Ruby XL Coil System RBYPCXL30-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810169721568), received between Aug 13, 2025 and Jun 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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.

• MalfunctionJun 2, 2026Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING A PACKING COIL XL, A POD XL AND A NON- PENUMBRA CATHETER (5FR). IT WAS REPORTED THAT THE COILS WOULD NOT STAY AT THE INTENDED LOCATION AND MIGRATED TO ANOTHER BRANCH OF THE PULMONARY ARTERY. THE PHYSICIAN REMOVED BOTH COILS USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING RUBY 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 25368247 ↗
• MalfunctionDec 18, 2025Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL ILIAC ARTERY USING A PACKING COIL XL AND A NON-PENUMBRA ANGLED DIAGNOSTIC CATHETER. WHILE REPOSITIONING THE PACKING COIL XL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PACKING COIL XL COULD NOT ADVANCE OR RETRACT. WHILE REMOVING THE PACKING COIL XL, IT BECAME DAMAGED BUT REMAINED INTACT TO ITS PUSHER ASSEMBLY. THE PHYSICIAN CONTINUED TO PULL THE PACKING COIL XL WITH FORCE AND KINKED THE PUSHER ASSEMBLY CAUSING THE EMBOLIZATION COIL TO DETACH OUTSIDE OF THE CATHETER. THE EMBOLIZATION COIL COULD NOT BE RETRACTED FROM THE CATHETER AND WAS REMOVED USING A SNARE DEVICE. NO MATERIAL OF THE EMBOLIZATION COIL WAS LEFT IN THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED USING A RUBY COIL AND A MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846313 ↗
• MalfunctionNov 18, 2025Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT MAIN PULMONARY TRUNK USING POD COILS, A POD PACKING COIL (PACKING COIL), PACKING COIL XLS, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED EIGHT POD COILS, ONE PACKING COIL, AND THREE PACKING COIL XLS IN THE TARGET LOCATION. AFTER PLACING A FINAL PACKING COIL IN THE TARGET LOCATION, THE PHYSICIAN PERFORMED A FLUOROSCOPY AND NOTICED THE COILS PLACED IN THE TARGET SITE HAD SHIFTED. IT WAS REPORTED THE TAIL END OF THE 30CM PACKING COIL XL HAD COME OUT OF THE TARGET LOCATION AND WAS IN AN ADJACENT PULMONARY TRUNK THAT WAS MEDIAL AND LATERAL TO THE TARGET SITE. THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE 30CM PACKING COIL XL. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587338 ↗
• MalfunctionAug 13, 2025Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PACKING COIL XL AND A NON-PENUMBRA GLIDE CATHETER (4F). IT WAS REPORTED THAT THE TARGET VESSEL WAS A HIGH FLOW AREA. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO PACKING COIL XLS IN THE TARGET VESSEL USING THE GLIDE CATHETER. AFTER REMOVING THE GLIDE CATHETER, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE PREVIOUSLY PLACED PACKING COIL XL MIGRATED FROM THE SPLENIC ARTERY TO THE HEPATIC ARTERY. A SNARE DEVICE WAS USED TO REMOVE THE PACKING COIL XL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A RUBY COIL, A POD PACKING COIL (PACKING COIL), AND A MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794567 ↗