYSICIAN RETRACTED THE RUBY COIL BACK INTO ITS INTRODUCER SHEATH AND SAVED IT FOR LATER USE. THE PHYSICIAN THEN PLACED A POD8 AND RE-ATTEMPTED TO USE THE SAME RUBY COIL; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE FROM ITS INITIAL POSITION INSIDE OF THE INTRODUCER SHEATH AND ITS PUSHER ASSEMBLY WAS FOUND TO BE KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE RUBY COIL MAY HAVE GOTTEN CLOTTED WHEN RE-SHEATHING; HOWEVER, THE RUBY COIL WAS RINSED WITH SALINE PRIOR TO REUSE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND ADDITIONAL COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8440660 ↗
• MalfunctionJan 31, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA CATHETER WITHIN THE PATIENT AND THEN ATTEMPTED TO ADVANCE THE LANTERN OUT OF THE TIP OF THE CATHETER USING A GUIDEWIRE. HOWEVER, THE PHYSICIAN REPORTED THAT THE LANTERN FELT ¿STICKY¿ AND WAS UNABLE TO ADVANCE MORE THAN 3 CM OUTSIDE THE TIP OF THE CATHETER. THEREFORE, THE LANTERN WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE A VELOCITY USING THE CATHETER, HOWEVER, THE VELOCITY ALSO FELT ¿STICKY¿ AND WAS UNABLE TO ADVANCE MORE THAN 3 CM OUTSIDE THE TIP OF THE CATHETER. THEREFORE, THE VELOCITY WAS REMOVED. THE PHYSICIAN THEN WAS ABLE TO PLACE A NON-PENUMBRA MICROCATHETER IN THE TARGET ANEURYSM, DESPITE EXPERIENCING EXTREME DIFFICULTY ADVANCING. HOWEVER, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL MORE THAN 30 CM WITHIN THE MICROCATHETER. THE PHYSICIAN NOTICED THE MICROCATHETER WAS "ACCORDIONED" WHERE IT ENTERED THE CATHETER AND THEREFORE ATTEMPTED TO STRAIGHTEN OUT THE SYSTEM. HOWEVER, THE PHYSICIAN WAS STILL UN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8294348 ↗