RUBY Coil RBY2C0620-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00814548018805), received between Jul 27, 2018 and Jul 1, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2021Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING RUBY COILS, LANTERN DELIVERY MICROCATHETERS (LANTERN), A NON-PENUMBRA SHEATH, AND A 4F GLIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED TWO RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN; HOWEVER, BOTH COILS WERE DETERMINED TO BE OVERSIZED. THEREFORE, BOTH RUBY COILS WERE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE. UPON FURTHER INSPECTION, THE PHYSICIAN NOTICED A KINK TOWARDS THE HUB OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED AND SAVED FOR LATER USE. THE PHYSICIAN THEN REMOVED THE DAMAGED LANTERN AND INSERTED A NEW LANTERN INTO THE PATIENT. AFTERWARDS, THE PHYSICIAN IMPLANTED THE PREVIOUSLY REMOVED RUBY COIL IN THE TARGET VESSEL. WHILE ADVANCING A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO IMPLANT THE RUBY COIL IN THE TARGET VESSEL. SUBSEQUENTLY, WHEN THE SCRUB TECHNOLOGIST WAS RETRACTING THE LANTERN WITHOUT A GUIDEWIRE, BOTH RUBY COILS WERE PULLED BACK INTO THE BRACHIAL ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE BOTH RUBY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097695 ↗
• MalfunctionMay 17, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GONADAL VEIN USING A RUBY COIL. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE THE RUBY COIL WITHIN ITS INTRODUCER SHEATH ON THE BACK TABLE; HOWEVER, THE RUBY COIL WOULD STILL NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11836542 ↗
• MalfunctionMay 17, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COILS WOULD NOT ADVANCE OUT FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, BOTH RUBY COILS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832698 ↗
• MalfunctionMay 17, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COILS WOULD NOT ADVANCE OUT FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, BOTH RUBY COILS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832692 ↗
• MalfunctionApr 27, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD PACKING COILS (POC PCS), A RUBY COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD PC INTO THE ANEURYSM; HOWEVER, THE POD PC WOULD NOT ANCHOR AND CONSEQUENTLY, THE LANTERN KICKED OUT OF THE VESSEL. THEREFORE, THE POD PC WAS REMOVED. THE PHYSICIAN THEN ADVANCED A RUBY COIL INTO THE TARGET LOCATION; HOWEVER, THE SAME ISSUE OCCURRED. THE RUBY COIL WOULD NOT ANCHOR; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 11733652 ↗
• MalfunctionAug 13, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH A RUBY COIL USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS 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 10405002 ↗
• MalfunctionJul 10, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT HAD HIGH FLOW VESSELS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THREE RUBY COILS INDIVIDUALLY TO THE TARGET VESSEL AND ATTEMPTED TO FORM EACH RUBY COIL. HOWEVER, THE RUBY COILS WOULD NOT FORM AND WERE RE-SHEATHED. AFTER BEING RE-SHEATHED, TWO OF THE RUBY COILS WERE UNABLE TO ADVANCE OUT OF THEIR INTRODUCER SHEATHS. THE PHYSICIAN THEN RE-ADVANCED THE THIRD RUBY COIL, AND WHILE PLACING THE RUBY COIL IN THE TARGET VESSEL, THE RUBY COIL FORMED APPROXIMATELY 70% BUT FLOWED BACK ACROSS THE SPLENIC ARTERY AND PAST THE CELIAC TRUNK. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO RE-SHEATH THE RUBY COIL AGAIN; HOWEVER, IT UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE SPLENIC ARTERY. THEREFORE, THE PHYSICIAN FLUSHED THE REMAINING COIL OUT OF THE MICROCATHETER AND INTO THE VESSEL. NO ATTEMPT WAS MADE TO REMOVE THE DETACHED RUBY COIL. 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 10261130 ↗
• MalfunctionJul 27, 2018Deformation Due to Compressive Stress; Inadequate User Interface; Deformation Due to Compressive Stress; Inadequate User Interface

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO A LANTERN, THE HOSPITAL TECHNOLOGIST KINKED THE RUBY COIL PUSHER ASSEMBLY; THEREFORE, IT WAS REMOVED. UPON REMOVING THE RUBY COIL, THE HOSPITAL TECHNOLOGIST INADVERTENTLY KINKED THE LANTERN THAT WAS BEING USED. THE PROCEDURE WAS COMPLETED USING A NEW 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 7729130 ↗