RUBY Coil RBY2C0725-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI M424RBY2C07250), received between Oct 21, 2015 and Jun 23, 2021 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HYPOGASTRIC ARTERY USING POD COILS, RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A POD COIL WAS ADVANCED TO THE TARGET VESSEL; HOWEVER, THE POD COIL WAS DETERMINED TO BE TOO SMALL. THEREFORE, THE POD COIL WAS REMOVED INTACT. THEN, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL; HOWEVER, THE RUBY COIL WAS ALSO DETERMINED TO BE TOO SMALL. THEREFORE, THE RUBY COIL WAS REMOVED AND SAVED FOR LATER USE. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER POD COIL IN THE TARGET VESSEL. NEXT, THE PHYSICIAN RE-ADVANCED THE PREVIOUSLY REMOVED RUBY COIL TO THE TARGET VESSEL; HOWEVER, THE RUBY COIL WAS DETERMINED TO BE TOO SMALL AGAIN. THEREFORE, THE RUBY COIL WAS RE-SHEATHED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER RUBY COIL IN THE TARGE VESSEL. WHILE ATTEMPTING TO RE-ADVANCE THE PREVIOUSLY REMOVED RUBY COIL THROUGH THE LANTERN A THIRD TIME, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12052463 ↗
• MalfunctionJul 10, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SIX RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. DURING THE DETACHMENT OF THE SEVENTH COIL, AFTER PULLING THE TRIGGER, ONE OF THE TWO BLACK LINES ON THE BACK OF THE PUSHER WIRE WAS MISSING AND THE COIL WAS STILL ATTACHED, THEREFORE, THE RUBY COIL AND THE HANDLE WERE REMOVED. A NEW HANDLE WAS USED WITH THE SAME RUBY COIL AND UPON DETACHMENT OF THE RUBY COIL THE PUSHER ASSEMBLY GOT STUCK IN THE HANDLE BUT THE RUBY COIL WAS SUCCESSFULLY DETACHED. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776984 ↗
• MalfunctionAug 9, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7768098 ↗
• MalfunctionJul 13, 2018Failure to Advance; Failure to Advance

  WHILE PREPARING A RUBY COIL ON THE BACK TABLE FOR A COIL EMBOLIZATION PROCEDURE, THE RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN).

