RUBY Coil RBY2C0305-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI M424RBY2C03050), received between Aug 26, 2015 and Sep 26, 2019 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2019Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HEPATIC ARTERY USING A RUBY COIL. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DECIDED TO RETRACT IT FOR REPOSITIONING. HOWEVER, WHILE RETRACTING THE RUBY COIL, NO RESISTANCE WAS EXPERIENCED AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE PATIENT. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. WHILE RETRACTING, THE RUBY COIL BEGAN TO UNRAVEL. IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PULLED AND REMOVED THE ENTIRE RUBY COIL FROM THE PATIENT. 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 Consequences Or Impact To Patient

  MAUDE report 9126506 ↗
• InjurySep 24, 2019Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL MAMMARY ARTERIES (RIMA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIAL COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). AFTER PLACING THE LAST RUBY COIL, THE LANTERN WAS REMOVED AND THE FINAL ANGIOGRAPHY SHOWED THAT THE RUBY COIL WAS UNRAVELING OUT OF THE RIMA; THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO PACK THE PROXIMAL PORTION OF THE RIMA WITH A POD PACKING COIL (PODJ) USING THE SAME LANTERN; HOWEVER, THE PODJ WAS OVERSIZED AND WAS THEREFORE, REMOVED INTACT. THE PROCEDURE ENDED AT THIS POINT AND NO ADDITIONAL COIL WAS PLACED TO PACK THE PROXIMAL CAP OF THE RIMA. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112584 ↗
• MalfunctionSep 10, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN RESUMED THE PROCEDURE AND SUCCESSFULLY PLACED ANOTHER RUBY COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A SMART COIL WHICH ¿WOULD NOT COIL;¿ THEREFORE, IT WAS REMOVED. THE PHYSICIAN RESUMED THE PROCEDURE AGAIN AND SUCCESSFULLY PLACED ANOTHER SMART COIL. THE PROCEDURE WAS CONTINUED AND COMPLETED USING PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8984789 ↗
• MalfunctionAug 6, 2019Failure 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 A NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COILS AND THE MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER PUSHABLE COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866275 ↗
• MalfunctionFeb 13, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH A RUBY COIL USING A HANDLE AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL 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 8338171 ↗
• MalfunctionMay 8, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH THE RUBY COIL, DESPITE THE PET LOCK BEING BROKEN AFTER USING THE HANDLE. THE RUBY COIL WAS THEREFORE REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL 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 7495254 ↗
• MalfunctionMar 7, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO RUBY COILS IN THE GASTRODUODENAL ARTERY (GDA) USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO PLACE TWO OTHER RUBY COILS IN THE RIGHT GASTRIC ARTERY WITH A VERY TIGHT TURN, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN THE COILS REACHED THE DISTAL END OF THE MICROCATHETER AND SUBSEQUENTLY, THE RUBY COILS WOULD NOT ADVANCE FURTHER. THEREFORE, THE RUBY COILS WERE REMOVED AND THE PHYSICIAN DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321718 ↗
• MalfunctionJul 20, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE RUBY COIL FULLY THROUGH THE INTRODUCER SHEATH AND INTO THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COIL WAS 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 6728402 ↗
• InjuryJun 23, 2017Detachment Of Device Component; Positioning Failure; Detachment Of Device Component; Positioning Failure

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED INITIAL RUBY COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN DID NOT MENTION ANY RESISTANCE; HOWEVER, THE COIL UNINTENTIONALLY DETACHED WHILE PARTIALLY INSIDE THE VESSEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. NEXT, WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN DID NOT MENTION ANY RESISTANCE; HOWEVER, THE COIL WAS UNABLE TO COMPLETELY ADVANCE OUT OF THE TIP OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED AND IT WAS NOTED THAT THE PUSHER ASSEMBLY APPEARED TO BE BENT. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING ADDITIONAL COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6663354 ↗
• MalfunctionApr 21, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN DID NOT MENTION ANY RESISTANCE BUT WAS UNABLE TO ADVANCE THE COIL THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL 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 6512533 ↗
• MalfunctionApr 3, 2017Entrapment of Device; Stretched; Entrapment of Device; Stretched

