RUBY Coil RBY4C0406-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00814548018331), received between Feb 12, 2019 and Dec 21, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH THE RUBY COIL USING THE HANDLE. HOWEVER, THE RUBY COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE FIVE TO SIX ATTEMPTS TO DETACH THE RUBY COIL USING THE HANDLE AND BY MANUALLY DETACHING IT BUT WERE UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN FLUSHED THE DETACHED RUBY COIL INTO THE TARGET LOCATION. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH THE RUBY COIL USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED USING TWO OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373518 ↗
• MalfunctionJul 18, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN INFERIOR MESENTERIC ARTERY (IMA) ENDOLEAK USING RUBY COILS, A POD PACKING COIL (POD PC), A NON-PENUMBRA MICROCATHETER, AND GUIDEWIRE (GLIDEWIRE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT MANUALLY BY BREAKING THE PUSHER ASSEMBLY; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED TWO RUBY COILS TO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE COILS USING THE HANDLE; HOWEVER, IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN MANUALLY DETACHED THE TWO RUBY COILS BY BREAKING THE PUSHER ASSEMBLIES OF THE COILS. IT WAS REPORTED THAT THE RUBY COILS DETACHED PARTIALLY IN THE MICROCATHETER; THEREFORE, THE PHYSICIAN PUSHED THE COILS OUT OF THE MICROCATHETER AND INTO THE TARGET LOCATION USING THE GUIDEWIRE. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE GUIDEWIRE TO PUSH THE DETACHED RUBY COILS INTO THE TARGET LOCATION. THEN, THE PHYSICIAN ADVANCED THE POD PC TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, IT WAS ALSO UNSUCCESSFUL. SUBSEQUENTLY, THE PHYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047960 ↗
• MalfunctionSep 28, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS, POD PACKING COILS (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF THE RUBY COIL AND THE PUSHER ASSEMBLY OF THE POD PC KINKED WHILE ADVANCING THE COILS THROUGH THEIR INTRODUCER SHEATHS. THEREFORE, THE RUBY COIL AND THE POD PC WERE REMOVED. IT WAS REPORTED THAT BOTH THE COILS WERE ABLE TO ADVANCE PAST THEIR INITIAL POSITION. THE PROCEDURE WAS COMPLETED USING TWO RUBY COILS, ONE POD PC AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543614 ↗
• MalfunctionApr 15, 2021Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN AND SUBSEQUENTLY, THE COIL BECAME DETACHED. THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY VISUALIZATION THAT THERE WAS A GAP OR BREAK IN THE RUBY COIL AND THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. THE RUBY COIL WAS THEN REMOVED FROM THE LANTERN AND APPEARED TO BE BROKEN INTO TWO PIECES. 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

  MAUDE report 11674862 ↗
• MalfunctionMar 11, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT PULMONARY ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE VESSEL USING THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT ANCHOR AGAINST THE VESSEL AND TAKE ITS INTENDED SHAPE THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL INTO THE TARGET LOCATION; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11466943 ↗
• MalfunctionMar 8, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE LAST RUBY COIL INTO THE MICROCATHETER. IT WAS REPORTED THAT THE TECHNICIAN HAD KINKED THE RUBY COIL PUSHER WIRE. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11438625 ↗
• MalfunctionDec 31, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED RUBY COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE ANOTHER RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE RUBY COIL HALFWAY THROUGH THE MICROCATHETER. CONSEQUENTLY, THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME MICROCATHETER. 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 11101662 ↗
• MalfunctionNov 11, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A TOTAL OF SIX RUBY COILS AND NON-PENUMBRA COILS WERE SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION. NEXT, THE TECHNICIAN ADVANCED A RUBY COIL A SHORT DISTANCE INTO THE MICROCATHETER AND COULD NOT ADVANCE IT FURTHER. THEREFORE, THE RUBY COIL WAS REMOVED. THE SAME ISSUE OCCURRED WITH THE NEXT RUBY COIL. THEREFORE, THIS RUBY COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND NON-PENUMBRA COILS. 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 10826344 ↗
• MalfunctionSep 17, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TOWARDS THE END OF THE PROCESS OF ADVANCING THE RUBY COIL THROUGH THE LANTERN, RESISTANCE WAS ENCOUNTERED. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT AND RE-SHEATH THE RUBY COIL, THE PUSHER ASSEMBLY CAME OUT WITHOUT THE COIL. SUBSEQUENTLY, THE PHYSICIAN NOTICED THE RUBY COIL WAS DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL WITH 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 10551019 ↗
• MalfunctionMay 28, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE RIGHT GASTRIC ARTERY USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED WHILE ADVANCING THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 10098946 ↗
• MalfunctionNov 19, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL, THE RUBY COIL DETACHED INSIDE THE MICROCATHETER; THEREFORE, THE PHYSICIAN PULLED THE DETACHED RUBY COIL OUT OF THE MICROCATHETER TO REMOVE IT. THE PROCEDURE WAS COMPLETED USING TWO 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 9344832 ↗
• MalfunctionOct 9, 2019Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE RUBY COIL DETACHED PARTIALLY IN THE INTRODUCER SHEATH AND PARTIALLY INTO THE LANTERN; THEREFORE, THE HOSPITAL TECHNOLOGIST PULLED THE RUBY COIL OUT FROM THE LANTERN. THE HOSPITAL TECHNOLOGIST THEN ATTEMPTED TO ADVANCE ANOTHER TWO RUBY COILS; HOWEVER, THEY DETACHED PARTIALLY IN THE INTRODUCER SHEATH AND PARTIALLY INTO THE LANTERN. THEREFORE, THE HOSPITAL TECHNOLOGIST PULLED THE TWO RUBY COILS OUT FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS 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 9173504 ↗
• MalfunctionMay 3, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROEPIPLOIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A 4X6 RUBY COIL THROUGH THE NON-PENUMBRA MICROCATHETER AND REPORTED THAT THE COIL PUSHER WIRE SUBSEQUENTLY BECAME KINKED. THE 4X6 RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. IT WAS ALSO REPORTED THAT RESISTANCE WAS EXPERIENCED WHILE ADVANCING THE NEXT COIL, A 3X5 RUBY COIL, THROUGH THE PROXIMAL PART OF THE SAME MICROCATHETER. THE PHYSICIAN THEN DECIDED NOT TO ADVANCE THE 3X5 RUBY COIL ANY FURTHER THROUGH THE MICROCATHETER AND, THEREFORE, THE 3X5 RUBY COIL WAS REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577486 ↗
• 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 8508988 ↗
• MalfunctionFeb 12, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH TORTUOUS ANATOMY INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND USED A HANDLE TO DETACH IT; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED RUBY COIL. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT RUBY COIL AND; THEREFORE, THE PHYSICIAN MANUALLY DETACHED IT. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL RUBY COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8333881 ↗