RUBY Coil RBY2C0825-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00814548018850), received between Jul 24, 2018 and May 20, 2024 — classified as 8 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING POD COILS, RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE LANTERN, THE HOSPITAL TECH EXPERIENCED RESISTANCE AND KINKED THEN FRACTURED THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE, THE POD COIL WAS REMOVED. IT WAS REPORTED THAT THE POD COIL WAS INTACT AND WAS CONNECTED TO THE FRACTURED PUSHER ASSEMBLY. IT WAS REPORTED THAT A SECOND POD COIL WAS UNABLE TO ADVANCE THROUGH THE LANTERN AND WAS REMOVED. NEXT, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE. IT WAS NOTED THAT A SMALL SECTION OF RUBY COIL WAS OUTSIDE OF THE LANTERN. THE PHYSICIAN THEN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE PUSHER WIRE, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE RUBY COIL WAS NOT MOVING AND THE RUBY COIL HAD FRACTURED. THEREFORE, THE GUIDE CATHETER AND LANTERN CONTAINING THE RUBY COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL RUBY COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353363 ↗
• MalfunctionApr 24, 2023Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING POD PACKING COILS (POD PC), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE POD PCS IN TARGET VESSEL USING THE LANTERN. IT WAS REPORTED THAT AFTER PLACING THE THREE POD PCS, THE PHYSICIAN NOTICED THE DISTAL END AND MIDSHAFT OF THE LANTERN WAS KINKED BY THE COIL COMPACTION. THEREFORE, THE LANTERN WAS REMOVED. THE PHYSICIAN THEN INSERTED A NEW LANTERN IN THE TARGET LOCATION AND ADVANCED ADDITIONAL POD PCS AND RUBY COILS INTO THE VESSEL. SUBSEQUENTLY, THE PHYSICIAN PULLED BACK ON THE LANTERN TO BE REMOVED AND NOTICED ALL OF THE PREVIOUSLY PLACED POD PCS AND RUBY COILS THAT WERE IMPLANTED HAD MIGRATED FROM THE SUBCLAVIAN ARTERY TO THE BRACHIAL ARTERY UNDER FLUOROSCOPY. THE LANTERN WAS REMOVED, AND THE PHYSICIAN PERFORMED A CUTDOWN SURGERY AND REMOVED THE MIGRATED POD PCS AND RUBY COILS. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797269 ↗
• MalfunctionMar 4, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO LOAD A RUBY COIL INTO THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND; CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED. THEREFORE, IT 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11416100 ↗
• MalfunctionOct 16, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER THE LANTERN WAS INSIDE THE PATIENT, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE INTRODUCING THE FIRST RUBY COIL. SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND TWENTY-THREE ADDITIONAL COILS INCLUDING RUBY COILS, POD PACKING COILS (POD PCS), AND POD 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 10691237 ↗
• MalfunctionSep 8, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRANCHES OF THE HYPOGASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE BRANCHES OFF OF THE HYPOGASTRIC ANEURYSM USING THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE AND SUBSEQUENTLY, THE RUBY COIL CONTINUED TO RUN DISTALLY DOWN THE VESSEL. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED SEVERAL TIMES TO HAVE THE RUBY COIL TAKE ITS INTENDED SHAPE; HOWEVER, WERE UNSUCCESSFUL. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL THROUGH THE MICROCATHETER; HOWEVER, THE RUBY COIL BECAME STUCK IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER WITH THE STUCK RUBY COIL WERE REMOVED TOGETHER AND NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL RUBY COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10502305 ↗
• MalfunctionJul 10, 2020Failure to Advance; Failure to Advance

  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 10261128 ↗
• MalfunctionOct 29, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING A POD10 AND RUBY COILS. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS EXTREMELY TORTUOUS. DURING THE PROCEDURE, THE POD10 PUSHER WIRE BECAME KINKED DURING ADVANCEMENT THROUGH THE INTRODUCER SHEATH. THEREFORE, THE POD10 WAS REMOVED. NEXT, THE PHYSICIAN WAS ADVANCING A RUBY COIL THROUGH LANTERN DELIVERY MICROCATHETER (LANTERN) TOWARDS THE TARGET LOCATION AND ENCOUNTERED RESISTANCE WHILE ADVANCING AROUND ONE BEND IN THE VASCULATURE. HOWEVER, THE PHYSICIAN DECIDED TO CONTINUE ADVANCING THE RUBY COIL AND REPORTED THAT IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE RUBY COIL AND LANTERN WERE REMOVED TOGETHER FROM THE PATIENT AND THE PHYSICIAN THEN REMOVED THE RUBY COIL FROM THE LANTERN. THE SAME LANTERN WAS THEN RE-ADVANCED AND USED TO COMPLETE THE PROCEDURE WITH ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252216 ↗
• MalfunctionJul 24, 2018Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE BACK OF THE PUSHER ASSEMBLY OF THE RUBY COIL WAS BENT AT A 90 DEGREE ANGLE UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING TWO NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 7716486 ↗