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPO GASTRIC ARTERY USING POD PACKING COILS (PODJ COILS) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PODJ IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, THE PODJ COIL WAS TOO LONG FOR THE ANEURYSM AND THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. WHILE REMOVING THE LANTERN AND THE PODJ COIL ALTOGETHER, PART OF THE PODJ COIL WAS OUT OF THE TIP OF THE LANTERN AND GOT CAUGHT WITH THE BASE CATHETER; SUBSEQUENTLY THE PODJ STRETCHED AFTER REMOVAL. THE LANTERN WAS THEN FLUSHED AND RE-INSERTED INTO THE PATIENT¿S BODY. WHILE USING A RUBY COIL WITH THE LANTERN, THE PHYSICIAN LOST ACCESS TO THE TARGET VESSEL AND DECIDED TO REMOVE THE LANTERN AND THE RUBY COIL ALTOGETHER. HOWEVER, WHILE RETRACTING THE LANTERN, PART OF THE RUBY COIL WAS OUT OF THE TIP OF THE LANTERN AND GOT CAUGHT WITH THE BASE CATHETER AND SUBSEQUENTLY, THE RUBY COIL BECAME STRETCHED AFTER REMOVAL. NEXT, THE PHYSICIAN FLUSHED THE LANTERN AND RE-INSERTED IT INTO THE PATIENT¿S BODY. WHILE USING A NEW RUBY COIL WITH THE LANTERN, THE PHYSICIAN LOSS ACCESS IN THE TARGET VESSEL AGAIN AND DECIDED TO WITHDRAW THE RUBY C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6455075 ↗
• MalfunctionMar 17, 2017Break; Kinked; Material Separation; Break; Kinked; Material Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE 2 ENDOLEAK USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DID NOT MENTION EXPERIENCING ANY RESISTANCE; HOWEVER, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED. UPON REMOVAL OF THE RUBY COIL, THE PUSHER ASSEMBLY BROKE IN HALF. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE SAME LANTERN BUT ENCOUNTERED RESISTANCE AFTER ABOUT HALF OF THE COIL WAS ADVANCED INTO THE PATIENT. THE PHYSICIAN THEN DECIDED TO REMOVE THE RUBY COIL, FLUSH AND REPOSITION THE LANTERN. NEXT, THE PHYSICIAN MADE ANOTHER ATTEMPT TO ADVANCE THE SAME RUBY COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE ENDED WITHOUT COILING THE ENDOLEAK. THE PATIENT IS EXPECTED TO RETURN TO THE HOSPITAL ON A DIFFERENT DATE TO COMPLETE THE PROCEDURE BECAUSE THE LENGTH OF PROCEDURE TIME TO GAIN ACCESS CAUSED HIGH FLUORO EXPOSURE AS WELL AS HIGH CONTRAST. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6412304 ↗
• MalfunctionFeb 6, 2017Stretched; Device Operates Differently Than Expected; Stretched; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE ANEURYSM; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THE RUBY COIL WAS FILLING THE ANEURYSM; THEREFORE, IT WAS REMOVED. THE HOSPITAL STAFF WAS UNABLE TO RE-SHEATH THE RUBY COIL INTO THE INTRODUCER SHEATH AND NOTICED THAT THE RUBY COIL LOOKED SLIGHTLY STRETCHED. THE PROCEDURE WAS COMPLETED USING THE SAME NON-PENUMBRA MICROCATHETER AND NEW RUBY COILS. IT SHOULD BE NOTED THAT THE PHYSICIAN REPORTED MAINTAINING CONTINUOUS FLUSH AND USING A ROTATING HEMOSTASIS VALVE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6306088 ↗
• MalfunctionOct 12, 2016Bent; Physical Resistance; Device Handling Problem; Bent; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT TWO PULMONARY ARTERIOVENOUS MALFORMATIONS (AVM'S) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL INTO ONE OF THE VESSELS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN WANTED TO TREAT ANOTHER BRANCH USING A NEW RUBY COIL. HOWEVER, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND INADVERTENTLY BENT THE RUBY COIL PUSHER ASSEMBLY. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MAINTAINED 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 6023381 ↗
• MalfunctionJun 22, 2016Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED RUBY COILS INTO THE TARGET VESSEL USING A RUBY COIL DETACHMENT HANDLE (HANDLE). AFTER DEPLOYING A NEW RUBY COIL INTO THE PATIENT, THE PHYSICIAN USED THE SAME HANDLE TO DETACH THE COIL. HOWEVER, UPON REMOVAL OF THE RUBY COIL PUSHER ASSEMBLY FROM THE HANDLE, THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS STILL ATTACHED TO THE PUSHER ASSEMBLY AND DID NOT ATTACH IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL 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 5743381 ↗
• MalfunctionMar 22, 2016Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL CAROTID ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED AN INITIAL RUBY COIL INTO THE ANEURYSM. THE PHYSICIAN THEN DEPLOYED A NEW RUBY COIL INTO THE ANEURYSM BUT WAS UNABLE TO DETACH THIS COIL. THEREFORE, THE RUBY COIL WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS STOPPED AT THIS POINT WITHOUT ANY ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5515986 ↗
• MalfunctionAug 26, 2015Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH ANOTHER MANUFACTURER'S CATHETER AND WAS REMOVED. UPON REMOVAL FROM THE MICROCATHETER, THE PUSHERWIRE OF THE RUBY COIL BECAME KINKED AND IT WAS NOT USED AGAIN. THE PROCEDURE CONTINUED USING A NEW RUBY COIL; HOWEVER, THE RESISTANCE WAS MET WHILE ADVANCING THROUGH THE CATHETER. UPON WITHDRAWAL, THE RUBY COIL BECAME STUCK INSIDE THE MICROCATHETER AND IT UNINTENTIONALLY DETACHED. THE PHYSICIAN SUCCESSFULLY REMOVED THE MICROCATHETER WITH THE DETACHED RUBY COIL INSIDE. UPON REMOVAL, THE PHYSICIAN NOTED THAT THE WRONG SIZED MICROCATHETER WAS BEING USED. THE PROCEDURE SUCCESSFULLY CONTINUED USING ANOTHER MANUFACTURER'S MICROCATHETER AND COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5033523 ↗