RUBY Coil RBY2C0740-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M424RBY2C07400), received between Aug 31, 2015 and Mar 8, 2019 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2019Break; Premature Separation; Break; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A SELF-EXPANDING STENT IN THE LEFT RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED 21 RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER, WHILE RETRACTING TO REPOSITION IT, THE RUBY COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED A SNARE DEVICE TO RETRACT THE RUBY COIL, HOWEVER, THE COIL BROKE WHILE PARTIALLY RETRACTED OUT OF THE HUB OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN WAS ABLE TO PULL THE RUBY COIL OUT OF THE MICROCATHETER, AND 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 8404090 ↗
• MalfunctionAug 23, 2018Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; 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 FELT RESISTANCE AND WAS UNABLE TO ADVANCE TWO RUBY COILS OUT OF THE TIP OF THE LANTERN AND, CONSEQUENTLY, THE PUSHER ASSEMBLIES OF THE RUBY COILS BECAME KINKED. THE PHYSICIAN, THEREFORE, REMOVED THE RUBY COILS AND THE LANTERN AND COMPLETED THE PROCEDURE USING NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7809315 ↗
• MalfunctionAug 23, 2018Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; 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 FELT RESISTANCE AND WAS UNABLE TO ADVANCE TWO RUBY COILS OUT OF THE TIP OF THE LANTERN AND, CONSEQUENTLY, THE PUSHER ASSEMBLIES OF THE RUBY COILS BECAME KINKED. THE PHYSICIAN, THEREFORE, REMOVED THE RUBY COILS AND THE LANTERN AND COMPLETED THE PROCEDURE USING NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7809307 ↗
• MalfunctionJun 18, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE NURSE NOTICED THAT A RUBY COIL EMBOLIZATION COIL WAS OUT OF ITS INTRODUCER SHEATH UPON REMOVAL FROM THE DISPENSER HOOP. THE PHYSICIAN THEN TRIED TO PUSH AND PULL THE RUBY COIL BUT IT WAS NOT SUCCESSFUL. THEREFORE, THE RUBY COIL WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING ANOTHER COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7611867 ↗
• MalfunctionJun 7, 2018Detachment Of Device Component; Out-Of-Box Failure; Detachment Of Device Component; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ANEURYSM USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS NOT ADVANCING INTO THE MICROCATHETER; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT SAME ISSUE OCCURRED WITH FOUR OTHER RUBY COILS. UPON TURNING ON THE LIGHTS IN THE OPERATING ROOM, IT WAS NOTICED THAT THE EMBOLIZATION COILS WERE ON THE GROUND. IT WAS CONCLUDED THAT THE FIVE RUBY COILS, UNKNOWINGLY AT THE TIME, HAD DETACHED UPON REMOVAL FROM THE PACKAGING HOOPS PRIOR TO THE ATTEMPTS MADE TO ADVANCE THEM INTO THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL IN THE TARGET VESSEL AND USED A HANDLE TO SUCCESSFULLY DETACH IT; HOWEVER, IT WAS REPORTED THAT THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK IN THE HANDLE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, 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 7580717 ↗
• MalfunctionSep 27, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SUPERIOR MESENTERIC VEIN USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED THE INITIAL RUBY COILS IN THE TARGET VESSEL USING A LANTERN. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL INTO THE LANTERN, THE PHYSICIAN DID NOT MENTION RESISTANCE; HOWEVER, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT UPON ADVANCEMENT INTO THE LANTERN. THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN IMMEDIATELY EXPERIENCED RESISTANCE UPON ADVANCING THE RUBY COIL OUT THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO WITHDRAW THE RUBY COIL; HOWEVER, THE RUBY COIL WOULD NOT WITHDRAW. THE PHYSICIAN THEN WITHDREW THE LANTERN A COUPLE OF MILLIMETERS AND ATTEMPTED TO ADVANCE THE RUBY COIL; HOWEVER, THE RUBY COIL WOULD NOT MOVE. THE PHYSICIAN THEN DECIDED TO RETRACT THE RUBY COIL; HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE PATIENT¿S BODY. THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL; HOWEVER, THE PHYSICIAN WAS UNABLE TO REMOVE THE RUBY COIL AND THE RUBY COIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6897411 ↗
• MalfunctionApr 6, 2017Bent; Device Damaged Prior to Use; Out-Of-Box Failure; Bent; Device Damaged Prior to Use; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, PRIOR TO USE, THE HOSPITAL STAFF INADVERTENTLY BENT A RUBY COIL PUSHER ASSEMBLY WHILE REMOVING THE RUBY COIL FROM ITS DISPENSER HOOP. CONSEQUENTLY, THE RUBY COIL WOULD NOT ADVANCE INTO THE MICROCATHETER AND THEREFORE, IT WAS SET ASIDE. WHILE ATTEMPTING TO LOAD A NEW RUBY COIL INTO THE MICROCATHETER, THE HOSPITAL STAFF NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY AND THEREFORE, THE RUBY COIL WAS SET ASIDE. 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 6464341 ↗
• MalfunctionJan 14, 2016Use of Device Problem; Human Factors Issue; Use of Device Problem; Human Factors Issue

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL TECHNOLOGIST UNINTENTIONALLY DROPPED THE RUBY COIL WHILE REMOVING IT FROM THE DISPENSER HOOP. THE RUBY COIL WAS DROPPED PRIOR TO USE AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE CONTINUED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 5368702 ↗
• MalfunctionAug 31, 2015Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE FIRST RUBY COIL UNINTENTIONALLY DETACHED AND CAME APART WHILE THE PHYSICIAN WAS TRYING TO REMOVE IT. THE PHYSICIAN SUCCESSFULLY REMOVED THE RUBY COIL USING A SNARE DEVICE. THE PHYSICIAN USED ANOTHER RUBY COIL; HOWEVER, A STRONG RESISTANCE WAS FELT AND THE RUBY COIL WAS REMOVED FROM THE MICROCATHETER. THE PROCEDURE SUCCESSFULLY CONTINUED USING A THIRD RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5043198 ↗