LP Coil System RBYLP0102-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948025950), received between Jan 12, 2026 and Apr 11, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILEOCOLIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING ADVANCEMENT OF A RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN NOTED RESISTANCE DESCRIBED AS A GRITTY FEEL, AND THE COIL DID NOT FULLY ADVANCE BEYOND THE DISTAL END OF THE MICROCATHETER. DURING RETRACTION, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH A SECOND RUBY COIL LP. THE MICROCATHETER CONTAINING THE SECOND DETACHED EMBOLIZATION COIL WAS ALSO REMOVED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NEW RUBY COIL LP AND THE SAME MICROCATHETER. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849271 ↗
• MalfunctionJan 12, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PSEUDO ANEURYSM OFF THE CELIAC ARTERY USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER ADVANCING THE RUBY COIL LP TEN CENTIMETERS INTO THE MICROCATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO ASPIRATE THE DETACHED EMBOLIZATION COIL OUT OF THE MICROCATHETER WITH A SYRINGE, BUT WAS UNSUCCESSFUL. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT A SECOND RUBY COIL LP WAS ADVANCED TO THE TARGET LOCATION, BUT WAS TOO LARGE FOR THE VESSEL. THE SECOND RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW MICROCATHETER AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24043719 ↗