RUBY Coil RBY2C0415-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI M424RBY2C04150), received between Nov 23, 2015 and Sep 2, 2021 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionSep 2, 2021Failure 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 RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN, THE RUBY COIL BECAME STUCK AT THE ROTATING HEMOSTASIS VALVE (RHV) OF THE LANTERN AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND A NEW LANTERN. IT SHOULD BE NOTED THAT THERE WAS NO ALLEGED DEVICE 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

  MAUDE report 12415061 ↗
• MalfunctionMay 20, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE RUBY COIL WAS UNABLE TO ADVANCE OF ITS ORANGE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN FLUSHED THE LANTERN, HOWEVER THE RUBY COIL WAS STILL UNABLE TO ADVANCE THROUGH THE LANTERN. THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860256 ↗
• MalfunctionFeb 26, 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 ADVANCED A RUBY COIL INTO THE TARGET LOCATION BUT WAS NOT SATISFIED WITH THE POSITION AND DECIDED TO REMOVE THE RUBY COIL. UPON REMOVAL, THE RUBY COIL WAS DAMAGED. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL INTO THE TARGET LOCATION; HOWEVER, WAS NOT SATISFIED WITH THE POSITION AND DECIDED TO REMOVE THE RUBY COIL. UPON REMOVAL, THE RUBY COIL WAS DAMAGED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO FLUSH OR ADVANCE A GUIDEWIRE THROUGH THE LANTERN BECAUSE IT SEEMED LIKE THE LANTERN WAS BLOCKED. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A NEW 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 11388096 ↗
• MalfunctionMay 8, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE DISTAL END OF THE MICROCATHETER, RESISTANCE WAS EXPERIENCED AND THE RUBY COIL WAS NOT ABLE TO BE ADVANCED OUT OF THE MICROCATHETER. THE MICROCATHETER AND RUBY COIL WERE TOGETHER REMOVED FROM THE PATIENT AND THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592649 ↗
• MalfunctionApr 3, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL BACK INTO THE NON-PENUMBRA MICROCATHETER FOR REPOSITIONING; HOWEVER, WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED CONTAINING THE RUBY COIL AND THE COIL WAS SAFELY FLUSHED OUT OF THE MICROCATHETER WITH A SYRINGE. THE PROCEDURE WAS COMPLETED USING NEW NON-PENUMBRA 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 8479138 ↗
• MalfunctionAug 23, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO RE-ADVANCE THE RUBY COIL THROUGH THE MICROCATHETER BUT THE SAME ISSUE OCCURRED; 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 7811519 ↗
• InjuryJun 15, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FOUR RUBY COILS IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL OUT OF THE TIP OF THE MICROCATHETER, AFTER IT WAS MORE THAN HALFWAY INTO THE VESSEL. THEREFORE, THE RUBY COIL WAS RETRACTED. WHILE RETRACTING, THE PHYSICIAN EXPERIENCED MORE RESISTANCE AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED AND UNRAVELED. THE PHYSICIAN WAS UNABLE TO FLUSH THE DETACHED RUBY COIL OUT OF THE MICROCATHETER AND INTO THE TARGET LOCATION AND, THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. THE MICROCATHETER WAS ALSO REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7606218 ↗
• MalfunctionDec 7, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS AND POD PACKING COILS (PODJ''S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE AN INITIAL RUBY COIL AND PODJ THROUGH THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COILS. THEREFORE, THE RUBY COIL AND PODJ WERE REMOVED AND 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 Consequences Or Impact To Patient

  MAUDE report 7097777 ↗
• MalfunctionMar 29, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE COILS. THE PHYSICIAN THEN ATTEMPTED TO PLACE A RUBY COIL AND, AFTER SUCCESSFULLY ADVANCING THE RUBY COIL THROUGH ANOTHER MANUFACTURER¿S MICROCATHETER, THE RUBY COIL WAS UNABLE TO DETACH USING THE HANDLE. HOWEVER, THE PHYSICIAN REPORTED THAT THE DETACHMENT ZONE HAD SEPARATED. THE RUBY COIL THEN DETACHED WITHIN THE MICROCATHETER; THEREFORE, THE MICROCATHETER WAS REMOVED WITH THE RUBY COIL INSIDE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, A NEW 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 6442854 ↗
• MalfunctionMar 16, 2017Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE RUBY COIL SHEATH WAS BROKEN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6410831 ↗
• MalfunctionJan 6, 2017Separation Failure; Physical Resistance; Mechanical Jam; Separation Failure; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AN INITIAL RUBY COIL INTO THE TARGET VESSEL USING ANOTHER MANUFACTURER'S MICROCATHETER WITHOUT RESISTANCE AND THEN ATTEMPTED TO DETACH THE COIL USING A RUBY COIL DETACHMENT HANDLE (HANDLE). HOWEVER, THE RUBY COIL DID NOT RELEASE FROM ITS PUSHER ASSEMBLY AND WAS RETRACTED BACK OUT THROUGH THE MICROCATHETER. THE PHYSICIAN DID NOT BELIEVE THAT THERE WAS AN ISSUE WITH THE HANDLE AND OPENED A SECOND RUBY COIL. WHILE ATTEMPTING TO ADVANCE THE COIL THROUGH THE MICROCATHETER, THE PHYSICIAN MET RESISTANCE AND THE COIL BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SECOND RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NEW NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN A CONTINUOUS FLUSH. HOWEVER, THE MICROCATHETER WAS FLUSHED IN BETWEEN EACH COIL USED DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6231113 ↗
• MalfunctionJan 6, 2017Separation Failure; Physical Resistance; Mechanical Jam; Separation Failure; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AN INITIAL RUBY COIL INTO THE TARGET VESSEL USING ANOTHER MANUFACTURER'S MICROCATHETER WITHOUT RESISTANCE AND THEN ATTEMPTED TO DETACH THE COIL USING A RUBY COIL DETACHMENT HANDLE (HANDLE). HOWEVER, THE RUBY COIL DID NOT RELEASE FROM ITS PUSHER ASSEMBLY AND WAS RETRACTED BACK OUT THROUGH THE MICROCATHETER. THE PHYSICIAN DID NOT BELIEVE THAT THERE WAS AN ISSUE WITH THE HANDLE AND OPENED A SECOND RUBY COIL. WHILE ATTEMPTING TO ADVANCE THE COIL THROUGH THE MICROCATHETER, THE PHYSICIAN MET RESISTANCE AND THE COIL BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SECOND RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NEW NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN A CONTINUOUS FLUSH. HOWEVER, THE MICROCATHETER WAS FLUSHED IN BETWEEN EACH COIL USED DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6231105 ↗
• InjuryNov 8, 2016Detachment Of Device Component; Unraveled Material; Detachment Of Device Component; Unraveled Material

