RUBY Coil RBY2C1035-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00814548019062), received between Aug 13, 2018 and Jan 12, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) PROCEDURE IN THE CORONAL VEIN VARICES USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN BEGAN ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER. THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN USED SALINE TO FLUSH THE DETACHED COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048652 ↗
• MalfunctionFeb 20, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TESTICULAR VEIN USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MID-SHAFT OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING TWO 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

  MAUDE report 21429144 ↗
• MalfunctionDec 21, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL USING THE LANTERN; HOWEVER, THE RUBY COIL WAS NOT TAKING ITS INTENDED SHAPE IN THE TARGET VESSEL. AFTER APPROXIMATELY HALF OF THE RUBY COIL HAD BEEN RETRACTED OUT OF THE LANTERN, THE RUBY COIL BECAME KNOTTED AND UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. IT SHOULD BE NOTED THAT THERE WAS NO REPORTED DAMAGE TO THE LANTERN. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS (TORNADO PUSHABLE). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053997 ↗
• MalfunctionNov 12, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LOWER BRANCHES OF THE RENAL ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE WITHIN THE TARGET VESSEL. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUED OCCURRED WITH A SECOND RUBY COIL. THEREFORE, THE RUBY COIL WAS ALSO REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO TREAT DIFFERENT BRANCHES THAN THE INTENDED ORIGINAL VESSEL. THE PROCEDURE WAS COMPLETED USING RUBY COIL LPS AND A SMALLER SIZE NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807263 ↗
• MalfunctionJul 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL, AND LATER A RUBY COIL, INTO THE TARGET LOCATION, THE PHYSICIAN LOST ACCESS WITH THE LANTERN DUE TO THE TORTUOSITY AND LACK OF SUPPORT WITH THE LANTERN. THE POD COIL AND RUBY COIL WERE REMOVED AND RE-SHEATHED. SUBSEQUENTLY, THE PHYSICIAN RE-ACCESSED THE VESSEL WITH THE LANTERN AND THEN EXPERIENCED RESISTANCE WHEN ADVANCING THE SAME POD COIL AND RUBY COIL THROUGH THE LANTERN. THEREFORE, THE POD COIL AND RUBY COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, A NEW 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 12131967 ↗
• 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 10946228 ↗
• MalfunctionSep 8, 2020Failure to Fold; Failure to Fold

  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 10502301 ↗
• MalfunctionAug 6, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH THE POD COIL USING THE HANDLE. HOWEVER, THE HANDLE FAILED TO ATTACH THE POD COIL. SUBSEQUENTLY, THE POD COIL WAS REMOVED, AND THE PHYSICIAN IMPLANTED TWO PENUMBRA COILS IN THE VESSEL. THE PHYSICIAN THEN ADVANCED THE NEXT POD COIL AND A RUBY COIL SEPARATELY TO THE VESSEL, BUT THE SAME ISSUE OCCURRED; THE HANDLE FAILED TO DETACH THE POD COIL AND RUBY COIL. THEREFORE, THE POD COIL AND RUBY COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PENUMBRA COIL 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 10376103 ↗
• MalfunctionJun 3, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HYPOGASTRIC ARTERY USING A RUBY COIL, RUBY COIL DETACHMENT HANDLES (HANDLE) AND POD COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET VESSEL AND USED A HANDLE TO DETACH IT; HOWEVER, THE RUBY COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, WHILE REMOVING A POD COIL FROM THE PACKAGING HOOP, THE HOSPITAL TECHNICIAN NOTICED THE PUSHER ASSEMBLY OF THE POD COIL WAS BENT; THEREFORE, THE POD COIL WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ADVANCED A NEW POD COIL INTO THE TARGET VESSEL AND USED THE SAME HANDLE TO DETACH IT; HOWEVER, THE POD COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN REMOVED THE HANDLE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE TO DETACH THE SAME POD COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10116517 ↗
• MalfunctionMay 28, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND, A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN DETACHED A RUBY COIL IN THE TARGET VESSEL USING A HANDLE; HOWEVER, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME STUCK IN THE HANDLE. THEREFORE, THE HANDLE AND THE PUSHER ASSEMBLY OF THE RUBY COIL WERE REMOVED. NEXT, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE LANTERN. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE RUBY COIL TO PUSH THE DETACHED RUBY COIL INTO VESSEL. THE PROCEDURE WAS THEN COMPLETED USING A NEW HANDLE, ADDITIONAL RUBY COILS, OTHER 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 10097434 ↗
• MalfunctionMay 7, 2019Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING RUBY COILS, THE PUSHER WIRES OF TWO RUBY COILS BECAME BENT UPON REMOVAL FROM PACKAGING. THE RUBY COILS WERE THEREFORE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8589241 ↗
• MalfunctionMay 2, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE RUBY COIL WITHIN ITS INTRODUCER SHEATH ON THE BACK TABLE, HOWEVER, WAS UNABLE TO. THE PROCEDURE WAS THEN 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 8575455 ↗
• MalfunctionFeb 15, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PELVIC CONGESTION USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 8345621 ↗
• MalfunctionDec 14, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COIL¿S IN THE TARGET VESSEL. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN). THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8166516 ↗
• MalfunctionDec 5, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE RUBY COIL WITHIN ITS INTRODUCER SHEATH ON THE BACK TABLE BUT WAS UNSUCCESSFUL. THEREFORE, 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 8135401 ↗
• MalfunctionAug 13, 2018Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE PUSHER ASSEMBLY OF THE RUBY COIL WAS KINKED ON THE BACK TABLE. 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 A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7779180 ↗