Rubicon™ 18 H74939239018150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729832164), received between Feb 12, 2020 and Jan 27, 2026 — classified as 1 injury, 4 malfunctions.

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

• MalfunctionJan 27, 2026Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERY OF LOWER EXTREMITY. A 150CM RUBICON CATHETER-GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER AND THE GUIDE WIRE WERE ENTANGLED WITH EACH OTHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191355 ↗
• MalfunctionMar 19, 2025Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation

  IT WAS REPORTED THAT SHAFT BURST OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 150 CM RUBICON 18 WAS USED FOR PROCEDURE. DURING THE PROCEDURE, THE WIRE WAS REMOVED FROM THE CATHETER TO TAKE A SHOT. A 3CC SYRINGE WAS CONNECTED TO THE CATHETER, AND UPON INJECTION, THE DISTAL TO THE HUB PART OF THE CATHETER STARTED TO BUBBLE AND EVENTUALLY POPPED OPEN AND BURST, SPRAYING CONTRAST. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644988 ↗
• InjuryApr 18, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED AND DETACHED PIECE WAS REMOVED THROUGH SNARING. THE MORE THAN 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL OF THE LEFT LOWER EXTREMITY. A 150CM RUBICON 18 CATHETER GUIDE WAS SELECTED FOR USE IN A LEFT LEG EXTREMITY ARTERIOGRAM. DURING THE PROCEDURE, THE RUBICON WAS ADVANCED PAST THE GUIDEWIRE AND RESISTANCE WAS MET. UPON PULLING BACK, THE CATHETER WAS KINKED. RUBICON CATHETER WAS TUGGED, AND IT WAS NOTED THAT THE CATHETER DETACHED AT THE SECOND RADIOPAQUE (RO) MARKER. THE REMAINDER OF THE CATHETER WAS REMOVED, AND THE DETACHED PIECE WAS SUCCESSFULLY RETRIEVED USING A NON-BOSTON SCIENTIFIC (BSC) SNARE KIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT FURTHER ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130526 ↗
• MalfunctionAug 24, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 150CM RUBICON 18 WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE BOTTOM OF THE PACKAGE WAS NOT SEALED AND THE DEVICE BECAME CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443366 ↗
• MalfunctionFeb 12, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21JAN2020. IT WAS REPORTED THAT A GUIDEWIRE AND CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT POSTERIOR TIBIAL ARTERY. A RUBICON WAS SELECTED FOR USE OVER A V18 GUIDEWIRE. DURING ATTEMPTS TO CROSS THE LESION, THE RUBICON AND V18 GUIDEWIRE BECAME ENTRAPPED WITH EACH OTHER. THE V18 GUIDEWIRE COULD NOT BE REMOVED FROM THE RUBICON AND THE DEVICES WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED SEPARATION AT 12CM FROM THE TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9700262 ↗