RUBY Coil RBY2C1460-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00814548019116), received between May 7, 2019 and Dec 18, 2023 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2023Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. AFTER FLUSHING THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE LANTERN. WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE DETACHED RUBY COIL INTO THE TARGET VESSEL BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE LANTERN CONTAINING THE RUBY COIL. UPON REMOVAL, THE PHYSICIAN FRACTURED THE RUBY COIL PUSHER ASSEMBLY. HOWEVER, THE LANTERN CONTAINING THE RUBY COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE RUBY COIL WAS THEN REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING THREE RUBY COILS, SEVEN POD PACKING COILS (POD PC), 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 18350155 ↗
• 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 16797153 ↗
• MalfunctionDec 7, 2021Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL IN THE TARGET VESSEL BUT DECIDED TO RETRACT THE COIL IN ORDER TO REPOSITION IT. WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN ENCOUNTERED SLIGHT RESISTANCE. SUBSEQUENTLY, THE RUBY COIL BECAME UNRAVELED AND UNINTENTIONALLY DETACHED. HOWEVER, THE PHYSICIAN WAS ABLE TO PLACE IT INTO THE ANEURYSM. IT IS UNKNOWN HOW THE PHYSICIAN PLACED THE COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957935 ↗
• MalfunctionOct 23, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVERAL COILS IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING A RUBY COIL INTO THE LANTERN, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN AND SUCCESSFULLY IMPLANTED IT. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL COILS 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 12686758 ↗
• MalfunctionApr 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, AFTER FLUSHING THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE PROXIMAL SEGMENT OF THE LANTERN. THE RUBY COIL WAS THEN RE-SHEATHED. DURING RE-ADVANCEMENT, THE PHYSICIAN ENCOUNTERED EVEN STRONGER RESISTANCE IN THE SAME LOCATION. THEREFORE, THE RUBY COIL WAS COMPLETELY REMOVED AND NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, TWO POD PACKING COILS (POD PCS), 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 11694661 ↗
• MalfunctionJan 15, 2021Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA MICROCATHETER AND 6F GUIDING SHEATH. DURING THE PROCEDURE, WHEN ADVANCING A RUBY COIL INTO THE LANTERN APPROXIMATELY 50CM, THE PHYSICIAN ENCOUNTERED RESISTANCE AND DECIDED TO REMOVE THE RUBY COIL. ON WITHDRAWAL, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE RUBY COIL WAS REMOVED BY WITHDRAWING THE PUSHER ASSEMBLY OF THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, FOUR POD PACKING COILS (POD PCS), FOUR NON-PENUMBRA COILS, AND THE SAME LANTERN AND THE NON-PENUMBRA 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 11178736 ↗
• MalfunctionSep 24, 2020Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY (RA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE COIL THROUGH THE LANTERN, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED. WHEN THE RUBY COIL WAS RETRACTED HALF-WAY OUT OF THE MICROCATHETER, IT UNINTENTIONALLY DETACHED. THEREFORE, THE RUBY COIL WAS PULLED OUT OF THE LANTERN AND REMOVED COMPLETELY FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING TWENTY-THREE RUBY COILS, POD PACKING COILS (POD PCS), 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 10584106 ↗
• MalfunctionAug 27, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THREE RUBY COILS IN THE ANEURYSM USING THE LANTERN. WHILE FORMING THE NEXT RUBY COIL IN THE ANEURYSM, THE RUBY COIL DID NOT FIT, AND THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COIL. IT SHOULD BE NOTED THAT THERE WAS NO REPORTED ISSUE WITH THE LANTERN. THE PROCEDURE WAS COMPLETED USING ANOTHER EIGHT SMALLER RUBY COILS AND ANOTHER LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10463494 ↗
• MalfunctionJul 30, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ARTERIOVENOUS MALFORMATION (AVM) USING POD COILS, RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A POD COIL AND RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. WHILE PLACING THE NEXT RUBY COIL IN ANOTHER HIGH-FLOW VESSEL, THE RUBY COIL WOULD NOT SIT. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10342622 ↗
• MalfunctionJun 5, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING RUBY COILS, RUB COIL DETACHMENT HANDLE (HANDLE) AND, NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE RUBY COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, THE SAME HANDLE AND, MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10125170 ↗
• MalfunctionApr 22, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INSERTING ANOTHER RUBY COIL INTO THE MICROCATHETER, THE PHYSICIAN CONTINUED TO ADVANCE THE RUBY COIL AGAINST RESISTANCE AND THE COIL BECAME STUCK INSIDE OF THE MICROCATHETER AND THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BROKEN. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WERE REMOVED. IT WAS REPORTED THAT THE RUBY COIL DID NOT COME OUT UPON FLUSHING THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, OTHER COILS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988693 ↗
• MalfunctionMar 20, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN. UPON ADVANCEMENT OF THE NEXT RUBY COIL APPROXIMATELY FIFTEEN CENTIMETERS INTO THE LANTERN, THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE. THE PHYSICIAN ATTEMPTED TO FLUSH THE DEVICES; HOWEVER, THE ISSUE WAS NOT RESOLVED. THEREFORE, THE RUBY COIL WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL, NINE ADDITIONAL 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 9862844 ↗
• MalfunctionDec 9, 2019Unraveled Material; Failure to Advance; Physical Resistance/Sticking; Unraveled Material; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH ITS INTRODUCER SHEATH. THE RUBY COIL WAS THEN REMOVED AND TESTED ON THE BACK TABLE. HOWEVER, IT WAS NOTED THAT THE RUBY COIL COULD BE ADVANCED AND WITHDRAWN. THEREFORE, THE PHYSICIAN ATTEMPTED TO RE-ADVANCE IT INTO THE MICROCATHETER. DURING RE-ADVANCEMENT, THE RUBY COIL BECAME STUCK INSIDE THE MICROCATHETER MID-SHAFT. WHILE ATTEMPTING TO REMOVE THE RUBY COIL FROM THE MICROCATHETER , THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE. SUBSEQUENTLY, THE RUBY COIL DETACHED AND UNRAVELED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, OTHER PENUMBRA COILS, AND A NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440480 ↗
• InjuryDec 9, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED LANTERN DELIVERY MICROCATHETER (LANTERN) AND PLACED FOUR RUBY COILS. DURING THE PLACEMENT OF FIFTH RUBY COIL, THE COIL UNINTENTIONALLY DETACHED IN THE VESSEL. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW GUIDE CATHETER, THE SAME LANTERN AND THREE ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9439036 ↗
• MalfunctionOct 17, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A VENOUS MALFORMATION IN THE LEG USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, AND SUBSEQUENTLY, THE RUBY COIL WOULD NOT ADVANCE OUT OF THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND 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 9203280 ↗
• MalfunctionJun 6, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND POD14S. DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL BECAME KINKED WHILE BEING REMOVED FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING THE POD14 INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN) AND, CONSEQUENTLY, THE POD14 UNINTENTIONALLY DETACHED. THE PHYSICIAN WAS ABLE TO PULL OUT THE POD14, AND THE PROCEDURE WAS THEN COMPLETED USING A POD12 AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8674899 ↗
• 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 8589240 ↗