RUBY Coil RBY2C3260-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00814548019321), received between Nov 6, 2018 and May 27, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN SPLENIC ARTERY USING A RUBY COIL, A NON-PENUMBRA DIAGNOSTIC CATHETER AND A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THAT THE RUBY COIL WOULD NOT ADVANCE. THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE DIAGNOSTIC CATHETER AND THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING SEVEN ADDITIONAL RUBY COILS, ANOTHER MICROCATHETER, AND ANOTHER DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306918 ↗
• MalfunctionNov 22, 2023Migration; Premature Separation; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) TO THE MARGINAL ARTERY OF THE INFERIOR MESENTERIC ARTERY (IMA) USING A RUBY COIL, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER, THE MICROCATHETER WOULD KICK BACK. IT WAS REPORTED THAT SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE RUBY COIL; HOWEVER, THE MICROCATHETER WOULD KICK BACK EACH ATTEMPT. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE SMA TO THE MARGINAL ARTERY OF THE IMA. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM AND THE PHYSICIAN SURGICALLY REMOVED THE RUBY COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18195371 ↗
• MalfunctionOct 16, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK VIA TRANSCAVAL APPROACH USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE LANTERN WOULD KICK BACK OUT FROM THE TARGET LOCATION. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL TO BE RESHEATHED. SUBSEQUENTLY, WHILE ATTEMPTING TO RETRACT THE RUBY COIL BACK INTO THE INTRODUCER SHEATH, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT FROM 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 17941306 ↗
• MalfunctionMay 30, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GONADAL VEIN USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RUBY COIL THROUGH THE DISTAL END OF THE PX SLIM. THEREFORE, THE RUBY COIL AND THE PX SLIM WERE REMOVED. AFTER REMOVING THE PX SLIM, THE PHYSICIAN NOTICED THAT IT WAS BENT AT THE DISTAL END AND THE RUBY COIL WAS UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019832 ↗
• MalfunctionOct 22, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL; 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12682820 ↗
• 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 11761677 ↗
• MalfunctionMar 19, 2021Failure 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 POD PACKING COIL (POD PC), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COILS AND A POD PC WERE RE-SHEATHED AND SAVED FOR LATER USE, AS INITIALLY THE TWO RUBY COILS AND THE POD PC WERE TOO LONG FOR THE BRANCH VESSEL. LATER, WHILE ATTEMPTING TO USE THE TWO PREVIOUSLY REMOVED RUBY COILS, THE PHYSICIAN NOTICED THAT THE TWO RUBY COILS WERE STUCK WITHIN ITS INTRODUCER SHEATHS AND WOULD NOT ADVANCE AT ALL. THEREFORE, THE TWO RUBY COILS WERE REMOVED. SUBSEQUENTLY, WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE THE PREVIOUSLY REMOVED POD PC WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE POD PC. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 11532279 ↗
• MalfunctionDec 13, 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). DURING THE PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PUSHER ASSEMBLIES OF TWO RUBY COILS WERE BENT UPON REMOVAL FROM PACKAGING ON THE BACK TABLE. THE DAMAGE TO THE RUBY COILS WERE FOUND PRIOR TO USE AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. WHILE INSERTING A RUBY COIL INTO THE LANTERN, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL DETACHED FROM ITS PUSHER ASSEMBLY OUTSIDE OF THE PATIENT. THEREFORE, THE TECHNICIAN PULLED OUT THE DETACHED RUBY COIL USING THEIR FINGERS WITHOUT HAVING TO REMOVE THE LANTERN. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10997361 ↗
• 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 10690649 ↗
• 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 10690632 ↗
• MalfunctionFeb 7, 2020Failure 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 LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIAL RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL THROUGH ITS INTRODUCER SHEATH AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9682668 ↗
• MalfunctionNov 18, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD10S AND A RUBY COIL DETACHMENT HANDLE (HANDLE). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS EXTREMELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO RUBY COILS IN THE TARGET VESSEL USING THE HANDLE. WHILE ATTEMPTING TO DETACH THE NEXT RUBY COIL IN THE TARGET VESSEL, THE HANDLE FAILED TO DETACH THE RUBY COIL; THEREFORE, THE PHYSICIAN MANUALLY DETACHED IT. THE SAME ISSUE OCCURRED FOR THE FOLLOWING RUBY COIL AND POD10; THE HANDLE FAILED TO DETACH RUBY COIL AND POD10; THEREFORE, THE PHYSICIAN MANUALLY DETACHED THEM. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9339151 ↗
• MalfunctionMay 30, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL PUSHER ASSEMBLY APPEARED TO HAVE BEEN KINKED WHILE BEING REMOVED FROM ITS DISPENSER HOOP. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8656565 ↗
• MalfunctionMay 29, 2019Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL WAS INADVERTENTLY BENT WHEN REMOVED FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8651476 ↗
• MalfunctionApr 25, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE RUBY COIL PUSHER WIRE BECAME KINKED DURING ADVANCEMENT INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN). THE RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. 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 8552393 ↗
• MalfunctionFeb 6, 2019Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE NATIVE ILIAC WALL USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO INSERT A NEW RUBY COIL INTO THE LANTERN, THE PUSHER WIRE SNAPPED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313432 ↗
• MalfunctionNov 6, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN AORTIC ANEURYSM SACK USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET VESSEL. WHILE ATTEMPTING TO REPOSITION A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN NOTICED THAT THE RUBY COIL DID NOT RETRACT WITH ITS PUSHER ASSEMBLY, INDICATING THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED. SINCE MOST OF THE DETACHED RUBY COIL WAS IN THE LANTERN, THE PHYSICIAN ATTEMPTED TO FLUSH OUT THE DETACHED RUBY COIL FROM THE LANTERN; HOWEVER, IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN USED A WIRE AND PUSHED THE DETACHED RUBY COIL; HOWEVER, THE LANTERN BECAME REPOSITIONED IN THE INFERIOR MESENTERIC ARTERY (IMA) AND THE DETACHED RUBY COIL WAS DEPLOYED IN THE IMA WHICH ELIMINATED ACCESS TO THE AORTIC ANEURYSM SACK. THE PHYSICIAN DID NOT MAKE AN ATTEMPT TO REMOVE THE DETACHED COIL SINCE THE IMA WAS GOING TO BE EMBOLIZED AS WELL. THE PROCEDURE WAS COMPLETED AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8044704 ↗