LP Coil System RBYPCLP45Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00815948021945), received between Mar 31, 2020 and May 15, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (6 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.

• MalfunctionMay 15, 2024Fracture; Unraveled Material; Physical Resistance/Sticking; Fracture; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN COLLATERAL VEIN USING A PACKING COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER ADVANCING THE PACKING COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE PROXIMAL PORTION OF THE PACKING COIL LP WAS TOO CLOSE TO THE OSTIUM OF THE SUBCLAVIAN VEIN AND DECIDED TO REPOSITION THE PACKING COIL LP. AFTER RETRACTING APPROXIMATELY HALF OF THE PACKING COIL LP BACK INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND MADE MULTIPLE ATTEMPTS TO ADVANCE AND RETRACT THE COIL THROUGH THE MICROCATHETER BUT THE COIL WOULD NOT RESPOND. THE PHYSICIAN ATTEMPTED TO REMOVE THE PACKING COIL LP WHEN THE COIL HAD UNRAVELED AND UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. IT WAS ALSO REPORTED THE PACKING COIL LP HAD FRACTURED INTO SEPARATE SEGMENTS AFTER UNRAVELING. THEREFORE, THE PHYSICIAN CLAMPED DOWN ON THE MICROCATHETER TO REMOVE THE MICROCATHETER AND THE PACKING COIL LP TOGETHER AS UNIT; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. A SNARE DEVICE AND ANOTHER CATHETER WERE THEN USED TO REMOVE FRAGMENTS OF THE UNRAVELED PACKING COIL LP. A SNARE WAS USED FOR SEVERAL PASSES TO REMOVE PORTIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325731 ↗
• MalfunctionJun 7, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTOPULMONARY COLLATERAL ARTERIES USING PACKING COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A PACKING COIL LP INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT AND REPOSITION THE PACKING COIL LP. SUBSEQUENTLY, UPON RETRACTING THE PACKING COIL LP, THE PACKING COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL LP WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER. THEN, A SECOND PACKING COIL LP WAS ADVANCED INTO THE TARGET LOCATION AND THE PHYSICIAN ALSO DECIDED TO RETRACT AND REPOSITION THE SECOND PACKING COIL LP; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE MICROCATHETER CONTAINING THE SECOND DETACHED PACKING COIL LP WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING RUBY COIL LPS 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 17082295 ↗
• MalfunctionMay 13, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERCOSTAL VESSEL USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, IT WAS REPORTED WHILE ATTEMPTING TO EMBOLIZE THE VESSEL, THE PACKING COIL LP HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED PACKING COIL LP. THE PROCEDURE WAS COMPLETED USING NEW PACKING COIL LPS, RUBY COIL LPS, 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 14402752 ↗
• MalfunctionNov 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND PACKING COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS AND TWO PACKING COIL LPS WOULD NOT ADVANCE AT ALL FROM THEIR INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE TWO RUBY COIL LPS AND TWO PACKING COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COIL LPS AND PACKING COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12850662 ↗
• MalfunctionNov 12, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PACKING COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER PACKING COIL LP INTO THE TARGET LOCATION BUT THE PACKING COIL LP WAS TOO LONG FOR THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH THE PACKING COIL LP; HOWEVER, WHILE RETRACTING THE PACKING COIL LP BACK INTO THE INTRODUCER SHEATH, THE HOSPITAL TECHNOLOGIST KINKED THE PACKING COIL LP. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A 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 12807228 ↗
• MalfunctionJul 14, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR COLLATERAL ARTERY USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER ADVANCING A PACKING COIL LP OUT OF ITS INTRODUCER SHEATH AND APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST NOTICED THE PUSHER ASSEMBLY OF THE PACKING COIL LP TO BE KINKED. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING 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 12164774 ↗
