RUBY Coil RBY4C0202-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00814548018263), received between Nov 30, 2018 and Jul 7, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT PULMONARY ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE VESSEL, BUT THE COIL DID NOT FORM AS DESIRED IN THE VESSEL. THEREFORE, THE RUBY COIL WAS RE-SHEATHED AND REMOVED. AFTER REGAINING ACCESS TO THE TARGET LOCATION, THE PHYSICIAN BEGAN ADVANCING THE SAME RUBY COIL INTO THE VESSEL, HOWEVER, IT WAS NOT FORMING CORRECTLY. THE PHYSICIAN THEN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22416976 ↗
• MalfunctionSep 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL APPROXIMATELY 10CM INTO THE INTRODUCER SHEATH AND THE RUBY COIL WOULD NOT ADVANCE FURTHER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442161 ↗
• MalfunctionAug 26, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL KINKED WHILE LOADING THE COIL INTO THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED FROM THE LANTERN. 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 12375018 ↗
• MalfunctionJul 29, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS, RUBY COIL DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH THE SAME HANDLE AND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249440 ↗
• MalfunctionJan 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PELVIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO DEPLOY THE RUBY COIL; THEREFORE, THE RUBY COIL WAS REMOVED. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11148683 ↗
• MalfunctionOct 9, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING COIL A EMBOLIZATION PROCEDURE IN THE DISTAL SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL, THE SAME MICROCATHETER AND HANDLE. 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 10656454 ↗
• MalfunctionJul 17, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OBTURATOR ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE RUBY COIL AROUND A TIGHT BEND IN THE DISTAL ASPECT OF THE MICROCATHETER. THE RUBY COIL WAS RE-SHEATHED AND REMOVED FROM THE MICROCATHETER WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290795 ↗
• MalfunctionJun 18, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 10171907 ↗
• MalfunctionApr 4, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROINTESTINAL (GI) REGION USING RUBY COILS, PACKING COIL LPS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO PLACE IT, BUT THE RUBY COIL WAS NOT TAKING ITS INTENDED SHAPE. THE PHYSICIAN THEN DECIDED TO RE-SHEATH THE RUBY COIL, BUT IT HAD FORMED A KNOT; THEREFORE, THE RUBY COIL WAS REMOVED AND NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN ADVANCED A PACKING COIL LP TO THE VESSEL USING ANOTHER MICROCATHETER AND ATTEMPTED TO PLACE IT, BUT THE SAME ISSUE OCCURRED; THEREFORE, THE PACKING COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PACKING COIL LP 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 9926187 ↗
• MalfunctionDec 9, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT'S ANATOMY HAD AN EXTREME ANGLE PRIOR TO AREA TO EMBOLIZE. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE THROUGH THE NON-PENUMBRA MICROCATHETER AROUND THE ANGULATION AREA. IT WAS REPORTED THAT THE COIL TO PUSHER ASSEMBLY TRANSITION WOULD NOT CROSS; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440807 ↗
• MalfunctionNov 26, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL; HOWEVER, THE SAME RESISTANCE ISSUE OCCURRED, AND THE RUBY COIL BECAME STUCK IN THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 9377877 ↗
• MalfunctionSep 10, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL ARTERIES USING RUBY COILS. DURING THE PROCEDURE, RUBY COILS WERE SUCCESSFULLY PLACED IN THE TARGET VESSEL WITH A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL OUT OF ITS INTRODUCER SHEATH, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE. THE TECHNOLOGIST CONTINUED TO PUSH THE RUBY COIL AND EXPERIENCED MORE RESISTANCE; THEREFORE, IT WAS REMOVED. 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 8981102 ↗
• MalfunctionMay 23, 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 PUSHER WIRE OF A RUBY COIL BECAME KINKED UPON REMOVAL FROM ITS PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE, AND THEREFORE THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND POD COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8636468 ↗
• MalfunctionMar 22, 2019Failure to Advance; Device Dislodged or Dislocated; Premature Separation; Failure to Advance; Device Dislodged or Dislocated; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT CIRCUMFLEX ARTERY IN THE ARM USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE TARGET VESSEL VIA THE FEMORAL ARTERY ON THE RIGHT SIDE, AND ATTEMPTED TO DETACH THE FIRST RUBY COIL. HOWEVER, THE RUBY COIL AND LANTERN TOGETHER KICKED BACK OUT OF THE TARGET VESSEL AND SLIPPED OUT. IN ORDER TO BEGIN REPOSITIONING THE LANTERN AND RE-GAIN ACCESS TO THE TARGET VESSEL, THE TECHNICIAN FIRST BEGAN RESHEATHING THE RUBY COIL. WHILE RETRACTING THROUGH THE MICROCATHETER, THE RUBY COIL DETACHED FROM ITS PUSHER WIRE AND BECAME LODGED IN THE RHV. IT WAS ALSO NOTED THAT THE TECHNICIAN WAS WRAPPING THE RUBY COIL WIRE IN A LOOP WHILE RETRACTING. THE RUBY COIL WAS THEN REMOVED AND THE RHV WAS FLUSHED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA COIL OF THE SAME SIZE, TWO ADDITIONAL COILS, THE SAME CATHETER, 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 8445022 ↗
• MalfunctionMar 8, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERCOSTAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, TWO RUBY COILS WERE NOT TAKING THEIR INTENDED SHAPE, DESPITE BEING THE CORRECT SIZE FOR THE TARGET LOCATION. THEREFORE, THE RUBY COILS WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405127 ↗
• MalfunctionMar 8, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERCOSTAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, TWO RUBY COILS WERE NOT TAKING THEIR INTENDED SHAPE, DESPITE BEING THE CORRECT SIZE FOR THE TARGET LOCATION. THEREFORE, THE RUBY COILS WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405122 ↗
• MalfunctionFeb 22, 2019Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL WAS BENT UPON REMOVAL FROM ITS PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8362766 ↗
• MalfunctionJan 11, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF FOUND THAT A RUBY COIL PUSHER ASSEMBLY WAS KINKED UPON REMOVAL FROM THE DISPENSER 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 ANOTHER RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8241501 ↗
• MalfunctionDec 18, 2018Device Damaged Prior to Use; Device Fell; Device Damaged Prior to Use; Device Fell

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE HOSPITAL STAFF INADVERTENTLY DROPPED A RUBY COIL ON THE FLOOR UPON OPENING THE PACKAGE, PRIOR TO USE; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING TWO OTHER RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8173470 ↗
• MalfunctionDec 13, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL BECAME CONTAMINATED BEFORE 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 8162057 ↗
• MalfunctionNov 30, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST RUBY COIL SUCCESSFULLY INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL, HOWEVER, IT DID NOT ADVANCE COMPLETELY THROUGH ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL, ADDITIONAL 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 8120614 ↗