RUBY Coil RBY2C0435-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814548018614), received between Dec 11, 2018 and Apr 7, 2022 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN KINKED THE RUBY COIL AND THE RUBY COIL HAD UNINTENTIONALLY DETACHED. AFTER PERFORMING AN X-RAY, THE RUBY COIL WAS FOUND INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047909 ↗
• MalfunctionMay 5, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PHRENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATH, AND THE PUSHER ASSEMBLY WAS KINKED IN THE BACK. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SEVERAL NEW PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11779913 ↗
• MalfunctionNov 16, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A THORACIC DUCT EMBOLIZATION PROCEDURE USING RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER AND SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE MICROCATHETER WAS OVALIZED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PHYSICIAN WAS UNABLE TO OBTAIN ACCESS AGAIN DUE TO THE TYPE OF EMBOLIZATION PROCEDURE. THEREFORE, THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT AND PLANNED TO BRING THE PATIENT BACK IN ON A LATER DATE. 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 10848349 ↗
• MalfunctionJun 19, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL, POD DETACHMENT HANDLE (HANDLE) AND, LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE INSERTING A RUBY COIL INTO LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY AND BECAME STUCK AT THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED SEVERAL INJECTIONS OF SALINE WITH A 3CC SYRINGE TO PUSH THE DETACHED RUBY COIL INTO THE VESSEL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176826 ↗
• MalfunctionFeb 21, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILEOCOLIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER (PROGREAT). DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A RUBY COIL IN THE TARGET VESSEL USING THE PROGREAT, THE RUBY COIL REPEATEDLY KICKED BACK THE PROGREAT OUT OF THE TARGET VESSEL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMALLER RUBY COILS AND THE SAME PROGREAT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9737070 ↗
• MalfunctionMar 20, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH THE LANTERN AND, THEREFORE, THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A POD PACKING 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 8437386 ↗
• MalfunctionDec 11, 2018Device Damaged Prior to Use; Device Fell; Device Damaged Prior to Use; Device Fell

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE BACK END OF A RUBY COIL CAME IN CONTACT WITH A NON-STERILE AREA UPON REMOVAL FROM THE DISPENSER HOOP AND BECAME CONTAMINATED. THE RUBY COIL BECAME CONTAMINATED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8151031 ↗