RUBY Coil RBY2C0725-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814548018836), received between Nov 26, 2019 and Jul 1, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Fold” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2021Device Dislodged or Dislocated; Migration; Physical Resistance/Sticking; Device Dislodged or Dislocated; Migration; Physical Resistance/Sticking

  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 12097699 ↗
• MalfunctionJun 21, 2021Premature Separation; Premature Separation

  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 ADVANCING THE RUBY COIL TO THE TARGET VESSEL USING THE LANTERN, THE PHYSICIAN NOTICED THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE DETACHED RUBY COIL PARTIALLY BEYOND THE TIP OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, A POD COIL, 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 12037403 ↗
• MalfunctionAug 28, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, A RUBY COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL INTO THE TARGET LOCATION USING THE LANTERN; HOWEVER, THE POD6 COIL WOULD NOT TAKE ITS INTENDED SHAPE OR WOULD MIGRATE DISTALLY. THEREFORE, THE POD6 COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED A POD5 COIL INTO THE TARGET LOCATION USING THE LANTERN; HOWEVER, THE POD COIL WOULD NOT TAKE ITS INTENDED SHAPE OR WOULD MIGRATE DISTALLY. THEREFORE, THE POD5 COIL WAS REMOVED. THEN, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A POD6 COIL 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 10466835 ↗
• MalfunctionNov 26, 2019Failure to Fold; Physical Resistance/Sticking; Failure to Fold; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL TO THE TARGET VESSEL, AND IT WAS NOT SHAPING; SUBSEQUENTLY, THE PHYSICIAN DECIDED TO RE-SHEATH THE RUBY COIL AND TRY ANOTHER SIZE. WHILE RE-SHEATHING THE RUBY COIL, THE RUBY COIL BECAME STUCK AND WOULD NOT RE-SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED UNSHEATHED. IT WAS REPORTED THAT THE PUSHER ASSEMBLY OF THE RUBY COIL WAS STUCK INSIDE ITS SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9377075 ↗