LP Coil System RBYPCLP03Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00815948021891), received between Mar 12, 2020 and Sep 18, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC BRANCHES USING PACKING COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. IT WAS REPORTED THAT THE BLACK ALIGNMENT ON THE PUSHER ASSEMBLY OF THE PACKING COIL LP HAD SEPARATED BUT THE COIL WAS STILL ATTACHED. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW PACKING COIL LP INTO THE VESSEL, BUT THE SAME ISSUE OCCURRED. WHILE ATTEMPTING TO REMOVE THE PACKING COIL LP, THE COIL DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN FLUSHED THE MICROCATHETER WITH SALINE AND PUSHED THE DETACHED PACKING COIL LP INTO THE TARGET VESSEL AND THE COIL WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP, SAME HANDLE, AND SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769901 ↗
• MalfunctionNov 17, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT PROSTATE BRANCH ANEURYSM USING PACKING COIL LP. DURING THE PROCEDURE, THE PACKING COIL LP WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, WHILE ATTEMPTING TO REMOVE THE PACKING COIL LP, THE PUSHER ASSEMBLY BECAME BENT. THEREFORE, THE PACKING COIL LP WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER PACKING COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832978 ↗
• MalfunctionOct 28, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GENICULATE ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE HOSPITAL TECHNOLOGIST WAS UNABLE TO ADVANCE A PACKING COIL LP OUT FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PACKING COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712097 ↗
• MalfunctionAug 19, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A COLLATERAL OF THE INTERNAL ILIAC ARTERY USING PACKING COIL LPS, RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA COIL, A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE. HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PACKING COIL LP WAS RETRACTED AND REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP. THEREFORE, THE PACKING COIL LP WAS ALSO REMOVED. THEN, THE PHYSICIAN ADVANCED THE NEXT PACKING COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PACKING COIL LP USING A SURGICAL CLAMP. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED A NON-PENUMBRA COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A SECOND HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PHY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344000 ↗
• MalfunctionAug 13, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING PACKING COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THREE PACKING COIL LPS USING THE HANDLE; HOWEVER, ALL THREE PACKING COIL LPS FAILED TO DETACH. THE PHYSICIAN ALSO TRIED USING ANOTHER HANDLE BUT WAS UNSUCCESSFUL. AFTERWARDS, THE PHYSICIAN WAS ABLE TO MANUALLY DETACH THE PACKING COIL LPS AFTER MULTIPLE ATTEMPTS. IT WAS REPORTED THAT THE FIRST HANDLE WORKED FINE WHILE PERFORMING A CLICK TEST; HOWEVER, WHILE TRYING TO DETACH THE COIL, THE HANDLE WOULD ONLY HALF CLICK AND SLOWLY RETURN TO ITS ORIGINAL POSITION WITHOUT DETACHING THE COIL. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL PACKING COIL LPS AND THE SECOND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321318 ↗
• MalfunctionJul 9, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS AND RUBY COIL LPS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO GET A PACKING COIL LP AND RUBY COIL LP (F102510 AND F99270) TO ANCHOR AND FORM IN THE SMALL AREA OF THE GDA. SUBSEQUENTLY, THE PACKING COIL LP AND RUBY COIL LP WERE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE A RUBY COIL LP (F99986); HOWEVER, THE COIL WAS UNABLE TO ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THE PHYSICIAN ATTEMPTED TO TROUBLESHOOT BY HOLDING THE BLACK STRIPE DISTALLY, BUT WAS UNSUCCESSFUL. 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 12147008 ↗
• MalfunctionJun 17, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PROCEDURE WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COIL LPS AND PACKING COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP AND PACKING COIL LP WERE STUCK AT THE FRICTION LOCKS AND UNABLE TO ADVANCE WITHIN THE INTRODUCER SHEATHS. THEREFORE, THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12018391 ↗
• MalfunctionJan 21, 2021Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRACHIAL ARTERY USING RUBY COILS LP, A PACKING COIL LP, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. AFTERWARDS, THE PHYSICIAN HAD DIFFICULTY ADVANCING TWO RUBY COILS LP AND ONE PACKING COIL LP WITHIN THEIR INTRODUCER SHEATHS; HOWEVER, THE PHYSICIAN WAS ABLE TO PLACE THE TWO RUBY COILS LP AND THE PACKING COIL LP IN THE TARGET LOCATION USING THE MICROCATHETER SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 11208329 ↗
• MalfunctionDec 22, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PACKING COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, ONE PACKING COIL LP WAS SUCCESSFULLY IMPLANTED IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT PACKING COIL LP THROUGH ITS INTRODUCER SHEATH, THE PUSHER WIRE BECAME KINKED. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PACKING COIL LP, THE SAME MICROCATHETER, AND THE SAME GUIDE 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 11060446 ↗
• MalfunctionNov 9, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS LP AND PACKING COILS LP. DURING THE PROCEDURE, THREE RUBY COILS LP AND ONE PACKING COIL LP WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS AND SUBSEQUENTLY, THE PUSHER ASSEMBLIES OF TWO COILS KINKED. THEREFORE, THE RUBY COILS LP AND PACKING COIL LP WERE REMOVED. IT IS UNKNOWN WHICH OF THE TWO COILS OUT OF THE FOUR WERE THE ONES THAT THE PUSHER ASSEMBLIES KINKED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS LP. 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 10812103 ↗
• MalfunctionOct 29, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LP. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PACKING COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE PACKING COIL LP TO READJUST IT. HOWEVER, WHILE RETRACTING THE COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND; CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE PACKING COIL LP BECAME KINKED. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PACKING COIL LP. 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 10758722 ↗
• MalfunctionAug 21, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING PACKING COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP THROUGH MICROCATHETER; HOWEVER, THE PACKING COIL LP WOULD NOT ADVANCE OUT THE TIP OF THE MICROCATHETER. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10440072 ↗
• MalfunctionMar 20, 2020Failure to Advance; Failure to Advance

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861840 ↗
• MalfunctionMar 12, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT COLIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PUSHER WIRE BECAME KINKED WHILE ADVANCING THE RUBY COIL LP INTO THE MICROCATHETER. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9826214 ↗