RUBY Coil RBY2C0410-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI M424RBY2C04100), received between Aug 20, 2015 and Nov 10, 2022 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2022Difficult to Advance; Migration; Premature Separation; Difficult to Advance; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE LANTERN, THE RUBY COIL WOULD NOT ADVANCE OR RETRACT. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN AND MIGRATED TO THE PROPER HEPATIC ARTERY. THE PHYSICIAN THEN ATTEMPTED TO SNARE THE RUBY COIL BUT WAS UNSUCCESSFUL. THE PHYSICIAN ABORTED THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776687 ↗
• MalfunctionFeb 26, 2021Material Deformation; Material Deformation

  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 ADVANCED A RUBY COIL INTO THE TARGET LOCATION BUT WAS NOT SATISFIED WITH THE POSITION AND DECIDED TO REMOVE THE RUBY COIL. UPON REMOVAL, THE RUBY COIL WAS DAMAGED. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL INTO THE TARGET LOCATION; HOWEVER, WAS NOT SATISFIED WITH THE POSITION AND DECIDED TO REMOVE THE RUBY COIL. UPON REMOVAL, THE RUBY COIL WAS DAMAGED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO FLUSH OR ADVANCE A GUIDEWIRE THROUGH THE LANTERN BECAUSE IT SEEMED LIKE THE LANTERN WAS BLOCKED. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A NEW 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 11388139 ↗
• MalfunctionJan 16, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LATERAL THORACIC ARTERY USING A POD3, RUBY COILS, NON-PENUMBRA DIAGNOSTIC CATHETER AND, LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD3 INTO THE TARGET VESSEL USING A LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD3 PUSHER ASSEMBLY BECAME BENT; THEREFORE, IT WAS REMOVED. NEXT, WHILE ADVANCING A RUBY COIL, THE PHYSICIAN WAS NOT SATISFIED OF THE LOCATION WHERE THE COIL HAD LANDED; THEREFORE, IT WAS REMOVED. WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE DIAGNOSTIC CATHETER AND BECAME STUCK. THEREFORE, THE LANTERN AND DIAGNOSTIC CATHETER WERE REMOVED CONTAINING THE DETACHED RUBY COIL. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL USING THE SAME LANTERN AND DIAGNOSTIC CATHETER. HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN WAS MORE AGGRESSIVE WITH THE RUBY COIL AND THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, THE SAME LANTERN AND DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596909 ↗
• MalfunctionApr 17, 2019Malposition of Device; Premature Separation; Malposition of Device; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN MULTIPLE GASTRIC VESSELS USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED ELEVEN RUBY COILS INTO THE TARGET VESSELS USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING THE LAST RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL TO RE-POSITION IT AND NOTICED THAT IT HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE RUBY COIL HAD DETACHED PARTIALLY IN THE VESSEL AND PARTIALLY WITHIN THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE REMAINING PART OF THE RUBY COIL OUT OF THE MICROCATHETER AND INTO THE VESSEL USING THE DETACHED DELIVERY PUSHER. THE RUBY COIL WAS IMPLANTED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524549 ↗
• MalfunctionFeb 21, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPRADUODENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO RUBY COILS INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). AFTER ADVANCING THE THIRD RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN DECIDED TO REPOSITION THE RUBY COIL WITHIN THE VESSEL AND REPORTED FEELING RESISTANCE WHILE ADVANCING. THE PHYSICIAN THEN ADVANCED THE NON-PENUMBRA DIAGNOSTIC CATHETER FURTHER OVER THE LANTERN TO GAIN ADDITIONAL SUPPORT, AND RETRACTED THE RUBY COIL BACK INTO THE LANTERN, IN PREPARATION TO DETACH THE RUBY COIL. HOWEVER, IT WAS REPORTED THAT WHILE RETRACTING THE RUBY COIL BACK INTO THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN WAS ABLE TO PUSH THE REMAINING 1 CM OF THE RUBY COIL OUT OF THE LANTERN INTO THE VESSEL USING THE COIL'S PUSHER ASSEMBLY. THE LANTERN WAS THEN FLUSHED, AND THE PROCEDURE WAS 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 8357426 ↗
