Ruby XL Coil System RBYPCXL45-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810169721575), received between Aug 29, 2025 and Sep 22, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Premature Separation

  The patient was undergoing a coil embolization procedure in the gastric varices using a Packing Coil XL, Ruby XL, and a non-Penumbra diagnostic catheter. While advancing a Packing Coil XL to the target location, the physician encountered resistance. Upon retraction, the embolization coil unintentionally detached within the diagnostic catheter. The physician subsequently used saline to flush the detached Packing Coil XL into the vessel.While advancing the a Ruby XL, resistance was encountered again. The Ruby XL was retracted and it unintentionally detached within the diagnostic catheter. The physician subsequently used saline to flush the detached Ruby XL into the vessel.The procedure was completed using a new non-Penumbra coil and the same diagnostic catheter. There was no report of an adverse effect to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852399 ↗
• MalfunctionApr 16, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A NON-PENUMBRA SHEATH (7F X 45CM), A NON-PENUMBRA CATHETER (4F X 135CM), AND A GLIDEWIRE. WHILE ADVANCING A POD XL THROUGH THE CATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER AFTER ADVANCING MORE THAN HALFWAY. THE DETACHED EMBOLIZATION COIL WAS PUSHED INTO THE TARGET LOCATION USING THE GLIDEWIRE. FIVE NON-PENUMBRA COILS WERE THEN PLACED INTO THE TARGET VESSEL. THE PHYSICIAN DECIDED TO USE A PACKING COIL XL. WHILE ADVANCING THE PACKING COIL XL THROUGH THE CATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER AFTER ADVANCING APPROXIMATELY HALFWAY. THE DETACHED EMBOLIZATION COIL WAS PUSHED OUT OF THE CATHETER USING THE GLIDEWIRE, PROXIMAL TO THE TARGET VESSEL. IT WAS REPORTED THAT THE CATHETER WAS FLUSHED BETWEEN COIL PLACEMENT. THE PROCEDURE WAS COMPLETED USING NON-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 24894702 ↗
• MalfunctionOct 30, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN AN ABDOMINAL AORTIC ANEURYSM (AAA) USING A PACKING COIL XL AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PACKING COIL XL TO THE TARGET LOCATION. THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL XL. WHILE REMOVING THE COIL, THE PUSHER ASSEMBLY KINKED AND FRACTURED, CAUSING THE PACKING COIL XL TO DETACH INSIDE THE CATHETER. A SNARE DEVICE WAS USED TO REMOVE THE DETACHED PACKING COIL XL FROM THE CATHETER. IT WAS NOTED THAT THE PACKING COIL XL WAS UNRAVELED WHEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW PACKING COIL 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 23423142 ↗
• MalfunctionSep 5, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE INTERNAL ILIAC ARTERY PROCEDURE USING A PACKING COIL XL AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE POD XL INTO THE TARGET LOCATION. WHILE ATTEMPTING TO PLACE THE PACKING COIL XL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED. THE CATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED AT THIS POINT AS THE PHYSICIAN LIKED THE POD XL PLACEMENT IN THE TARGET LOCATION. THE PHYSICIAN THEN STENTED THE INTERNAL ILIAC ARTERY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983709 ↗
• InjuryAug 29, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAIN RENAL ARTERY USING PACKING COIL XLS, A NON-PENUMBRA NON-BRAIDED CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PACKING COIL XL IN THE TARGET LOCATION. WHILE ADVANCING A THIRD PACKING COIL XL THROUGH THE MICROCATHETER, THE THIRD PACKING COIL XL UNINTENTIONALLY DETACHED. THE PHYSICIAN USED A SYRINGE TO PUSH THE DETACHED PACKING COIL XL OUT OF THE MICROCATHETER. IT WAS NOTED THAT SOME OF THE DETACHED PACKING COIL XL WAS IN THE TARGET LOCATION. THE PHYSICIAN THEN PUSHED THE DETACHED PACKING COIL XL INTO A BRANCH OF THE MAIN RENAL ARTERY WITH A STENT. THE PROCEDURE WAS COMPLETED AFTER STENTING THE MAIN RENAL ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22929422 ↗