RUBY Coil RBY2C0620-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI M424RBY2C06200), received between Jan 5, 2016 and May 10, 2021 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, ONE RUBY COIL WAS SUCCESSFULLY IMPLANTED IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A SECOND RUBY COIL INTO THE MICROCATHETER, THE RUBY COIL KEPT KICKING BACK AND WOULD NOT ADVANCE PAST THE HUB OF THE MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 11803302 ↗
• MalfunctionFeb 6, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE RUBY COIL WAS ADVANCED INTO THE TARGET VESSEL BUT DID NOT DETACH AFTER THREE ATTEMPTS USING THE HANDLE. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A POD PACKING COIL (POD PC) AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678701 ↗
• MalfunctionJan 29, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD PACKING COILS (POD PCS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING TWO RUBY COILS AND A POD PC THROUGH THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE RUBY COILS AND POD PC WERE REMOVED. 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 9643670 ↗
• MalfunctionJun 18, 2019Retraction Problem; Detachment of Device or Device Component; Mechanical Jam; Retraction Problem; Detachment of Device or Device Component; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO IMPLANT A RUBY COIL INTO THE TARGET VESSEL AND REPORTED THAT IT WOULD NOT ANCHOR. THE RUBY COIL WAS THEN RETRACTED. HOWEVER, WHILE RETRACTING THE RUBY COIL BACK INTO ITS INTRODUCER SHEATH, THE PHYSICIAN REPORTED DIFFICULTY RE-SHEATHING. THE PHYSICIAN DECIDED TO PULL THE RUBY COIL WITH GREATER FORCE AWAY FROM THE MICROCATHETER AND SUBSEQUENTLY THE RUBY COIL BECAME DETACHED PARTLY WITHIN ITS INTRODUCER SHEATH AND PARTLY OVER THE STERILE FIELD. THE RUBY COIL AND INTRODUCER SHEATH WERE THEN DISCARDED AND THE PROCEDURE WAS COMPLETED USING A POD6 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 8708155 ↗
• MalfunctionNov 10, 2017Detachment Of Device Component; Retraction Problem; Detachment of Device or Device Component; Detachment Of Device Component; Retraction Problem; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING A RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED SEVERAL RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO DEPLOY A NEW RUBY COIL IN THE TARGET VESSEL, THE PHYSICIAN DID NOT LIKE THE WAY THE RUBY COIL LANDED AND DECIDED TO REMOVE IT; HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. AFTER THAT, THE LANTERN WAS REINSERTED INTO THE PATIENT¿S BODY, AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7023153 ↗
• MalfunctionAug 1, 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 A RUBY COIL THROUGH THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. SUBSEQUENTLY THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A DIAGNOSTIC CATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6756977 ↗
• MalfunctionJul 13, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTRO-DUODENAL ARTERY (GDA) BLEED USING POD PACKING COIL (PODJ). DURING THE PROCEDURE, AFTER ADVANCING ABOUT 55 CM OF PODJ IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN REACHED THE OSTIUM OF THE GDA AND RAN OUT OF SPACE TO DEPLOY THE REMAINING FIVE CENTIMETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PODJ. WHILE ATTEMPTING TO RETRACT THE PODJ, THE PHYSICIAN DID NOT MENTION RESISTANCE; HOWEVER, THE PODJ UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY WITH FIFTEEN CENTIMETER OF THE COIL IN THE MICROCATHETER. AFTER ATTEMPTING TO REMOVE THE PODJ AND THE MICROCATHETER UNDER ASPIRATION, THE PODJ ENDED UP IN THE COMMON HEPATIC ARTERY. THEREFORE, THE PHYSICIAN USED A MICRO SNARE DEVICE WITH A 5F NON-PENUMBRA CATHETER TO REMOVE THE DETACHED PODJ FROM THE PATIENT'S BODY. IT WAS REPORTED THAT IT TOOK APPROXIMATELY 30 MINUTES TO SNARE THE COIL WHILE ADDING SIGNIFICANT FLUOROSCOPY TIME TO THE CASE. THE PHYSICIAN THEN INSERTED A NEW NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL AND ATTEMPTED TO LOAD A NEW PODJ; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PODJ WOULD NOT ADVANCE THOUGH THE MICRO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710756 ↗
