LP Coil System RBYLP0630Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815948021860), received between Dec 2, 2020 and May 13, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2022Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) AND THE GASTROEPIPLOIC ARTERY (GEA) USING RUBY COIL LPS, A PACKING COIL LP, A LP SYSTEM DETACHMENT HANDLE (LP HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RUBY COIL LPS INTO THE TARGET VESSEL USING THE LP HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL LP INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL LP BACK INTO THE MICROCATHETER TO REPOSITION IT. WHILE RETRACTING, THE RUBY COIL LP UNINTENTIONALLY DETACHED AND MIGRATED DISTALLY INTO THE LEFT GASTROEPIPLOIC ARTERY (LGEA). THE RUBY COIL LP WAS LEFT IN THE AREA IT HAD MIGRATED TO. THE PHYSICIAN THEN IMPLANTED THREE ADDITIONAL RUBY COIL LPS INTO THE TARGET VESSEL USING THE LP HANDLE. NEXT, THE PHYSICIAN ADVANCED A PACKING COIL LP INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE LP HANDLE. HOWEVER, THE PACKING COIL LP FAILED TO DETACH. IT WAS REPORTED THAT THE PHYSICIAN PULLED THE TRIGGER OF THE LP HANDLE BACK AND SAW THE TWO MARKERS INDICATING THAT THE PACKING COIL LP HAD DETACHED. HOWEVER, WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402748 ↗
• MalfunctionJul 21, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TEMPORAL ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE OUT FROM THE FRICTION LOCK. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204300 ↗
• MalfunctionApr 30, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET VESSEL AND THE MICROCATHETER WAS SUBSEQUENTLY FLUSHED. WHILE ATTEMPTING TO ADVANCE THE NEXT RUBY COIL LP, RESISTANCE WAS ENCOUNTERED, AND THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN THE INTRODUCER SHEATH. THE PHYSICIAN CONTINUED MAKING ATTEMPTS TO ADVANCE THE RUBY COIL LP AND IT WAS EVENTUALLY ADVANCED INTO THE MICROCATHETER; HOWEVER, THE COIL WOULD NOT SMOOTHLY ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758056 ↗
• MalfunctionDec 29, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11085572 ↗
• MalfunctionDec 2, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ENDOLEAK USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER AND CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER AND USED A HANDLE TO DETACH IT, HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP AND HANDLE WERE REMOVED. THE PHYSICIAN THEN ENCOUNTERED THE SAME ISSUE WITH THE NEXT RUBY COIL LP AND HANDLE, THEREFORE, THE RUBY COIL LP AND HANDLE WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER, AND CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10933700 ↗