RUBY Coil RBY2C1440-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M424RBY2C14400), received between May 3, 2016 and Aug 20, 2020 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK AFTER AN ENDOVASCULAR AORTIC REPAIR (EVAR) STENT IMPLANTATION USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE RUBY COIL AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, A NEW HANDLE, 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 10434964 ↗
• MalfunctionNov 12, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN THE MICROCATHETER AND, THEREFORE, THE RUBY COIL WAS RETRACTED. WHILE BEING RETRACTED, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8062736 ↗
• MalfunctionJun 7, 2018Detachment Of Device Component; Out-Of-Box Failure; Detachment Of Device Component; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ANEURYSM USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS NOT ADVANCING INTO THE MICROCATHETER; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT SAME ISSUE OCCURRED WITH FOUR OTHER RUBY COILS. UPON TURNING ON THE LIGHTS IN THE OPERATING ROOM, IT WAS NOTICED THAT THE EMBOLIZATION COILS WERE ON THE GROUND. IT WAS CONCLUDED THAT THE FIVE RUBY COILS, UNKNOWINGLY AT THE TIME, HAD DETACHED UPON REMOVAL FROM THE PACKAGING HOOPS PRIOR TO THE ATTEMPTS MADE TO ADVANCE THEM INTO THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL IN THE TARGET VESSEL AND USED A HANDLE TO SUCCESSFULLY DETACH IT; HOWEVER, IT WAS REPORTED THAT THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK IN THE HANDLE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, ADDITIONAL RUBY 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 7580721 ↗
• MalfunctionMay 19, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ADVANCING AND RETRACTING A RUBY COIL THROUGH THE PX SLIM, THE COIL UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE DETACHED RUBY COIL WAS FLUSHED OUT OF THE PX SLIM WITH SALINE. WHILE ATTEMPTING TO ADVANCE A SECOND RUBY COIL THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND THE COIL WOULD NOT ADVANCE THROUGH THE ENTIRE LENGTH OF THE PX SLIM. THEREFORE, BOTH THE RUBY COIL AND PX SLIM WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW RUBY COILS AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5668492 ↗
• MalfunctionMay 3, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH A PX SLIM; HOWEVER, WHILE REPOSITIONING THE RUBY COIL, IT UNINTENTIONALLY DETACHED. UPON REMOVING THE PX SLIM, THE DETACHED RUBY COIL REMAINED IN THE PATIENT AND WAS REMOVED USING A SNARE DEVICE. WHILE ADVANCING A NEW RUBY COIL THROUGH A NEW PX SLIM, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PX SLIM AND DETACHED RUBY COIL WERE BOTH REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5626338 ↗
• InjuryMay 3, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH A PX SLIM; HOWEVER, WHILE REPOSITIONING THE RUBY COIL, IT UNINTENTIONALLY DETACHED. UPON REMOVING THE PX SLIM, THE DETACHED RUBY COIL REMAINED IN THE PATIENT AND WAS REMOVED USING A SNARE DEVICE. WHILE ADVANCING A NEW RUBY COIL THROUGH A NEW PX SLIM, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PX SLIM AND DETACHED RUBY COIL WERE BOTH REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5626225 ↗