• InjuryMay 9, 2017Bent; Detachment Of Device Component; Device Handling Problem; Bent; Detachment Of Device Component; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A LIVER ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS. IT WAS REPORTED THAT COILS WERE PREVIOUSLY PLACED IN THE TARGET VESSEL DURING PREVIOUS CASES. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN INADVERTENTLY BENT THE RUBY COIL PUSHER ASSEMBLY. THE PHYSICIAN WAS ADVISED TO REMOVE THE RUBY COIL; HOWEVER, THE PHYSICIAN INSISTED THAT THE RUBY COIL WAS FINE AND DID NOT REMOVE THE RUBY COIL. IT WAS REPORTED THAT WHILE ATTEMPTING TO PLACE THE RUBY COIL INTO THE ANEURYSM, THE LANTERN KICKED BACK INTO THE CATHETER AND THE PHYSICIAN DID NOT LIKE THE WAY THE RUBY COIL WAS POSITIONING IN THE ANEURYSM. AFTER REPOSITIONING THE RUBY COIL SEVERAL TIMES, IT UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY WITH HALF OF THE RUBY COIL INSIDE THE LANTERN AND THE OTHER HALF IN THE PATIENT¿S BODY. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. THE PHYSICIAN THEN REGAINED ACCESS, PLACED AND INFLATED A NON-PENUMBRA BALLOON CATHETER IN ORDER TO ATTEMPT TO USE GLUE; HOWEVER, THE PATIENT WAS UNSTABLE AND THE PHYSICIAN WAS UNABLE TO USE THE GLUE. T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6555829 ↗
• MalfunctionMay 1, 2017Kinked; Failure to Advance; Physical Resistance; Kinked; Failure to Advance; 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 NON-PENUMBRA MICROCATHETER, THE SCRUB TECHNOLOGIST EXPERIENCED RESISTANCE AND THE RUBY COIL KEPT GETTING STUCK IN THE MICROCATHETER. THE SCRUB TECHNOLOGIST BELIEVES THAT THE VERY TORTUOUS NATURE OF THE VESSEL WAS CAUSING THE MICROCATHETER TO CINCH DOWN ON THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE TWO OTHER RUBY COILS THROUGH THE MICROCATHETER, RESISTANCE WAS FELT AND SUBSEQUENTLY, THE RUBY COILS WOULD NOT ADVANCE THROUGH THE MICROCATHETER; THEREFORE, THEY WERE REMOVED. IT WAS REPORTED THAT THE SCRUB TECHNOLOGIST INADVERTENTLY KINKED BOTH RUBY COILS AFTER REMOVING THEM FROM THE PACKAGING HOOP. THE PROCEDURE WAS COMPLETED USING A LANTERN DELIVERY MICROCATHETER AND TWO ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6535710 ↗
• MalfunctionMay 1, 2017Kinked; Failure to Advance; Physical Resistance; Kinked; Failure to Advance; 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 NON-PENUMBRA MICROCATHETER, THE SCRUB TECHNOLOGIST EXPERIENCED RESISTANCE AND THE RUBY COIL KEPT GETTING STUCK IN THE MICROCATHETER. THE SCRUB TECHNOLOGIST BELIEVES THAT THE VERY TORTUOUS NATURE OF THE VESSEL WAS CAUSING THE MICROCATHETER TO CINCH DOWN ON THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE TWO OTHER RUBY COILS THROUGH THE MICROCATHETER, RESISTANCE WAS FELT AND SUBSEQUENTLY, THE RUBY COILS WOULD NOT ADVANCE THROUGH THE MICROCATHETER; THEREFORE, THEY WERE REMOVED. IT WAS REPORTED THAT THE SCRUB TECHNOLOGIST INADVERTENTLY KINKED BOTH RUBY COILS AFTER REMOVING THEM FROM THE PACKAGING HOOP. THE PROCEDURE WAS COMPLETED USING A LANTERN DELIVERY MICROCATHETER AND TWO ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6535677 ↗
• MalfunctionFeb 3, 2017Failure to Advance; Failure to Advance

