RUBY Coil RBY2C0305-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00814548018546), received between May 8, 2019 and Aug 4, 2023 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. HOWEVER, WHILE RETRACTING, THE PHYSICIAN STILL EXPERIENCED RESISTANCE AND THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT. THE MICROCATHETER WAS THEN REINSERTED BACK INTO THE VESSEL. SUBSEQUENTLY, IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT TWO RUBY COILS. BOTH DETACHED RUBY COILS WERE CONTAINED INSIDE OF THE MICROCATHETER AND THE MICROCATHETER WAS REMOVED. BOTH RUBY COILS WERE THEN FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW 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

  MAUDE report 17466778 ↗
• MalfunctionAug 4, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. HOWEVER, WHILE RETRACTING, THE PHYSICIAN STILL EXPERIENCED RESISTANCE AND THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT. THE MICROCATHETER WAS THEN REINSERTED BACK INTO THE VESSEL. SUBSEQUENTLY, IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT TWO RUBY COILS. BOTH DETACHED RUBY COILS WERE CONTAINED INSIDE OF THE MICROCATHETER AND THE MICROCATHETER WAS REMOVED. BOTH RUBY COILS WERE THEN FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW 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

  MAUDE report 17466777 ↗
• MalfunctionJun 3, 2022Failure to Fold; Material Deformation; Premature Separation; Failure to Fold; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPO I ENDOLEAK USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE LOADING THE RUBY COIL, THE HOSPITAL TECHNICIAN NOTICED THE RUBY COIL WAS KINKED; HOWEVER, THE PHYSICIAN DECIDED TO CONTINUE AND USE THE KINKED RUBY COIL. SUBSEQUENTLY, WHEN THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE RUBY COIL HAD NOT TAKEN ITS INTENDED SHAPE WITHIN THE VESSEL AND DECIDED TO RETRACT THE RUBY COIL BACK INTO THE INTRODUCER SHEATH. HOWEVER, WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN NOTICED THE RUBY COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A BALLOON CATHETER TO REMOVE THE DETACHED RUBY COIL. 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 14596867 ↗
• MalfunctionFeb 16, 2022Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING A RUBY COIL IN THE DISTAL PART OF THE MICROCATHETER. SUBSEQUENTLY, THE PUSHER WIRE OF THE RUBY COIL BROKE, AND THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEN, THE PHYSICIAN USED A SALINE INJECTION TO PUSH THE RUBY COIL INTO THE VESSEL. THE PROCEDURE 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 13545700 ↗
• MalfunctionOct 28, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) AND INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN KINKED THE RUBY COIL UPON INSERTING IT INTO THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, WHILE ADVANCING A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED THE RUBY COIL STARTED TO TAKE SHAPE WITHIN THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME LANTERN. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712181 ↗
• MalfunctionJun 15, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL TO THE DISTAL TIP OF THE MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN INSERTED A NEW RUBY COIL AND ATTEMPTED TO ADVANCE IT THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN WAS UNABLE TO ADVANCE THE RUBY COIL TO THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 12004561 ↗
• MalfunctionJun 9, 2021Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT FOURTH LUMBAR ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THE LUMBAR ARTERY WAS VERY TORTUOUS, MAKING WHAT APPEARED TO BE CLOSE TO 90 DEGREES BEND BEFORE THE INTENDED LANDING ZONE. DURING THE PROCEDURE, A RUBY COIL (F103384) WOULD NOT FULLY EXIT THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE NEXT RUBY COIL (F101241) WOULD ONLY PARTIALLY EXIT THE MICROCATHETER, AND THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF A NON-PENUMBRA COIL TO PUSH THE COIL WHERE THE PHYSICIAN WANTED. THE PROCEDURE 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 11966109 ↗
• MalfunctionMar 27, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF A RUBY COIL AFTER ADVANCING A FEW CENTIMETERS INTO THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NEW RUBY COILS AND THE SAME LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579740 ↗
• MalfunctionDec 16, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INSERT A RUBY COIL INTO THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE INTO THE LANTERN EVEN AFTER ADJUSTING THE LANTERN CONNECTION. THEREFORE, THE RUBY COIL WAS REMOVED. 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; No Consequences Or Impact To Patient

  MAUDE report 11023272 ↗
• MalfunctionOct 11, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL BRANCH USING POD PACKING COILS (POD PC), RUBY COILS AND, A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED POD PCS IN THE TARGET VESSEL USING A LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER POD PC, IT UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO CAPTURE THE DETACHED POD PC. HOWEVER, THE POD PC BROKE OFF UPON BEING SNARED AND, THEREFORE, THE PHYSICIAN ADVANCED A LARGER NON-PENUMBRA CATHETER OVER THE THREAD OF THE POD PC AND THE REMAINING COIL WAS PULLED INTO THE CATHETER TO ENSURE THE COIL DID NOT MIGRATE INTO UNWANTED VESSEL AND, SUCCESSFULLY REMOVED THE POD PC. NEXT, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE LANTERN; HOWEVER, IT BECAME STUCK AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MANAGED VENTRICULAR PACING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182837 ↗
• MalfunctionJun 12, 2019Separation Problem; Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET VESSEL WITH A LANTERN DELIVERY MICROCATHETER (LANTERN) AND REPORTED THAT THE RUBY COIL WAS UNABLE TO DETACH USING THE HANDLE. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SAME HANDLE 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 8691203 ↗
• MalfunctionMay 8, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

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

  Patient problems: No Patient Involvement

  MAUDE report 8591881 ↗