RUBY Coil RBY2C0840-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00814548018867), received between Oct 30, 2018 and Feb 21, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE RUBY COIL IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN CONTINUED TO ADVANCE THE RUBY COIL AND THE PUSHER ASSEMBLY BECAME KINKED AND FRACTURED. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439936 ↗
• MalfunctionJan 3, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, THE SAME LANTERN, AND SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088108 ↗
• MalfunctionNov 1, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) ANEURYSM USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL AS THE FIRST COIL INTO THE ANEURYSM; HOWEVER, THE COIL WOULD NOT ANCHOR. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL TO REPOSITION THE LANTERN. SUBSEQUENTLY, UPON ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN NOTICED THE COIL WOULD NOT PULL BACK AND, THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THE PHYSICIAN THEN USED A SYRINGE TO PULL NEGATIVE PRESSURE ON THE LANTERN AND THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED TOGETHER AS A UNIT. IT WAS REPORTED THAT MORE THAN HALF OF THE DETACHED RUBY COIL WAS STILL INSIDE THE LANTERN AND UPON FLUSHING THE LANTERN ON THE BACK TABLE, THE PHYSICIAN NOTICED THE RUBY COIL HAD UNRAVELED AND WAS NOT INTACT WITH THE REMAINDER OF THE COIL BEING STUCK INSIDE THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709858 ↗
• MalfunctionMay 26, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, AND A NON-PENUMBRA ANGLED GLIDE CATHETER (4FR 100CM). DURING THE PROCEDURE, THE LANTERN BROKE IN HALF AROUND THE MIDSHAFT TO THE DISTAL END WHILE BEING RETRACTED. IT WAS REPORTED A RUBY COIL WAS STUCK IN THE BROKEN LANTERN. THEREFORE, THE LANTERN WAS REMOVED BY PULLING THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND NEW POD COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891321 ↗
• InjuryDec 4, 2020Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CORONARY FISTULA CONNECTING TO THE MAIN PULMONARY ARTERY USING RUBY COILS, A POD PACKING COIL (POD PC), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS IN THE TARGET LOCATION USING THE LANTERN; HOWEVER, WHILE PLACING THE POD PC, THE TWO RUBY COILS AND POD PC BECAME DISLODGED. CONSEQUENTLY, THE TWO RUBY COILS AND POD PC MIGRATED INTO THE MAIN PULMONARY ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE TWO RUBY COILS AND POD PC. 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 Consequences Or Impact To Patient

  MAUDE report 10946281 ↗
• MalfunctionJul 10, 2020Migration; Premature Separation; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT HAD HIGH FLOW VESSELS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THREE RUBY COILS INDIVIDUALLY TO THE TARGET VESSEL AND ATTEMPTED TO FORM EACH RUBY COIL. HOWEVER, THE RUBY COILS WOULD NOT FORM AND WERE RE-SHEATHED. AFTER BEING RE-SHEATHED, TWO OF THE RUBY COILS WERE UNABLE TO ADVANCE OUT OF THEIR INTRODUCER SHEATHS. THE PHYSICIAN THEN RE-ADVANCED THE THIRD RUBY COIL, AND WHILE PLACING THE RUBY COIL IN THE TARGET VESSEL, THE RUBY COIL FORMED APPROXIMATELY 70% BUT FLOWED BACK ACROSS THE SPLENIC ARTERY AND PAST THE CELIAC TRUNK. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO RE-SHEATH THE RUBY COIL AGAIN; HOWEVER, IT UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE SPLENIC ARTERY. THEREFORE, THE PHYSICIAN FLUSHED THE REMAINING COIL OUT OF THE MICROCATHETER AND INTO THE VESSEL. NO ATTEMPT WAS MADE TO REMOVE THE DETACHED RUBY COIL. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10261131 ↗
• MalfunctionFeb 6, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, APPROXIMATELY THREE-FOURTHS OF THE RUBY COIL WAS ADVANCED INTO THE VESSEL WHEN IT UNINTENTIONALLY DETACHED. SUBSEQUENTLY, THE RUBY COIL WAS FLUSHED INTO THE TARGET VESSEL AND IMPLANTED. 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 Consequences Or Impact To Patient

  MAUDE report 9678738 ↗
• MalfunctionDec 11, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED; THEREFORE, IT WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A POD6 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 9452208 ↗
• MalfunctionMay 24, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, THE PHYSICIAN REPORTED THAT A RUBY COIL BECAME KINKED UPON REMOVAL FROM ITS PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING SIX OTHER RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8641463 ↗
• MalfunctionApr 29, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, IT WAS REPORTED THAT A RUBY COIL PUSHER WIRE BECAME KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND THEREFORE THE COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8562913 ↗
• MalfunctionOct 30, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL, A HOSPITAL STAFF ACCIDENTALLY DROPPED THE RUBY COIL ON THE GROUND, PRIOR TO USE IN THE PATIENT. THE RUBY COIL WAS NO LONGER STERILE, AND WAS THEREFORE DISCARDED AND NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8022189 ↗