LP Coil System RBYLP0510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948021839), received between Jan 21, 2021 and Nov 30, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE PAST THEIR INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE TWO RUBY COIL LPS WERE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY IMPLANT ONE RUBY COIL LP IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12901525 ↗
• MalfunctionOct 15, 2021Failure to Advance; Failure to Advance

  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, WHILE ATTEMPTING TO ADVANCE A RUBY COIL LP, THE RUBY COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH A SECOND RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. IT WAS REPORTED THAT THE HOSPITAL STAFF ATTEMPTED TO TROUBLESHOOT THE ISSUES BY REPOSITIONING THE PLACEMENT OF HANDS ON THE RUBY COIL LPS, FLUSHING THE RUBY COIL LPS, AND PULLING THE COILS BACK; HOWEVER, IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING ONE RUBY COIL LP AND TWO PACKING COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642779 ↗
• MalfunctionAug 31, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) TO TREAT A TYPE II ENDOLEAK USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE RUBY COIL LP INTO THE ANEURYSM, THE RUBY COIL LP KICKED THE MICROCATHETER OUT OF THE TARGET VESSEL DUE TO THE RUBY COIL LP BEING BIG FOR THE SIZE OF THE ANEURYSM. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. WHILE ATTEMPTING TO RETRACT AND RECAPTURE THE RUBY COIL LP, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL LP AT MULTIPLE LOCATIONS. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE RUBY COIL LP DUE TO THE TORTUOUS ANATOMY OF THE PATIENT. NEXT, THE PHYSICIAN ADVANCED A SMALLER RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN MADE ADDITIONAL ATTEMPTS TO DETACH THE RUBY COIL LP USING A NEW HANDLE AND BY MANUALLY DETACHING IT BUT WERE UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12402252 ↗
• 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 11208370 ↗