RUBY Coil RBY2C0612-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M424RBY2C06120), received between Dec 16, 2015 and May 8, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 8, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN LOADED A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER AND THE RUBY COIL UNINTENTIONALLY DETACHED; THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL AND REMOVED THE COIL FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND 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 7495002 ↗
• MalfunctionFeb 22, 2018Detachment Of Device Component; Mechanical Jam; Detachment Of Device Component; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT PORTAL HYPERTENSION AND ESOPHAGEAL VARICES USING A RUBY COIL. DURING THE PROCEDURE, FOLLOWING THE PLACEMENT OF THE STENT, A 5F GLIDE CATHETER WAS DELIVERED OVER A GUIDEWIRE AND A NON-PENUMBRA COIL WAS DEPLOYED IN AN ATTEMPT TO EMBOLIZE THE VARICES. THE PHYSICIAN THEN DELIVERED A NON-PENUMBRA MICROCATHETER THROUGH THE GLIDE CATHETER AND ATTEMPTED TO USE A RUBY COIL. WHILE ADVANCING THE COIL THROUGH THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. IN AN ATTEMPT TO REMOVE THE DETACHED COIL, THE PHYSICIAN PULLED THE MICROCATHETER THROUGH THE GLIDE CATHETER AND THE COIL BECAME LODGED IN THE GLIDE CATHETER. NUMEROUS ATTEMPTS WERE MADE TO FLUSH THE COIL OUT THE GLIDE CATHETER AND INTO THE VARICES; HOWEVER, THE COIL WOULD NOT ADVANCE. THE PHYSICIAN THEN DELIVERED A GUIDE WIRE THROUGH THE GLIDE CATHETER AND ATTEMPTED TO PUSH THE COIL OUT OF THE GLIDE CATHETER; HOWEVER, THE COIL WOULD STILL NOT ADVANCE. THEREFORE, THE DIAGNOSTIC CATHETER WAS REMOVED WITH THE COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7290432 ↗
• MalfunctionAug 19, 2016Bent; Device Handling Problem; Bent; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH ANOTHER MANUFACTURER¿S MICROCATHETER, RESISTANCE WAS NOT ENCOUNTERED; HOWEVER, THE TECHNOLOGIST INADVERTENTLY BENT THE RUBY COIL PUSHER ASSEMBLY. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME MICROCATHETER. IT SHOULD BE NOTED THAT A ROTATING HEMOSTASIS VALVE (RHV) AND A FLUSH BAG WERE NOT USED DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5889824 ↗
• MalfunctionFeb 25, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED SEVERAL RUBY COILS INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE THE PHYSICIAN WAS ADVANCING A NEW RUBY COIL THROUGH THE PX SLIM, THE RUBY COIL ADVANCED ABOUT 20 CENTIMETERS THROUGH THE PX SLIM AND THEN STOPPED ADVANCING. THE RUBY COIL WAS REMOVED WITHOUT ANY ISSUES AND THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5462020 ↗
• MalfunctionDec 16, 2015Detachment Of Device Component; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE STAFF NOTICED THAT THE RUBY COIL WAS DETACHED UPON REMOVAL FROM ITS HOOP. THE DETACHED RUBY COIL WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 5304644 ↗