RUBY Coil RBY4C1035-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M424RBY4C10350), received between Jul 29, 2016 and May 2, 2018 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, TWO RUBY COILS WOULD NOT ADVANCE INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 7479838 ↗
• MalfunctionMay 2, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, TWO RUBY COILS WOULD NOT ADVANCE INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 7479826 ↗
• MalfunctionMar 7, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ATTEMPTED TO DEPLOY FOUR OTHER RUBY COILS, HOWEVER WAS UNABLE TO DUE TO THE EXTREME ANGLE OF ACCESS INTO THE ANEURYSM, DESPITE MAKING MULTIPLE ADJUSTMENTS TO THE PLACEMENT OF THE LANTERN. CONSEQUENTLY, THE PHYSICIAN FELT RESISTANCE AND THE RUBY COILS UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN REMOVED THE LANTERN TO PULL OUT EACH OF THE FOUR DETACHED RUBY COILS, AND REINSERTED THE SAME LANTERN. THE PROCEDURE WAS THEN COMPLETED USING THE SAME LANTERN AND ADDITIONAL RUBY COILS AFTER THE ACCESS SHEATH WAS ADJUSTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321466 ↗
• MalfunctionMay 5, 2017Physical Resistance; Device Operates Differently Than Expected; Difficult to Advance; Physical Resistance; Device Operates Differently Than Expected; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PELVIC VEIN USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE; 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 Consequences Or Impact To Patient

  MAUDE report 6549129 ↗
• MalfunctionJul 29, 2016Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE TWO CONSECUTIVE RUBY COILS WERE BEING FORCEFULLY ADVANCED BY THE SCRUB TECHNICIAN THROUGH THE LANTERN, THE PUSHER ASSEMBLIES ON BOTH COILS BECAME KINKED AND THE BOTH COILS WERE UNABLE TO ADVANCE OUT OF THE LANTERN. IT SHOULD BE NOTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING BOTH RUBY COILS. THE PHYSICIAN THEN REMOVED BOTH RUBY COILS AND THE LANTERN. ANOTHER MANUFACTURER'S MICROCATHETER WAS OPENED AND TWO NEW RUBY COILS WERE DEPLOYED AND DETACHED INTO THE PATIENT WITHOUT AN ISSUE. WHILE ADVANCING A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE COIL BECAME STUCK AFTER ADVANCING ABOUT HALF WAY OUT OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE COIL WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED AT THIS POINT SINCE THE PHYSICIAN FELT THAT THE VESSEL WAS SUFFICIENTLY EMBOLIZED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5835264 ↗