RUBY Coil RBY4C0620-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00814548018355), received between Feb 6, 2019 and Jun 25, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON HEPATIC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND AN ACCESS SHEATH. THE PHYSICIAN ADVANCED THE ACCESS SHEATH INTO THE COELIAC TRUNK FOLLOWED BY A STENT ACROSS THE NECK OF THE ANEURYSM. WHILE ADVANCING THE FOURTH RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE COIL WAS REMOVED FROM THE PATIENT UNDER ASPIRATION. ON THE BACK TABLE, THE PHYSICIAN PULLED THE COIL OUT OF THE MICROCATHETER, WHICH RESULTED IN THE COIL TO UNRAVEL. A NEW MICROCATHETER OF THE SAME TYPE WAS THEN INTRODUCED TO THE PATIENT AND A DIAGNOSTIC CATHETER WAS USED AS SUPPORT. FOUR ADDITIONAL COILS WERE THEN IMPLANTED IN THE TARGET LOCATION. WHILE ADVANCING THE FINAL RUBY COIL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A GUIDEWIRE TO PUSH THE DETACHED RUBY COIL INTO THE TARGET LOCATION AND REMOVED THE MICROCATHETER. THE PHYSICIAN BEGAN TO REMOVE THE DIAGNOSTIC CATHETER AND OBSERVED THAT THE PROXIMAL END OF THE RUBY COIL MOVED WHEN THE DIAGNOSTIC CATHETER WAS RETRACTED. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627490 ↗
• MalfunctionJun 17, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERIOVENOUS MALFORMATIONS (AVM) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET LOCATION USING THE LANTERN. WHILE ADVANCING ANOTHER RUBY COIL INTO THE TARGET LOCATION, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING 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 22216819 ↗
• MalfunctionDec 26, 2023Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (POD PC), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS AND TWO POD PCS IN TARGET VESSEL USING THE LANTERN. IT WAS REPORTED THAT THE GUIDEWIRE WAS EXTENDED PAST THE TARGET VESSEL FOR SUPPORT. WHEN THE PHYSICIAN BEGAN TO REMOVE THE GUIDEWIRE, ALL OF THE PREVIOUSLY PLACED COILS THAT WERE IMPLANTED MIGRATED TO THE MAIN SPLENIC ARTERY. AFTER PERFORMING AN ANGIOGRAM, THE PHYSICIAN DECIDED TO LEAVE THE COILS IN THE MAIN SPLENIC ARTERY. 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 18393338 ↗
• 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 15048143 ↗
• InjuryOct 21, 2021Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE RUBY COIL IN THE TARGET VESSEL USING THE LANTERN; HOWEVER, DUE TO THE RETROGRADE FLOW OF THE VESSEL, THE RUBY COIL MIGRATED INTO THE SPLENIC ARTERY. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE RUBY COIL. WHILE ATTEMPTING TO REMOVE THE COIL, THE PHYSICIAN WAS UNABLE TO TRACK THE LANTERN CLOSE ENOUGH TO THE RUBY COIL. THEREFORE, THE LANTERN WAS REMOVED AND A NON-PENUMBRA MICROCATHETER WAS USED TO REMOVE THE COIL. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS AND NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674115 ↗
• MalfunctionJul 17, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE FIRST RUBY COIL THROUGH THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN FELT THE RUBY COIL UNINTENTIONALLY DETACH INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER AND RUBY COIL WERE REMOVED FROM THE PATIENT TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER WITH ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290736 ↗
• MalfunctionApr 29, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GASTRIC FUNDAL VARICES USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE RUBY COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A ADDITIONAL 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 10010411 ↗
• MalfunctionAug 20, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE RUBY COIL KINKED WHILE ADVANCING INTO A LANTERN DELIVERY MICROCATHETER (LANTERN), THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING TWO NEW 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 8913104 ↗
• MalfunctionApr 17, 2019Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL WAS BENT WHILE BEING RELOADED INTO THE PACKAGING HOOP. 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 8522641 ↗
• MalfunctionFeb 6, 2019Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT ARTERIOVENOUS (AV) FISTULAS IN THE PATIENT¿S LEG USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE VESSELS WERE DIFFICULT TO ACCESS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY POSITIONED A GUIDEWIRE, NON-PENUMBRA CATHETER, AND A LANTERN INTO THE TARGET VESSEL AND DEPLOYED FOUR RUBY COILS. THE TECHNICIAN THEN FELT RESISTANCE WHILE ADVANCING THE FIFTH RUBY COIL AND WAS ONLY ABLE TO ADVANCE 90% OF THE COIL INTO THE LANTERN BEFORE THE RUBY COIL BECAME KINKED. THE RUBY COIL WAS THEREFORE REMOVED. WHILE ADVANCING THE SIXTH RUBY COIL, THE TECHNICIAN AGAIN FELT RESISTANCE AND SAME ISSUE OCCURRED. THE SIXTH RUBY COIL WAS, THEREFORE, REMOVED. THE LANTERN WAS THEN REMOVED FROM THE PATIENT AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE LANTERN AND NO VISIBLE DAMAGE; HOWEVER, THE LANTERN WAS SET ASIDE AND A NEW LANTERN WAS USED TO CONTINUE THE PROCEDURE. THE SAME GUIDEWIRE AND THE SAME NON-PENUMBRA CATHETER WERE ALSO USED. THE PHYSICIAN THEN DECIDED TO RE-POSITION THE GUIDEWIRE, NON-PENUMBRA CATHETER, AND NEW LANTERN TOGETHER IN ORDER TO REGAIN ACCESS TO THE TARGET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313266 ↗