  Patient problems: No Patient Involvement

  MAUDE report 7687699 ↗
• MalfunctionJul 3, 2018Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ACCESSORY RENAL ARTERY AND THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A POD6. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE INITIAL TWO COILS IN THE ACCESSORY RENAL ARTERY USING A NON-PENUMBRA ARTERY. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND BENT THE RUBY COIL PUSHER ASSEMBLY TWICE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO PLACE A NEW RUBY COIL IN THE IMA, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO RE-SHEATH THE RUBY COIL, THE HOSPITAL TECHNOLOGIST PULLED THE RUBY COIL PASSED THE FRICTION LOCK AND THE EMBOLIZATION COIL WAS COMING OUT OF THE PROXIMAL END OF THE INTRODUCER SHEATH. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL IN THE IMA; HOWEVER, THE RUBY COIL DID NOT TAKE ITS INTENDED SHAPE AND THEREFORE, WAS REMOVED. IT WAS REPORTED THE RUBY COIL PUSHER ASSEMBLY WAS KINKED. NEXT, THE PHYSICIAN ADVANCED TWO OTHER RUBY COILS IN THE IMA, BUT THE RUBY COILS DID NOT TAKE THEIR INTENDED SHAPE; THEREFORE, THEY WERE REMOVED. WHILE ADVANCING A POD6 INTO THE IMA, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659257 ↗
• MalfunctionMar 14, 2018Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY TO TREAT A TYPE II ENDOLEAK USING RUBY COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) INTO THE TARGET LOCATION, AND THOUGH THE PHYSICIAN WAS USING CONTINUOUS FLUSH, BLOOD ENTERED THE INTRODUCER SHEATH OF A RUBY COIL AS THE TECHNICIAN ATTEMPTED TO ADVANCE THE RUBY COIL. THE TECHNICIAN FELT RESISTANCE ADVANCING THE RUBY COIL, AND THEREFORE THE RUBY COIL WAS REMOVED AND A NEW RUBY COIL WAS PLACED. THE PHYSICIAN REPOSITIONED THE LANTERN AND THEN ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER THE TECHNICIAN FELT RESISTANCE ADVANCING THE RUBY COIL WITHIN ITS INTRODUCER SHEATH, AND THEREFORE THE RUBY COIL WAS REMOVED. A NEW RUBY COIL WAS THEN SUCCESSFULLY PLACED. THE TECHNICIAN THEN AGAIN FELT RESISTANCE ADVANCING ANOTHER RUBY COIL WITHIN ITS INTRODUCER SHEATH, AND THE RUBY COIL WAS THEREFORE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING THE SAME LANTERN, A NEW RUBY COIL, A POD5, AND A POD PACKING COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7337697 ↗
• MalfunctionDec 26, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DIALYSIS FISTULA IN THE ULNAR VEIN USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL PUSHER ASSEMBLY BECAME KINKED AND SUBSEQUENTLY, RESISTANCE WAS MET UPON ADVANCING THE RUBY COIL INTO THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 7146185 ↗
• MalfunctionOct 17, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJS) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH ITS INTRODUCER SHEATH ON THE BACK TABLE AND FOUND THAT THE PUSHER WIRE HAD BECOME KINKED. THE PODJ WAS THEREFORE NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN FELT STRONG RESISTANCE WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER AND THEREFORE, THE RUBY COIL WAS REMOVED. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE PUSHER WIRE OF THE RUBY COIL WAS KINKED. THE PROCEDURE WAS THEN COMPLETED USING THE SAME MICROCATHETER AND ADDITIONAL PODJS AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6956564 ↗
• MalfunctionMay 30, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK AFTER BEING ADVANCED 2/3 INTO THE ANEURYSM. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY IN THE PATIENT¿S BODY AND THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE ENTIRE DETACHED COIL FROM THE PATIENT. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE SAME PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL. HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY WITHIN THE PX SLIM. THE PHYSICIAN WAS ABLE TO SECURELY PUSH THE DETACHED COIL INTO THE ANEURYSM AND THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6599527 ↗
• MalfunctionMay 26, 2017Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE AN INITIAL RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND DECIDED TO REMOVE THE COIL. WHILE THE PHYSICIAN WAS ATTEMPTING TO RESHEATH THE RUBY COIL OUTSIDE OF THE PATIENT'S BODY, THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PROCEDURE WAS COMPLETED USING 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 6594417 ↗
• MalfunctionMay 19, 2017Failure to Advance; Physical Resistance; Device Operates Differently Than Expected; Failure to Advance; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL MORE THAN HALFWAY THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN FLUSHED THE LANTERN AND SUCCESSFULLY ADVANCED A GUIDEWIRE THROUGH THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE RUBY COIL AGAIN; HOWEVER MET THE SAME RESISTANCE AND THEREFORE, REMOVED THE RUBY COIL. THE PROCEDURE WAS THEN COMPLETED USING THE SAME LANTERN 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 6579903 ↗
• MalfunctionMay 19, 2017Failure to Advance; Physical Resistance; Device Operates Differently Than Expected; Failure to Advance; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO RUBY COILS USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM; THEREFORE THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM 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 6579268 ↗
• MalfunctionOct 20, 2016Retraction Problem; Failure to Advance; Mechanical Jam; Retraction Problem; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRONCHIAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE BEING ADVANCED THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A RUBY COIL BECAME LODGED INSIDE THE PX SLIM AND WOULD NOT RETRACT NOR ADVANCE. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND THE PX SLIM ALL TOGETHER FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND A NEW MICROCATHETER. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) BUT DID NOT MAINTAIN CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6044710 ↗
• MalfunctionJul 26, 2016Detachment Of Device Component; Retraction Problem; Inadequacy of Device Shape and/or Size; Detachment Of Device Component; Retraction Problem; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A RUBY COIL INTO THE ANEURYSM USING A LANTERN DELIVERY MICROCATHETER (LANTERN) BUT THOUGHT THAT THE COIL WAS UNDERSIZED AND DECIDED TO RESHEATH THE COIL. WHILE THE PHYSICIAN WAS RESHEATHING THE RUBY COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN DID NOT MENTION ANY RESISTANCE WHILE ATTEMPTING TO RESHEATH THE COIL. THE ENTIRE LANTERN CONTAINING THE DETACHED COIL WAS THEN REMOVED. NEXT, A NEW LANTERN WAS OPENED AND ADVANCED INTO THE PATIENT. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE NEW LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE RUBY COIL WAS REMOVED INTACT AND ANOTHER MANUFACTURER'S COIL WAS PLACED IN THE ANEURYSM. AFTER PLACING THE OTHER MANUFACTURER'S COIL, THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE BY DEPLOYING AND DETACHING THREE NEW RUBY COILS USING THE SECOND LANTERN. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT HAVE A CONTINUOUS FLUSH AND WAS NOT USING A ROTATING HEMOSTASIS VALVE (RHV). HOWEVER, THE PHYSICIAN DID FLUSH BEFORE AND AFTER EVERY COIL. ADDITIONALLY,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5823522 ↗
• MalfunctionOct 28, 2015Bent; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT AND THE RUBY COIL UNINTENTIONALLY DETACHED OUTSIDE THE PATIENT'S BODY. 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 5186062 ↗
• MalfunctionOct 21, 2015Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING RUBY COILS AND POD8 COILS. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE TARGET VESSEL USING ANOTHER MANUFACTURER'S MICROCATHETER. HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO DIFFERENT RUBY COILS AND TWO DIFFERENT POD8 COILS THROUGH THE MICROCATHETER AND THEY WERE REMOVED ALONG WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURERS' VASCULAR PLUG AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5167316 ↗