Ruby XL Coil System RBYPCXL55-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810169721582), received between Nov 26, 2025 and Apr 29, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING A PACKING COIL XL AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PACKING COIL XL INTO THE TARGET ARTERY. WHILE MANIPULATING THE PACKING COIL XL FOR PLACEMENT, THE COIL APPEARED TO DETACH FROM THE PUSHER ASSEMBLY. UPON REMOVAL OF THE PUSHER ASSEMBLY, IT WAS NOTICED THAT THE PACKING COIL XL REMAINED ATTACHED, AND THE COIL BEGAN TO UNRAVEL. IT WAS REPORTED THAT THE PACKING COIL XL WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL 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 25035441 ↗
• MalfunctionApr 29, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A LARGE GASTRIC VARICES FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) USING A PACKING COIL XL AND A NON-PENUMBRA CATHETER. AFTER ADVANCING A PACKING COIL XL INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT IT TO REPOSITION THE EMBOLIZATION COIL. WHILE RETRACTING THE PUSHER ASSEMBLY, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PACKING COIL XL HAD UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THEREFORE, THE CATHETER CONTAINING THE DETACHED PACKING COIL XL WAS REMOVED AND THE EMBOLIZATION COIL WAS FLUSHED OUT. THE PHYSICIAN REGAINED ACCESS TO THE VESSEL USING THE SAME CATHETER. THE PROCEDURE WAS COMPLETED USING NEW RUBY XLS 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 25026741 ↗
• MalfunctionMar 11, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A COLLATERAL VESSEL USING A PACKING COIL XL, POD PACKING COILS (PACKING COILS), AND A NON-PENUMBRA CATHETER (4F). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL XL INTO THE VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE RETRACTING THE PACKING COIL XL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THE CATHETER CONTAINING THE EMBOLIZATION COIL WAS REMOVED. THE PHYSICIAN OPENED A LANTERN DELIVERY MICROCATHETER (LANTERN) AND ADVANCED A PACKING COIL INTO THE TARGET VESSEL. WHILE REPOSITIONING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE VESSEL. A SNARE DEVICE WAS USED TO REMOVE THE DETACHED EMBOLIZATION COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW PACKING COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574542 ↗
• MalfunctionJan 6, 2026Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GASTRIC VARICES USING A PACKING COIL XL, A POD XL, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE POD XL AND ONE PACKING COIL XL IN THE TARGET LOCATION. AFTER CONTRAST INJECTION, THE PHYSICIAN NOTICED THAT THE PREVIOUSLY PLACED PACKING COIL XL MIGRATED TO THE HEPATIC VEIN. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE PACKING COIL XL. 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 23985736 ↗
• MalfunctionDec 30, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PACKING COIL XL. DURING THE PROCEDURE, WHILE ADVANCING THE PACKING COIL XL INTO THE TARGET LOCATION, THE PACKING COIL XL UNINTENTIONALLY DETACHED. THE PACKING COIL XL WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923162 ↗
• MalfunctionNov 26, 2025Fracture; Unraveled Material; Physical Resistance/Sticking; Fracture; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A PACKING COIL XL, POD XLS, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO POD XL COILS AND ONE PACKING COIL XL IN THE TARGET LOCATION. WHILE ADVANCING ANOTHER PACKING COIL XL THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THE PACKING COIL XL HAD FRACTURED AND UNRAVELED. IT WAS REPORTED THE FRACTURED PORTION OF THE PACKING COIL XL THAT WAS STILL ATTACHED TO THE PUSHER ASSEMBLY WAS REMOVED, AND THE OTHER PARTIALLY FRACTURED PIECE OF THE PACKING COIL XL WAS INSIDE THE CATHETER. THE PHYSICIAN ATTACHED A SYRINGE TO THE CATHETER AND PULLED NEGATIVE PRESSURE THROUGH THE CATHETER, AND THE CATHETER WAS REMOVED CONTAINING THE PACKING COIL XL. THE ENTIRE PACKING COIL XL WAS REMOVED SUCCESSFULLY, AND NO PART OF THE PACKING COIL XL WAS LEFT IN THE PATIENT. 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 23660153 ↗