Rubicon™ 18 H74939239018130Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729832157), received between Dec 13, 2018 and Dec 4, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL BELOW THE KNEE. AN 18, 135CM RUBICON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE SUPPORT CATHETER 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 23719755 ↗
• MalfunctionJan 22, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A RUBICON 18, 135CM CATHETER AND A V-18 CONTROL WIRE WERE USED FOR LOWER LIMB STENT IMPLANTATION. DURING THE PROCEDURE, THE GUIDE WIRE AND THE RUBICON SUPPORT CATHETER BECAME STUCK AND COULD NOT BE SEPARATED. BOTH DEVICES WERE PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED AND WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21212292 ↗
• MalfunctionMay 22, 2024Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT THE SHAFT WAS DAMAGED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) VESSEL BELOW THE KNEE (BTK). A 135CM RUBICON 18 CATHETER-GUIDE SELECTED FOR SFA BTK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CASE AND LOADED ONTO THE NON-BOSTON SCIENTIFIC WIRE TO PASS THE LESION. HOWEVER, THE RUBICON CATHETER WAS REMOVED FROM THE PATIENT'S BODY AS IT BECAME STUCK WHILE FOLLOWING THE WIRE. IT WAS FOUND TO BE BUMPY IN THE MIDDLE PART OF THE CATHETER. THE PHYSICIAN COMPLAINED AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME PRODUCT. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FINE. HOWEVER, DEVICE ANALYSIS REVEALED DAMAGED AND PERFORATION TO THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378366 ↗
• MalfunctionFeb 20, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED, AND THE TREATMENT WAS DISCONTINUED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS, MODERATELY CALCIFIED BELOW THE KNEE ARTERY. A RUBICON GUIDE CATHETER WAS SELECTED FOR USE WITH A V-18 CONTROL WIRE FOR THE PROCEDURE. THE CALCIFIED STENOSIS IN THE LOWER LEG WAS RECANALIZED WITH THE V-18 CONTROL WIRE AND THE RUBICON GUIDE CATHETER WAS USED. WHEN ATTEMPTING TO REMOVE THE WIRE OUT OF THE RUBICON GUIDE CATHETER, IT WAS NOT POSSIBLE. THE RUBICON GUIDE CATHETER HAD TO BE REMOVED WITH THE WIRE AND IT WAS SUBSEQUENTLY DISCOVERED THAT THE TIP OF THE WIRE HAD BROKEN OFF. BOTH PARTS OF THE WIRE WERE STUCK IN THE RUBICON GUIDE CATHETER AND COULD THEREFORE BE RETRIEVED. AFTER RETRIEVING THE RUBICON GUIDE CATHETER WITH THE BROKEN WIRE, IT WAS NO LONGER POSSIBLE TO REACH THE TARGET VESSEL WITH A NEW WIRE, SO THE TREATMENT WAS DISCONTINUED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740416 ↗
• MalfunctionJun 26, 2023Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06 JUN 2023. IT WAS REPORTED, THAT THE GUIDEWIRE WAS STUCK. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS, AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 135CM RUBICON 18 CATHETER-GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE COULD NOT CROSS THE LESION. AND THE GUIDEWIRE GOT STUCK IN THE RUBICON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED, THE TIP WAS SEPARATED AND MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17204204 ↗
• MalfunctionFeb 3, 2022Fracture; Difficult to Advance; Material Deformation; Fracture; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE CATHETER FRACTURED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 135CM RUBICON 18 GUIDE CATHETER WAS SELECTED FOR USE. THE RUBICON GUIDE CATHETER WAS ADVANCED APPROXIMATELY 10 CM OVER A GUIDEWIRE, AND THEN IT BECAME STUCK. THE PROXIMAL SHAFT WAS NOTED TO BE KINKED. A SHAFT FRACTURE WAS OBSERVED APPROXIMATELY 40CM PROXIMAL FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446374 ↗
• MalfunctionDec 13, 2018Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A THE TIP OF THE CATHETER WAS BROKEN. A 135CM RUBICON18 GUIDE CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, WHEN REMOVING THE DEVICE, IT WAS NOTED THAT THE CATHETER COULD NOT BE WITHDRAWN WHEN IT HAD ALREADY CROSSED THE LESION ALONG WITH V18 GUIDEWIRE. IT WAS FURTHER NOTED THAT THE RUBICON CATHETER WAS GLUED TOGETHER WITH THE WIRE. THE PHYSICIAN COULD NOT SEPARATE THEM EVEN OUTSIDE THE PATIENT AND WHEN HE TRIED WITH ALL HIS FORCE TO DO THAT, IT WAS NOTED THAT THE TIP OF CATHETER WAS FRACTURED ON THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160241 ↗