RUBY Coil RBY2C1240-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814548019086), received between Oct 4, 2018 and Jun 3, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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.

• MalfunctionJun 3, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A VARICOCELE USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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

  MAUDE report 22136049 ↗
• MalfunctionSep 19, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. AFTER THREE FAILED ATTEMPTS, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088321 ↗
• MalfunctionMay 22, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND POD PACKING COILS (POD PCS). DURING THE PROCEDURE, THE PHYSICIAN REPORTED EXPERIENCING SOME RESISTANCE WHILE RE-POSITIONING A RUBY COIL AND THAT IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN DELIVERY MICROCATHETER (LANTERN). THE LANTERN AND THE RUBY COIL WERE RETRACTED FROM THE PATIENT AND THE RUBY COIL WAS SUCCESSFULLY REMOVED FROM THE LANTERN. THE PHYSICIAN CONTINUED THE PROCEDURE AND DETACHED A POD PC INTO THE TARGET VESSEL USING THE SAME LANTERN. SUBSEQUENTLY, IT WAS REPORTED THAT THE POD PC HAD MIGRATED OUT OF THE TARGET VESSEL INTO THE PATIENT'S ANATOMY. THE PHYSICIAN RETRIEVED THE POD PC USING A SNARE, AND THE POD PC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8634170 ↗
• MalfunctionMay 2, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE THE RUBY COILS AGAIN; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS THEN COMPLETED WITH TWO SHORTER NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575421 ↗
• MalfunctionMay 2, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY AND THE AORTA USING POD5S AND RUBY COILS. DURING THE PROCEDURE, THE FELLOW ACCIDENTALLY DROPPED A POD5 ON THE FLOOR WHILE REMOVING IT FROM THE PACKAGING HOOP. THE POD5 WAS DROPPED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS THEN CONTINUED USING A NEW POD5. THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE FELLOW THEN ACCIDENTALLY KINKED A RUBY COIL (F83494) WHILE REMOVING IT FROM THE PACKAGING HOOP. THE PHYSICIAN STILL ATTEMPTED TO ADVANCE THE RUBY COIL THROUGH THE LANTERN, HOWEVER, WAS UNABLE TO. THEREFORE, THE RUBY COIL WAS REMOVED, AND A NEW RUBY COIL WAS SUCCESSFULLY PLACED. THROUGHOUT THE REMAINDER OF THE PROCEDURE, THREE MORE RUBY COILS WERE INADVERTENTLY KINKED UPON REMOVAL FROM THEIR PACKAGING HOOPS AND, THEREFORE, NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8575060 ↗
• MalfunctionNov 7, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK IN THE ILIOLUMBAR ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THE INITIAL RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA SHEATH. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE SHEATH AND DETACHED COIL TOGETHER. THE PROCEDURE WAS ENDED AT THIS POINT AND NO OTHER COIL WAS PLACED. IT SHOULD BE NOTED THAT THERE WAS NO NOTED DAMAGE TO THE LANTERN AFTER REMOVAL. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047585 ↗
• MalfunctionOct 4, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL OUT OF THE TIP OF A LANTERN DELIVERY MICROCATHETER (LANTERN) AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN, THEREFORE, REMOVED THE LANTERN WITH THE RUBY COIL INSIDE. THE PROCEDURE WAS 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 7936830 ↗