• MalfunctionAug 8, 2018Premature Activation; Physical Resistance/Sticking; Premature Activation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SOMEWHAT TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. HOWEVER, WHILE RE-SHEATHING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL AND THE COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7764693 ↗
• MalfunctionApr 11, 2018Break; Fracture; Physical Resistance; Break; Fracture; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEEDING (GI BLEED) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A RUBY COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV) OF A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME DETACHED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 7421481 ↗
• MalfunctionMar 14, 2018Device Contamination with Body Fluid; Physical Resistance; Device Contamination with Body Fluid; 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 7337704 ↗
• MalfunctionDec 19, 2017Split; Physical Resistance; Split; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, AND REPORTED THAT UNDER FLUOROSCOPY IT APPEARED THAT THE RUBY COIL DISTAL END WAS SPLIT. THEREFORE, THE MICROCATHETER WAS REMOVED WITH THE RUBY COIL INSIDE. THE PROCEDURE WAS THEN 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 7131738 ↗
• MalfunctionOct 23, 2017Positioning Failure; Failure to Fold; Device Operates Differently Than Expected; Positioning Failure; Failure to Fold; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO IMPLANT TWO RUBY COILS IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THAT THE COILS WERE NOT TAKING THEIR INTENDED SHAPE; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 6969069 ↗
• MalfunctionAug 18, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED FIVE RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, IT WAS REMOVED INTACT. THE PROCEDURE WAS THEN COMPLETED USING THREE ADDITIONAL RUBY COILS AND THE SAME LANTERN. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT USE A CONTINUOUS FLUSH THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6806039 ↗
• InjurySep 20, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE BRONCHIAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING AND DEPLOYING A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL IN ORDER TO REPOSITION IT. HOWEVER, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN NOTICED THE RUBY COIL HAD UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY INSIDE THE PATIENT'S BODY. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL FROM THE PATIENT'S BODY USING A SNARE DEVICE BUT WAS UNSUCCESSFUL. THE RUBY COIL WAS LEFT IN THE PATIENT'S BODY, PROXIMAL TO THE ANEURYSM. NEXT,THE PHYSICIAN ADVANCED AND DEPLOYED A NEW RUBY COIL IN THE TARGET VESSEL USING THE LANTERN. HOWEVER, WHILE ATTEMPTING TO RETRACT THE RUBY COIL IN ORDER TO REPOSITION IT, THE PHYSICIAN NOTICED THE RUBY COIL HAD UNINTENTIONALLY DETACHED. PART OF THE DETACHED RUBY COIL WAS ALREADY INSIDE THE ANEURYSM EXCEPT THE TAIL. THE PHYSICIAN THEN ATTEMPTED TO SNARE IT BUT WAS UNSUCCESSFUL; THEREFORE THE DETACHED RUBY COIL WAS LEFT IN THE PATIENT. THEREAFTER, THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SAME LANTERN. THE PHYSICIAN MAINTAINED CONTINUOUS FLUSH THROUGH TH

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 5963679 ↗
• MalfunctionMar 30, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL FAILED TO DETACH IN THE ANEURYSM AND WAS REMOVED FROM THE PATIENT. WHILE ADVANCING A NEW RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE RUBY COIL'S PUSHER ASSEMBLY BECAME KINKED AND IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5536490 ↗
• MalfunctionOct 1, 2015Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL. PRIOR TO INTERACTION WITH THE PATIENT, THE RUBY COIL PUSHER WIRE BROKE WHILE BEING PUSHED. THE PHYSICIAN DECIDED THAT ANOTHER COIL WAS NOT NEEDED AND ENDED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5117916 ↗
• MalfunctionAug 20, 2015Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. UPON REMOVAL FROM THE PACKAGING, THREE RUBY COILS BECAME KINKED AND WERE NOT USED IN THE PROCEDURE. THE PROCEDURE SUCCESSFULLY CONTINUED USING ANOTHER MANUFACTURER'S DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 5019532 ↗