Rubicon™ 18 H74939239018090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729832089), received between Dec 4, 2018 and Sep 12, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• InjurySep 12, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE CATHETER TIP DETACHED, THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS POPLITEAL AND SUPERFICIAL FEMORAL ARTERY. WHEN A PEDAL ACCESS WAS OBTAINED A 90CM RUBICON 18 CATHETER-GUIDE WAS INSERTED. DURING THE PROCEDURE, WHEN THE PATIENT MOVED HIS FEET SLIGHTLY, THE TIP OF THE CATHETER GOT KINKED AND SNAPPED IN HALF. FLUOROSCOPY WAS REVIEWED TO ENSURE THE DETACHED TIP DID NOT OBSTRUCT THE VESSEL. AFTER CONFIRMING THAT THE VESSEL WAS NOT OBSTRUCTED, THE PHYSICIAN PROCEEDED WITH THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17731543 ↗
• InjuryMar 31, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL PORTION OF THE CATHETER BROKE OFF AND REMAINED INSIDE THE PATIENT. THE APPROACH WAS VIA THE CONTRALATERAL SIDE ATTEMPTING TO CROSS RIGHT COMMON ILIAC STENOSIS. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND EXTREMELY CALCIFIED RIGHT COMMON ILIAC ARTERY. A 90CM RUBICON 18 GUIDE CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, A .014 WIRE WAS PASSED THEN AN ATTEMPT TO CROSS WITH A 018 RUBICON 90CM WAS MADE. THE RUBICON PASSED INTO THE DISTAL COMMON ILIAC LESION; HOWEVER, IT WOULD NOT GO ANY FURTHER. AFTER RETRIEVING THE RUBICON, IT WAS NOTED THAT THE DISTAL PORTION OF THE CATHETER BROKE OFF. THE DISTAL TIP OF THE CATHETER CONTAINING 2 MARKERS REMAINED BEHIND IN THE RIGHT COMMON ILIAC ARTERY. ULTRASOUND GUIDED ACCESS WAS OBTAINED ON RIGHT SIDE. A WIRE WAS PASSED FROM RIGHT SIDE INTO DISTAL AORTA. THE RIGHT COMMON AND EXTERNAL ILIAC ARTERY WAS PRE-DILATED. THEN A NON BOSTON SCIENTIFIC STENT WAS DEPLOYED CAPTURING THE 018 CATHETER TIP TO THE VESSEL WALL. POST DILATATION WAS DONE WITH A 6X100 MUSTANG BALLOON. POST ANGIO REVEALED EXCELLENT RESULTS WITH NO COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. PATIENT HAD BRISK FLOW

  Patient problems: Foreign Body In Patient

  MAUDE report 11600238 ↗
• InjuryOct 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER TIP PEELED OFF AND WAS RETRIEVED BY SNARE. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY ANTERIOR TIBIAL ARTERY (ATA). A 90CM RUBICON 18 WAS SELECTED FOR USE. DURING PROCEDURE, A .014 NON-BSC WIRE WAS EXCHANGED TO 300CM V-18 WIRE WITH THE RUBICON SUPPORT CATHETER. V-18 WIRE WAS POSITIONED DISTALLY, AND THE CATHETER WAS REMOVED. HOWEVER, THE CATHETER DID NOT MOVE UP AND THE TIP PEELED OFF AND BECAME STUCK IN THE ATA. SUBSEQUENTLY, A SNARE CATHETER WAS TRIED TO CHANNEL DOWN BUT THERE WERE A LOT OF RESTRICTIONS AS THE ANGLE OF THE LESION WAS ACUTE AND THE PROXIMAL PART OF THE TRIFURCATION WAS PERFORATED. A LARGER SHEATH SIZE AND A COVERED STENT WERE THEN USED TO STOP THE PERFORATION. THEN, THE RUBICON CATHETER TIP WAS RETRIEVED USING A SNARE CATHETER. BALLOON ANGIOPLASTY WAS COMPLETED, BUT THE FLOW WAS NOT IDEAL AS THE DIAGNOSTIC RUN. THE PROCEDURE WAS STOPPED, AND THE PUNCTURE POINT WAS CLOSED. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT A 9-15MM X 120CM NON BSC SNARE SYSTEM WAS USED TO RETRIEVE THE TIP OF THE RUBICON CATHETER.

  Patient problems: No Code Available

  MAUDE report 9175665 ↗
• InjuryDec 4, 2018Break; Break

  IT WAS REPORTED THAT THE RUBICON BROKE INTO MULTIPLE PIECES. A 90CM RUBICON 18 GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A V18 GUIDEWIRE TO THE CHRONIC TOTAL OCCLUSION SUB-INTIMAL. HOWEVER, WHEN THE RUBICON GUIDE CATHETER WAS ALSO PUSHED TO THE CTO SUB-INTIMAL, IT WAS NOTED THAT THE GUIDE CATHETER BROKE INTO MULTIPLE PIECES. CONSEQUENTLY, THE PHYSICIAN HAD TO REMOVE THE REMAINING BITS USING A SNARE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS POST-PROCEDURE WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8129696 ↗