RUBY Coil RBY2C0512-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI M424RBY2C05120), received between Sep 11, 2015 and Jan 24, 2022 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Kinked” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT RUBY COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE BUT, THE PHYSICIAN CONTINUED TO ADVANCE THE RUBY COIL FURTHER INTO THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN CONTINUED TO EXPERIENCE RESISTANCE. WHILE MOVING THE PUSHER ASSEMBLY OF THE RUBY COIL, THE PHYSICIAN NOTICED THAT THE RUBY COIL DID NOT RESPOND. SUBSEQUENTLY, IT WAS NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN SUCCESSFULLY FLUSHED THE DETACHED RUBY COIL INTO THE TARGET VESSEL USING A SYRINGE. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13339099 ↗
• MalfunctionOct 5, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN WAS UNABLE ADVANCE A RUBY COIL OUT OF THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ATTEMPTING TO INSERT A NEW RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED; THEREFORE, THE RUBY COIL WAS REMOVED. THEN, WHILE ATTEMPTING TO PLACE A NEW RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN DETERMINED THAT THE COIL WAS TOO SMALL; THEREFORE, THE RUBY COIL WAS REMOVED INTACT. 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; No Consequences Or Impact To Patient

  MAUDE report 10628448 ↗
• MalfunctionMar 28, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING PREPARATION FOR THE PROCEDURE, THE HOSPITAL STAFF NOTICED THE PUSHER ASSEMBLY OF A RUBY COIL WAS BENT UPON REMOVAL FROM ITS PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL WAS NOTICED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL OUT OF THE TIP OF THE MICROCATHETER AND INTO THE PATIENT'S HEPATIC ARTERY; AND CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED COIL, AND THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8461314 ↗
• MalfunctionMar 8, 2019Failure to Fold; Separation Problem; Failure to Fold; Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ARTERY BLEED USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A RUBY COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN NOTICED THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE AND THEREFORE THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. HOWEVER, UPON REMOVAL, THE RUBY COIL DETACHED OUTSIDE OF THE PATIENT¿S BODY. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL INTO THE TARGET VESSEL; HOWEVER, THE RUBY COIL WAS OVERSIZED, AND THE PHYSICIAN DECIDED TO RETRACT IT. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED AND BECAME STUCK INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405261 ↗
• MalfunctionJun 29, 2018Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE NON-PENUMBRA MICROCATHETER AND, CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED. THE RUBY COIL WAS, THEREFORE, REMOVED, AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, POD COILS, POD PACKING 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 7651580 ↗
• MalfunctionJun 20, 2018Detachment Of Device Component; Positioning Problem; Detachment Of Device Component; Positioning Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO RETRACT A RUBY COIL FROM A NON-PENUMBRA MICROCATHETER FOR REPOSITIONING, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL AND FLUSHED THE COIL OUT. 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 7620477 ↗
• MalfunctionJun 15, 2018Kinked; Device Damaged Prior to Use; Device Handling Problem; Kinked; Device Damaged Prior to Use; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE SCRUB TECHNOLOGIST ACCIDENTALLY KINKED THE RUBY COIL UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7606346 ↗
• MalfunctionDec 18, 2017Delivered as Unsterile Product; Unsealed Device Packaging; Out-Of-Box Failure; Delivered as Unsterile Product; Unsealed Device Packaging; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, IT WAS NOTICED THAT THE TOP OF THE STERILE POUCH CONTAINING A NEW RUBY COIL WAS NOT SEALED UPON OPENING THE PACKAGING BOX. THE UNSEALED STERILE PACKAGE WAS FOUND PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING OTHER RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 7124534 ↗
• MalfunctionNov 10, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE HUB OF THE MICROCATHETER AND THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN DID NOT USE AN RHV AND DID NOT MAINTAIN CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7020052 ↗
• MalfunctionDec 30, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED, STILL INSIDE ITS INTRODUCER SHEATH AND THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND THE SAME 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 THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6215621 ↗
• MalfunctionJun 17, 2016Detachment Of Device Component; Retraction Problem; Activation, Positioning or Separation Problem; Detachment Of Device Component; Retraction Problem; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) FOR A GASTROINTESTINAL BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A RUBY COIL INTO THE TARGET VESSEL USING ANOTHER MANUFACTURER'S MICROCATHETER BUT DID NOT LIKE THE WAY THE COIL DEPLOYED IN THE VESSEL AND DECIDED TO RESHEATH THE COIL. WHILE THE RUBY COIL WAS BEING RETRACTED BACK INTO ITS INTRODUCER SHEATH, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE DETACHED RUBY COIL WAS 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 5732814 ↗
• MalfunctionMar 28, 2016Kinked; Device Handling Problem; Kinked; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN INADVERTENTLY KINKED THE RUBY COIL PUSHER ASSEMBLY UPON REMOVAL FROM THE PACKAGING. THE RUBY COIL PUSHER ASSEMBLY WAS KINKED PRIOR TO USE. THEREFORE, THE RUBY COIL WAS NOT USED FOR THE PROCEDURE AND A NEW RUBY COIL WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 5529494 ↗
• InjurySep 17, 2015Migration or Expulsion of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND ANOTHER MANUFACTURER'S MICROCATHETER. WHILE DEPLOYING THE RUBY COIL IN THE ANEURYSM, THE PHYSICIAN MET RESISTANCE AND DECIDED TO REMOVE IT. UNDER FLUOROSCOPY, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED. A SNARE DEVICE WAS SUCCESSFULLY USED TO REMOVE THE COIL FROM THE PATIENT WITHOUT ANY ISSUES. THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A SECOND RUBY COIL IN THE ANEURYSM. HOWEVER, WHILE WITHDRAWING THE MICROCATHETER, A PORTION OF THE RUBY COIL MIGRATED INTO THE GDA. THE PHYSICIAN REQUIRED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE RUBY COIL. THE PHYSICIAN CHOSE TO END THE PROCEDURE AND THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5084968 ↗
• MalfunctionSep 11, 2015Device-Device Incompatibility

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH ANOTHER MANUFACTURER'S DIAGNOSTIC CATHETER AND IT WAS REMOVED. WHILE ADVANCING A NEW RUBY COIL THROUGH THE DIAGNOSTIC CATHETER THE PHYSICIAN MET RESISTANCE AGAIN AND REMOVED THE RUBY COIL. THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S SYSTEM. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5072253 ↗