RUBY Coil RBY2C0512-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548018621), received between Dec 12, 2018 and Jun 14, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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.

• MalfunctionJun 14, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A RADIOEMBOLIZATION PROCEDURE (Y90) IN THE RIGHT GRASTRIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO A BRANCH OFF THE HEPATIC ARTERY; HOWEVER, THE RUBY COIL WOULD NOT ANCHOR CORRECTLY DUE TO ITS SIZE. THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN WAS CONCERNED WITH THE SMALL LANDING SITE AND THE COMPLICATIONS THAT WOULD ARISE IF A COIL EXTENDED INTO THE HEPATIC ARTERY; THEREFORE, THE PHYSICIAN WAS COMFORTABLE NOT COILING THE VESSEL. LATER IN THE PROCEDURE, WHILE ATTEMPTING TO PLACE ANOTHER RUBY COIL AT THE TOP OF THE GDA, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL WHILE ADVANCING IT THROUGH THE MICROCATHETER. THEREFORE, THE 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 11995390 ↗
• MalfunctionSep 1, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL MAMMARY ARTERY (RIMA) USING RUBY COILS. DURING THE PROCEDURE, IT WAS REPORTED THAT THE RUBY COIL WAS ONLY ABLE TO ADVANCE A SHORT DISTANCE THROUGH ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10477734 ↗
• MalfunctionJul 17, 2020Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL MAMMARY ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL TO CHECK IT. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNRAVELED. IT WAS REPORTED THAT THE PHYSICIAN TOOK A LITTLE FORCE TO RETRACT BACK THE RUBY COIL. 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 10290907 ↗
• MalfunctionApr 12, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING POD PACKING COILS (POD PCS) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD14 COIL IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A POD PC FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN THEREFORE REMOVED THE POD PC AND WAS ABLE TO SUCCESSFULLY PLACE A NEW POD PC IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE HUB OF THE MICROCATHETER AND REPORTED THAT IT WOULD NOT ADVANCE ANY FURTHER. THE RUBY COIL WAS THEN REMOVED AND WAS NOT USED IN THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PHYSICIAN FELT RESISTANCE WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THIS RUBY COIL WAS ALSO REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. IT WAS NOTED THAT THE PHYSICIAN FLUSHED THE NON-PENUMBRA MICROCATHETER AFTER IMPLANTING EACH COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL POD PCS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8508971 ↗
• MalfunctionDec 12, 2018Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF THE RUBY COIL WAS BENT WHILE ADVANCING THE RUBY COIL INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN). THE RUBY COIL WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME LANTERN MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155728 ↗