RUBY Coil RBY4C1650-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548018904), received between Aug 22, 2019 and Mar 24, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2023Break; Separation Failure; Break; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT VARICES OFF THE RENAL VEIN USING RUBY COILS, RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED A RUBY COIL IN THE TARGET LOCATION USING THE HANDLE. NEXT, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL INTO THE VESSEL AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING A HANDLE AND HEMOSTATS; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. SUBSEQUENTLY, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN NOTICED THE DISTAL END OF THE RUBY COIL PUSHER ASSEMBLY BROKE INSIDE THE MICROCATHETER. IT WAS REPORTED THE RUBY COIL WAS ALREADY IN THE TARGET LOCATION AND WAS INTERTWINED WITH THE PREVIOUSLY PLACED RUBY COIL. THEREFORE, WHEN THE PHYSICIAN WAS REMOVING THE MICROCATHETER CONTAINING THE BROKEN PUSHER ASSEMBLY WITH THE RUBY COIL, THE PREVIOUSLY PLACED COIL WAS ALSO REMOVED ALONG WITH THE RUBY COIL. THE PROCEDURE WAS THEN COMPLETED USING NEW RUBY COILS, SAME HANDLE, AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615962 ↗
• InjuryNov 17, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIAC VEIN USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL. HOWEVER, WHILE ATTEMPTING TO RETRACT AND RE-SHEATH THE RUBY COIL, IT UNINTENTIONALLY DETACHED IN THE PATIENT¿S BODY. THEREFORE, THE PUSHER ASSEMBLY OF THE RUBY COIL WAS REMOVED FROM THE LANTERN AND THE RUBY COIL WAS SNARED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 10857164 ↗
• MalfunctionAug 22, 2019Failure to Fold; Failure to Advance; Failure to Fold; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WAS ADVANCED INTO THE TARGET AREA USING A LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THAT THE COIL WAS TAKING SHAPE IN THE ANEURYSM. THE PHYSICIAN THEN RE-SHEATHED THE RUBY COIL AND ATTEMPTED TO RE-ADVANCE IT INTO A BOWL OF SALINE; HOWEVER, THE RUBY COIL WOULD NO LONGER ADVANCE OUT OF ITS INTRODUCER SHEATH. THE RUBY COIL WAS THEREFORE NO LONGER USED IN THE PROCEDURE. 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 8923442 ↗