Rubicon™ 35 H74939240035150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729832102), received between Dec 10, 2018 and May 17, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryMay 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A 150CM RUBICON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS FRACTURED AND WAS LEFT INSIDE THE PATIENT'S BODY. THE DEVICE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16950869 ↗
• MalfunctionJul 24, 2019Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CATHETER WAS DEFECTIVE. A 150CM RUBICON 35 WAS SELECTED FOR USE. THERE WERE "BARBS" NOTED ON THE OUTSIDE OF THE DEVICE WHEN THE DEVICE SHOULD BE SMOOTH. IT WAS REPORTED THAT THE "BARBS" COULD CAUSE VESSEL DAMAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8822379 ↗
• MalfunctionJan 30, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE DEVICE BROKE. THE TARGET LESION WAS LOCATED IN RIGHT FEMORAL ARTERY. A 150CM RUBICON 35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED OVER THE ILIAC BIFURCATION TO THE PATIENT'S LEFT SIDE. SUBSEQUENTLY, THE CATHETER WAS FOUND TO BE KINKED. THE DEVICE WAS REMOVED FROM THE PATIENT AND FOUND OUT THAT THE DEVICE WAS FRACTURED COMPLETELY THROUGH ON ONE SIDE. THERE WERE NO FRAGMENTS OF THE DEVICE THAT WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288823 ↗
• InjuryDec 10, 2018Break; Break

  IT WAS REPORTED THAT THE RUBICON SHAFT DETACHED.. A 150CM RUBICON 35 GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, A 300CM V-18 CONTROL WIRE WAS ADVANCED BUT FAILED TO CROSS THE LESION. THEN ANOTHER NON-BSC GUIDE WIRE CROSSED THE LESION. A 150CM RUBICON GUIDE CATHETER WAS ADVANCED IN A VERY HEAVILY CALCIFIED LESION IN THE COMMON FEMORAL ARTERY (CFA) WITH MULTIPLE WIRE EXCHANGES, IT WAS NOTED THAT 10CM OF THE DISTAL PART OF THE CATHETER BROKE AND BECAME STUCK IN THE VESSEL. THE BROKEN PIECE WAS THEN SNARED OUT OF THE PATIENT'S BODY. NO FURTHER PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147570 ↗