Ruby XL Coil System RBYPODXL0855-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810169721728), received between Mar 26, 2026 and Jun 2, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 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 25368249 ↗
• MalfunctionMay 13, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL, RUBY COIL, POD XL COIL (POD XL), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA DIAGNOSTIC CATHETER. IT WAS NOTED THAT THE TARGET VESSEL WAS LOCATED ON A BEND WITHIN THE SPLENIC ARTERY. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE POD COIL AND ONE RUBY COIL IN THE TARGET VESSEL. WHILE ADVANCING A POD XL OUT OF THE DIAGNOSTIC CATHETER, RESISTANCE WAS FELT. THE EMBOLIZATION COIL WOULD NOT FORM WITHIN THE VESSEL. WHILE TORQUING THE 5FR DIAGNOSTIC CATHETER AND THE POD XL, THE PHYSICIAN NOTICED THE POD XL WAS NOT RESPONDING TO MOVEMENT. THE EMBOLIZATION COIL FRACTURED BUT WAS STILL CONNECTED TO IT¿S PUSHER ASSEMBLY. MAJORITY OF THE COIL REMAINED WITHIN THE 5F CATHETER. IT WAS REPORTED THAT THE ENTIRE POD XL WAS REMOVED FROM THE PATIENT BY HAND. THE PROCEDURE WAS COMPLETED WITH A NEW POD XL 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 25160940 ↗
• MalfunctionMar 26, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING A POD XL COIL (POD XL), A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH (6FR) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED ACCESS FROM THE LEFT GROIN AND ADVANCED THE GUIDEWIRE AND CATHETER THROUGH THE SHEATH. WHILE ATTEMPTING TO ADVANCE THE POD XL, THE PHYSICIAN REPORTED DIFFICULTY ADVANCING THE POD XL DUE TO VESSEL TORTUOSITY AND THE TURN FROM THE AORTA INTO THE TARGET ARTERY. UNDER FLUOROSCOPY, THE PHYSICIAN NOTICED THAT THE POD XL HAD UNINTENTIONALLY DETACHED, WITH A SMALL PART OF THE COIL REMAINING WITHIN THE CATHETER. WHILE ATTEMPTING TO REMOVE THE CATHETER, SOME PART OF THE COIL WAS PULLED INTO THE AORTA. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE POD XL. AFTER THE POD XL WAS REMOVED, THE PHYSICIAN PROCEEDED BY DOWNSIZING TO A RUBY COIL, AND PACKING COILS USING A LANTERN DELIVERY MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702169 ↗