Ruby XL Coil System RBYPODXL0655-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810169721711), received between Nov 13, 2025 and Jan 15, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Migration” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VARICES USING A POD XL, A NON-PENUMBRA COIL, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE NON-PENUMBRA COIL IN THE TARGET LOCATION. WHILE ADVANCING A POD XL, THE PHYSICIAN NOTICED THAT THE POD XL WAS TOO LARGE FOR THE TARGET VESSEL. WHILE RETRACTING THE POD XL, THE PHYSICIAN KINKED THE POD XL PUSHER ASSEMBLY. THE PHYSICIAN CONTINUED TO RETRACT THE POD XL AND NOTICED THAT THE POD XL UNRAVELED. THE POD XL WAS ABLE TO BE COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077400 ↗
• MalfunctionNov 13, 2025Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING POD XLS, A NON-PENUMBRA BRAIDED CATHETER, AND NON-PENUMBRA SHEATHS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD XL INTO THE TARGET LOCATION. WHILE RETRACTING THE CATHETER, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THE POD XL MOVED INTO AN ADJACENT ACCESSORY ARTERY. A SNARE DEVICE WAS USED TO REPOSITION THE POD XL BUT WAS UNSUCCESSFUL. WHILE RETRACTING THE SNARE DEVICE, THE POD XL BECAME DAMAGED. THE PHYSICIAN THEN DECIDED TO REMOVE THE EMBOLIZATION COIL USING THE SNARE. NO PART OF THE POD XL WAS LEFT IN THE PATIENT. THE PHYSICIAN THEN ADVANCED A NEW POD XL TO THE TARGET LOCATION AND ATTEMPTED TO DETACH THE COIL. HOWEVER, THE EMBOLIZATION COIL WAS STILL ATTACHED TO THE PUSHER ASSEMBLY. THE PHYSICIAN EXPERIENCED RESISTANCE REMOVING THE POD XL. THE POD XL WAS SUCCESSFULLY REMOVED. THE EMBOLIZATION COIL WAS DAMAGED UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA DEVICE, THE SAME BRAIDED CATHETER, AND THE SAME SHEATHS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544193 ↗