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE TREATING AN ACTIVELY BLEEDING DUODENAL MASS USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY EMBOLIZED THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND NON-PENUMBRA COILS WITH NO INCIDENT. THEREAFTER, THE PHYSICIAN BEGAN EMBOLIZING THE INFERIOR PANCREATICODUODENAL ARTERY (IPDA) BY SUCCESSFULLY IMPLANTING A NON-PENUMBRA COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A RUBY COIL IN THE IPDA; HOWEVER, WHILE ADVANCING THE RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN FELT A LOSS OF RESISTANCE AND NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED. THE PHYSICIAN INITIALLY ATTEMPTED TO DELIVER THE RUBY COIL IN THE TARGET VESSEL BY PUSHING IT OUT OF THE MICROCATHETER WITH THE PUSHER ASSEMBLY; HOWEVER, THE RUBY COIL FLEW INTO THE AORTA DUE TO HIGH BLOOD FLOW. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO RETRIEVE THE RUBY COIL. HOWEVER, UPON REMOVING THE RUBY COIL USING THE SNARE, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNRAVELED AND PART OF IT WAS STILL WITHIN THE PATIENT. WHILE PULLING A STRAND OF THIS UNRAVEL RUBY COIL IN ORDER TO REMOVE IT FROM THE PATIENT, THE S

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6087646 ↗
• MalfunctionOct 17, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE HUB OF THE MICROCATHETER. THE PHYSICIAN DID NOT MENTION EXPERIENCING ANY RESISTANCE WHILE ATTEMPTING TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH. THE RUBY COIL WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT MAINTAIN A CONTINUOUS FLUSH BUT DID FLUSH THE MICROCATHETER IN BETWEEN EACH COIL AND USED A ROTATING HEMOSTASIS VALVE (RHV) DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6035641 ↗
• MalfunctionAug 4, 2016Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE LANTERN THROUGH ANOTHER MANUFACTURER'S SHEATH AND INTO THE PATIENT. WHILE ADVANCING THREE RUBY COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE. SUBSEQUENTLY, ALL THREE RUBY COILS BECAME STUCK AT THE SAME LOCATION AND WERE UNABLE TO ADVANCE OUT OF THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED ALL THREE RUBY COILS AND CONTINUED THE PROCEDURE BY DELIVERING ANOTHER MANUFACTURER'S COILS INTO THE TARGET VESSEL USING THE SAME LANTERN. WHILE THE PHYSICIAN WAS ADVANCING THE LAST NON-PENUMBRA COIL THROUGH THE SAME LANTERN, THE COIL BECAME STUCK IN THE LANTERN. THEREFORE, THE LANTERN AND COIL WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S MICROCATHETER AND COILS. THERE WERE NO OBSERVED DAMAGES TO THE LANTERN AFTER REMOVAL FROM THE PATIENT'S BODY. IN ADDITION, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5846953 ↗
• MalfunctionNov 23, 2015Detachment Of Device Component; Material Too Rigid or Stiff; Failure to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD5 COILS AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY A POD5 COIL INTO THE ANEURYSM; HOWEVER, THE POD5 COIL WOULD NOT COIL UP AND WAS REMOVED AND RESHEATHED. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED A POD4 COIL INTO THE ANEURYSM. ANOTHER ATTEMPT WAS MADE TO DEPLOY THE PREVIOUS POD5 COIL BUT WAS AGAIN UNSUCCESSFUL BECAUSE THE COIL WOULD NOT COIL UP IN THE ANEURYSM AND WAS REMOVED. THE PHYSICIAN THEN DECIDED TO DELIVER A NEW RUBY COIL; HOWEVER, THE RUBY COIL BECAME RIGID AND WAS DIFFICULT TO ADVANCE THROUGH THE PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO REMOVE THE RUBY COIL FROM THE PX SLIM, THE RUBY COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN TRIED USING A LARGE SYRINGE TO ASPIRATE THE RUBY COIL OUT AND ALSO FLUSHED IT WITH SALINE BUT WAS UNABLE TO REMOVE THE COIL. LASTLY, THE PHYSICIAN TRIED USING A WIRE TO PUSH THE RUBY COIL OUT BUT WAS ALSO UNSUCCESSFUL. THE PHYSICIAN THEN REMOVED THE PX SLIM CONTAINING THE RUBY COIL AND CONTINUED THE PROCEDURE USING ANOTHER MANUFACTURER'S COILS AND A NEW MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5243740 ↗