Ruby XL Coil System RBYPCXL70-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810169721599), received between Oct 27, 2025 and May 13, 2026 — classified as 4 malfunctions.

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

• MalfunctionMay 13, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GASTRIC VARICES USING A PACKING COIL XL, A NON-PENUMBRA CATHETER. WHILE ADVANCING A PACKING COIL XL THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE PUSHING THROUGH THE RESISTANCE, THE PACKING COIL XL PUSHER ASSEMBLY KINKED THEN FRACTURED. THIS CAUSED THE EMBOLIZATION COIL TO DETACH PARTIALLY WITHIN THE CATHETER AND THE TARGET VESSEL. THE PHYSICIAN ADVANCED A GUIDEWIRE (.035) TO PUSH THE REMAINING DETACHED EMBOLIZATION COIL INTO THE TARGET LOCATION. AFTER RETRACTING THE CATHETER, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE TAIL END OF THE PACKING COIL XL WAS FLOWING INTO THE SPLENIC VEIN. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE EMBOLIZATION COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH PACKING COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159347 ↗
• MalfunctionMar 20, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GONADAL VEIN USING RUBY COILS, RUBY COIL XLS, A PACKING COIL XL, AND A NON-PENUMBRA CATHETER. THE PHYSICIAN PLACED RUBY COILS AND RUBY COIL XLS IN THE TARGET LOCATION. THE CATHETER WAS THEN FLUSHED. WHILE ADVANCING A PACKING COIL XL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE EMBOLIZATION COIL WOULD NOT FORM AND PACK IN THE VESSEL. AFTER MAKING SEVERAL ATTEMPTS TO ADVANCE AND FORM THE COIL IN THE VESSEL, THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL XL. WHILE RETRACTING THE PACKING COIL XL, THE EMBOLIZATION COIL HAD UNINTENTIONALLY DETACHED WITHIN THE CATHETER WITH THE DISTAL END OF THE COIL STICKING OUT INTO THE VESSEL. THE CATHETER CONTAINING THE DETACHED PACKING COIL XL WAS REMOVED AND THE COIL WAS FLUSHED OUT FROM THE CATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COIL XLS, A POD XL, AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650989 ↗
• MalfunctionJan 9, 2026Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A ESOPHAGEAL VARICES AND SPLENIC RENAL SHUNT USING A PACKING COIL XLS AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE PACKING COIL XLS INTO THE TARGET VESSEL. IT WAS NOTED THAT THE PHYSICIAN FLUSHED THE CATHETER BETWEEN EACH COIL. WHILE ADVANCING A NEW PACKING COIL XL, THE COIL WOULD NOT EXIT THE CATHETER. THE PHYSICIAN FLUSHED THE CATHETER AND ATTEMPTED TO RE-ADVANCE THE PACKING COIL XL TWICE WITHOUT SUCCESS. WHILE RE-ADVANCING A THIRD TIME, THE PHYSICIAN KINKED THE PACKING COIL XL PUSHER ASSEMBLY AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THE CATHETER CONTAINING THE EMBOLIZATION COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL PENUMBRA COILS AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028500 ↗
• MalfunctionOct 27, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE OVARIAN VEIN PROCEDURE USING A PACKING COIL XL, A NON-PENUMBRA CATHETER (4F GLIDECATH), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A PACKING COIL XL THROUGH THE GLIDE CATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED INSIDE THE CATHETER. THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE DETACHED EMBOLIZATION COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393809 ↗