LP Coil System RBYLP0860Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00815948021884), received between Sep 18, 2020 and Dec 8, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS, PACKING COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP AND PACKING COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH THE COILS USING THE HANDLE; HOWEVER, THE RUBY COIL LP AND PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL LP AND PACKING COIL LP AND DETACHED ANOTHER RUBY COIL LP AND PACKING COIL LP IN THE TARGET VESSEL WITHOUT ISSUE. WHILE ATTEMPTING TO DETACH ANOTHER RUBY COIL LP IN A LARGER VESSEL, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL LP AND SUCCESSFULLY DETACHED ANOTHER RUBY COIL LP IN THE TARGET VESSEL WITHOUT ISSUE. 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 12961092 ↗
• MalfunctionDec 5, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING A PACKING COIL LP, RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE PACKING COIL LP INTO THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST HAND WAS HOLDING THE COIL AT THE STARTING POSITION OF THE INTRODUCER SHEATH AND, CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE PACKING COIL LP BECAME BENT. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE HOSPITAL TECHNOLOGIST THEN ATTEMPTED TO ADVANCE TWO RUBY COIL LPS INTO THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL LP COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931059 ↗
• MalfunctionNov 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL LP OUT FROM THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP 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 12775493 ↗
• MalfunctionSep 28, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE RUBY COIL LP USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN MANUALLY DETACHED THE RUBY COIL LP SUCCESSFULLY BY BREAKING THE BACK END OF THE PUSHER ASSEMBLY. IT WAS REPORTED THAT THE SAME HANDLE WAS USED TO DETACH OTHER COILS. 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 12540957 ↗
• MalfunctionSep 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12449917 ↗
• MalfunctionAug 6, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING RUBY COIL LPS AND PACKING COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE PAST ITS FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER RUBY COIL LP IN THE TARGET VESSEL. NEXT, WHILE ATTEMPTING TO ADVANCE A PACKING COIL LP, IT WOULD NOT ADVANCE PAST ITS FRICTION LOCK WITHIN ITS INTRODUCER SHEATH AS WELL. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER PACKING COIL LP IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL LP COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12290405 ↗
• MalfunctionAug 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPLENIC ARTERY USING PACKING COIL LPS AND RUBY COIL LPS. DURING THE PROCEDURE, A PACKING COIL LP AND RUBY COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION OF THEIR INTRODUCER SHEATHS. THEREFORE, THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PENUMBRA AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257718 ↗
• MalfunctionJul 15, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA SMART COILS (SMART COIL), A RUBY COIL LP, A PACKING COIL LP, A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A BENCHMARK MAX IN THE RIGHT JUGULAR VEIN. THE PHYSICIAN THEN PLACED TWO SMART COILS INTO THE CAROTID CAVERNOUS SINUS USING THE MICROCATHETER. AFTERWARDS, A RUBY COIL LP AND A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS; THEREFORE, THE RUBY COIL LP AND THE SMART COIL WERE REMOVED. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING APPROXIMATELY TEN CENTIMETERS OF A PACKING COIL LP THROUGH THE DISTAL END OF THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO RETRACT THE PACKING COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE AND HEARD A POPPING SOUND. THE PHYSICIAN THEN REMOVED THE PUSHER ASSEMBLY OF THE PACKING COIL LP AND NOTICED THE COIL BROKE AND UNRAVELED. AFTERWARDS, THE MICROCATHETER WAS REMOVED AND IT WAS NOTICED THAT THE REMAINING COIL WAS HANGING FROM THE HUB OF THE BENCHMARK MAX. SUBSEQUENTLY, WHILE THE PHYSICIAN ATTEMPTED TO PULL ON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171168 ↗
• MalfunctionJun 16, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. 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 12006349 ↗
• MalfunctionJun 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS AND RUBY COIL LPS. DURING THE PROCEDURE, ONE PACKING COIL LP AND TWO RUBY COIL LPS HAD FRICTION LOCKS THAT WOULD NOT DISENGAGE, AND THE COILS WOULD NOT ADVANCE IN THE INTRODUCER SHEATHS. THEREFORE, THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986184 ↗
• MalfunctionJun 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS AND RUBY COIL LPS. DURING THE PROCEDURE, ONE PACKING COIL LP AND TWO RUBY COIL LPS HAD FRICTION LOCKS THAT WOULD NOT DISENGAGE, AND THE COILS WOULD NOT ADVANCE IN THE INTRODUCER SHEATHS. THEREFORE, THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986153 ↗
• MalfunctionApr 1, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTA ANEURYSM (AAA) USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA 5FR ANGIO CATHETER, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE HANDLE MADE AN AUDIBLE CLICK, BUT THE RUBY COIL LP FAILED TO DETACH. THE HOSPITAL TECHNOLOGIST MADE THREE MORE ATTEMPTS TO DETACH THE RUBY COIL LP USING THE HANDLE, BUT THE RUBY COIL LP STILL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A NEW RUBY COIL LP AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE, BUT THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND THE SAME RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603067 ↗
• MalfunctionSep 18, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RENAL ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ADVANCE A RUBY COIL OUT OF THE MICROCATHETER HUB. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SAME MICROCATHETER. 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 10556975 ↗