RUBY Coil RBY2C0420-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548018591), received between Mar 1, 2019 and Feb 2, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionFeb 2, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239349 ↗
• MalfunctionDec 1, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RECTAL ARTERIES USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE LANTERN WAS USED TO IMPLANT APPROXIMATELY SIX RUBY COILS INTO THE TARGET LOCATION. WHILE THE NEXT RUBY COIL WAS PARTIALLY ADVANCED INTO THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL PUSHER WIRE BROKE IN HALF. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL 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 10927606 ↗
• MalfunctionOct 9, 2020Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL MAMMARY ARTERY (RIMA) AND LEFT INTERNAL MAMMARY ARTERY (LIMA) USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH ITS INTRODUCER SHEATH, THE PUSHER ASSEMBLY BECAME BENT. THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS ALSO REPORTED THAT THE RUBY COIL HAD DETACHED UPON INSPECTION OUTSIDE OF THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING NEW RUBY COIL AND THE SAME MICROCATHETER. 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 10659057 ↗
• MalfunctionJun 25, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE DETACHED COIL INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NEW MICROCATHETER AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8732782 ↗
• MalfunctionMar 1, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A VESSEL SACRIFICE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED INITIAL RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA 4F GUIDE CATHETER. WHILE ATTEMPTING TO PLACE ANOTHER RUBY COIL IN THE TARGET VESSEL, THE RUBY COIL WOULD NOT STAY IN PLACE DUE TO THE HIGH FLOW OF THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE RUBY COIL IN ORDER TO REPOSITION IT; HOWEVER, RESISTANCE WAS ENCOUNTERED AND UPON REMOVAL, IT WAS NOTICED THAT THE RUBY COIL HAD ¿KNOTTED¿ ON ITSELF. THE PHYSICIAN THEN CONTINUED THE PROCEDURE BY PLACING ADDITIONAL RUBY COILS USING THE SAME GUIDE CATHETER. WHILE ATTEMPTING TO PLACE A NEW RUBY COIL IN THE TARGET VESSEL, THE RUBY COIL WOULD NOT STAY IN PLACE DUE TO THE HIGH FLOW OF THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE RUBY COIL IN ORDER TO REPOSITION IT; HOWEVER, RESISTANCE WAS ENCOUNTERED AND UPON REMOVAL, IT WAS NOTICED THAT THE RUBY COIL HAD ALSO ¿KNOTTED¿ ON ITSELF. AFTER THAT, THE PROCEDURE CONTINUED USING ADDITIONAL RUBY COILS. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE GUIDE CATHETER; THER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8382177 ↗