RUBY Coil RBY4C2060-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548019123), received between Jan 25, 2019 and Apr 15, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2024Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED NINE RUBY COILS INTO THE TARGET LOCATION. AFTER ADVANCING THE NEXT RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN MADE AN ATTEMPT TO DETACH THE RUBY COIL MANUALLY WITHOUT SUCCESS. THE PHYSICIAN THEN ATTEMPTED TO RE-POSITION THE COIL AND, WHILE INSERTING THE LAST LOOP OF THE RUBY COIL, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE VESSEL. THEREFORE, THE RUBY COIL WAS REMOVED USING A SNARE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THIS POINT AND NO ADDITIONAL COILS WERE REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19106116 ↗
• MalfunctionMay 25, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN AN ENDOLEAK USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH THE LANTERN AND ATTEMPTED TO DETACH THE RUBY COIL WITH THE HANDLE. WHEN THE RUBY COIL WOULD NOT DETACH, THE HOSPITAL TECHNOLOGIST ATTEMPTED TO MANUALLY DETACH THE RUBY COIL BY MOVING THE MANDREL LATERALLY. WITH SIGNIFICANT FORCE, THE RUBY COIL WAS DETACHED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881050 ↗
• MalfunctionFeb 24, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A SHEATH. DURING THE PROCEDURE, THE FIRST RUBY COIL WOULD NOT ADVANCE PAST THE MIDDLE OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, TWO RUBY COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. NEXT, TWO RUBY COILS WOULD NOT ADVANCE PAST THE MIDDLE OF THE LANTERN. THEREFORE, THESE RUBY COILS WERE REMOVED. THE PHYSICIAN DECIDED TO REMOVE THE LANTERN AND, UPON REMOVAL, THE PHYSICIAN NOTICED THE LANTERN WAS KINKED PROXIMAL TO THE HUB. THEREFORE, THE LANTERN WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN USED A NEW LANTERN TO SUCCESSFULLY IMPLANT ONE RUBY COIL. HOWEVER, THE NEXT RUBY COIL WOULD NOT ADVANCE PAST THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, ANOTHER RUBY COIL, AND THE SAME SHEATH. 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 11376173 ↗
• InjuryDec 23, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GONADAL VEIN USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA DIAGNOSTIC CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, SIXTEEN COILS WERE SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION. WHILE ADVANCING A RUBY COIL INTO THE TARGET VESSEL, THE DIAGNOSTIC CATHETER AND SHEATH MIGRATED UNBEKNOWNST TO THE PHYSICIAN. SUBSEQUENTLY, THE MICROCATHETER AND RUBY COIL MIGRATED OUT OF THE TARGET VESSEL. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE RUBY COIL AND NAVIGATE THE MICROCATHETER AND DIAGNOSTIC CATHETER BACK TO THE TARGET LOCATION; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED. IN AN ATTEMPT TO REMOVE THE DETACHED RUBY COIL, ALL DEVICES WERE WITHDRAWN; HOWEVER, THE PROXIMAL PART OF THE RUBY COIL REMAINED IN THE INFERIOR VENA CAVA (IVC). THEREFORE, THE PHYSICIAN USED A SNARE TO SUCCESSFULLY REMOVE THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING THE SAME CATHETERS AND ADDITIONAL RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9513329 ↗
• MalfunctionJan 25, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE THORACIC AORTA USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SEVERAL COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL FROM ITS INITIAL POSITION IN THE INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND OTHER COILS 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 8279000 ↗