Rubicon™ 14 H74939212014150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729832140), received between Oct 26, 2018 and Feb 10, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionFeb 10, 2026Fracture; Difficult to Advance

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A 14, 150CM (BOX/5) RUBICON WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE ATTEMPTED TO LOAD THE GUIDEWIRE, IT WOULD NOT PASS AND IT WAS FOUND THAT THE DEVICE WAS FRACTURED. 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 24309630 ↗
• MalfunctionDec 2, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A RUBICON 14 SUPPORT CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT VASCULAR STENOSIS. DURING THE PROCEDURE, THE WIRE BECAME STUCK IN THE CATHETER. 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 23693232 ↗
• MalfunctionFeb 16, 2022Difficult to Remove; Difficult to Remove

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25JAN2022. IT WAS REPORTED THAT A MICROWIRE WAS DIFFICULT TO REMOVE FROM THE CATHETER. THE 100% OCCLUDED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED TIBIALIS ANTERIOR DEXTRA. A 150CM RUBICON 14 WAS SELECTED FOR USE. DURING THE PROCEDURE, AT THE TIME OF ANGIOGRAPHY EVALUATION, THE MICROWIRE WAS DIFFICULT TO REMOVE FROM THE RUBICON 14 MICROCATHETER SO IT BROKE ON THE RUBICON 14 MICROCATHETER. THE DEVICE WAS REMOVED VIA JR 6FR GUIDE CATHETER AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS A SEPARATION LOCATED 166.5CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546430 ↗
• InjuryOct 26, 2018Break; Break

  IT WAS REPORTED VIA USER FACILITY REPORT # MW5079859 THAT THE WIRE TIP BROKE AND REMAINED INSIDE PATIENT'S BODY. A RUBICON 14 WAS SELECTED FOR USE. DURING PROCEDURE, WHILE TRYING TO CROSS THE CHRONICALLY OCCLUDED TIBIAL VESSEL, IT WAS NOTICED THAT 3MM OF THE TIP OF WIRE BROKE OFF IN THE HEAVILY CALCIFIED PORTION OF THE OCCLUSION. FURTHERMORE, THE DETACHED PORTION DID NOT AFFECT ARTERIAL FLOW OR CHANGE THE PATIENT'S CONDITION AND WAS LEFT IN PLACE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8010659 ↗