• MalfunctionMay 5, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR USING PACKING COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE PACKING COIL LP FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PHYSICIAN WAS ABLE TO ADVANCE THE PACKING COIL LP THROUGH THE FRICTION LOCK; HOWEVER, THE PACKING COIL LP WOULD NOT ADVANCE THROUGH THE MICROCATHETER. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING 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 11780405 ↗
• MalfunctionMay 4, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LYMPHATIC VESSEL USING PACKING COILS LP. DURING THE PROCEDURE, TWO PACKING COILS LP WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE TWO PACKING COILS LP WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770764 ↗
• MalfunctionFeb 26, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LPS, RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WAS ADVANCED HALF-WAY THROUGH THE MICROCATHETER WHEN IT BECAME DIFFICULT TO ADVANCE AND SUBSEQUENTLY, THE PUSHER WIRE BECAME KINKED. THEREFORE, THE PACKING COIL LP WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH A RUBY COIL AND TWO MORE PACKING COIL LPS. THEREFORE, THESE COILS WERE ALSO REMOVED. 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 11388781 ↗
• MalfunctionOct 21, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATH. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING PENUMBRA COILS. 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 10713404 ↗
• MalfunctionSep 29, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS, RUBY COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED MULTIPLE PACKING COIL LPS AND RUBY COIL LPS INTO THE TARGET VESSEL THROUGH THE MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AFTER ADVANCING APPROXIMATELY HALF OF ANOTHER PACKING COIL LP INTO THE VESSEL; CONSEQUENTLY, THE REMAINING HALF OF THE PACKING COIL LP BECAME STUCK INSIDE THE MICROCATHETER AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PACKING COIL LPS, RUBY COIL LPS 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 10601205 ↗
• MalfunctionSep 18, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FOUR PACKING COIL LPS IN THE TARGET LOCATION. WHILE ADVANCING THE NEXT PACKING COIL LP THROUGH THE MICROCATHETER, IT BECAME STUCK MID-SHAFT. AFTER REMOVING THE PACKING COIL LP, THE PHYSICIAN NOTED THAT THE PUSHER ASSEMBLY HAD BECOME KINKED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PACKING COIL LPS 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 10556669 ↗
• MalfunctionMar 31, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTIC USING PACKING COIL LPS, RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE HANDLE. HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL, AND IT WAS OBSERVED THAT THE BLACK ALIGNMENT ZONE ON THE HANDLE HAD MINIMAL SEPARATION; SUBSEQUENTLY, THE PHYSICIAN USED THEIR FINGERS TO PIN AND PULL THE PUSHER ASSEMBLY OF THE PACKING COIL LP TO MANUALLY DETACH IT. IN THE MIDDLE OF THE PROCEDURE, A RUBY COIL LP (F94634) WAS FOUND KINKED UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL LP WAS FOUND PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN CONTINUED THE PROCEDURE, AND THE ISSUE WITH THE PACKING COIL LP OCCURRED WITH THREE ADDITIONAL PACKING COIL LPS AND TWO RUBY COILS LPS. ANOTHER HANDLE WAS OPENED AND USED WITH ATTEMPTS TO DETACH THE COILS, BUT IT IS UNKNOWN AT WHICH POINT THE SECOND HANDLE WAS USED; THEREFORE, THE COILS WERE ALSO MANUALLY DETACHED USING THE PIN AND PULL TECHNIQUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908828 ↗
• MalfunctionMar 31, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTIC USING PACKING COIL LPS, RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE HANDLE. HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL, AND IT WAS OBSERVED THAT THE BLACK ALIGNMENT ZONE ON THE HANDLE HAD MINIMAL SEPARATION; SUBSEQUENTLY, THE PHYSICIAN USED THEIR FINGERS TO PIN AND PULL THE PUSHER ASSEMBLY OF THE PACKING COIL LP TO MANUALLY DETACH IT. IN THE MIDDLE OF THE PROCEDURE, A RUBY COIL LP (F94634) WAS FOUND KINKED UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL LP WAS FOUND PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN CONTINUED THE PROCEDURE, AND THE ISSUE WITH THE PACKING COIL LP OCCURRED WITH THREE ADDITIONAL PACKING COIL LPS AND TWO RUBY COILS LPS. ANOTHER HANDLE WAS OPENED AND USED WITH ATTEMPTS TO DETACH THE COILS, BUT IT IS UNKNOWN AT WHICH POINT THE SECOND HANDLE WAS USED; THEREFORE, THE COILS WERE ALSO MANUALLY DETACHED USING THE PIN AND PULL TECHNIQUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908827 ↗