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF WAS UNABLE TO ADVANCE FOUR RUBY COILS PASS THEIR FRICTION LOCKS AND OUT OF THEIR INTRODUCER SHEATHS. THEREFORE, THE FOUR RUBY COILS WERE NOT USED FOR THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6301840 ↗
• MalfunctionDec 22, 2016Kinked; Device Damaged Prior to Use; Device Handling Problem; Kinked; Device Damaged Prior to Use; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE TECHNICIAN INADVERTENTLY KINKED A RUBY COIL WHILE REMOVING IT FROM THE PACKAGING. THE KINKED RUBY COIL WAS NOTICED 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 6198777 ↗
• MalfunctionDec 8, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH ANOTHER MANUFACTURER¿S MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE SAME MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE RUBY COIL WOULD NOT ADVANCE. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER MANUFACTURER¿S COILS AND THE SAME MICROCATHETER. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN A CONTINUOUS FLUSH DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6156933 ↗
• MalfunctionAug 10, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ADVANCING A RUBY COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED AND 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 Consequences Or Impact To Patient

  MAUDE report 5867166 ↗
• MalfunctionMay 18, 2016Kinked; Kinked

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED. THE PUSHER ASSEMBLY BECAME KINKED PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 5663235 ↗
• MalfunctionMay 11, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL OUT OF ITS ORANGE INTRODUCER SHEATH AND INTO ANOTHER MANUFACTURER'S MICROCATHETER. THE RUBY COIL WAS REMOVED AND 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 5648716 ↗
• MalfunctionMar 1, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH THE PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN FLUSHED AND REPOSITIONED THE PX SLIM; HOWEVER, THE RUBY COILS WERE STILL UNABLE TO ADVANCE THROUGH IT AND WERE REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NEW RUBY COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5472069 ↗
• MalfunctionFeb 25, 2016Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND DECIDED TO RETRACT IT IN ORDER TO REPOSITION THE TIP OF THE PX SLIM. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED IN THE PX SLIM. THE PHYSICIAN REMOVED THE PX SLIM FROM THE PATIENT AND PUSHED OUT THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5461654 ↗
• MalfunctionFeb 4, 2016Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A RUBY COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER AND INDICATED THAT THERE WAS TORTUOUSITY. THE RUBY COIL WAS REMOVED AND THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5411813 ↗
• MalfunctionJan 5, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ACCESSORY BRANCH FOR A FISTULA USING RUBY COILS. DURING THE PROCEDURE, WHILE IN USE WITH A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND ANOTHER MANUFACTURER'S DIAGNOSTIC CATHETER, THE PHYSICIAN PULLED BACK THE PX SLIM BEFORE THE RUBY COIL WAS FULLY ADVANCED OUT INTO THE TARGET VESSEL. SUBSEQUENTLY, THE RUBY COIL BECAME LODGED IN THE DIAGNOSTIC CATHETER AND THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY A SECOND RUBY COIL USING THE SAME PX SLIM; HOWEVER, THE SAME INCIDENT OCCURRED AND THE RUBY COIL BECAME LODGED IN THE DIAGNOSTIC CATHETER. THE PHYSICIAN REMOVED THE ENTIRE SYSTEM AND COMPLETED THE PROCEDURE USING ANOTHER MANUFACTURER'S STENT DEVICE. THERE WERE NO REPORTED ISSUES WITH THE PX SLIM AND THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5345760 ↗