Rubicon™ 35 H74939240035090Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729832096), received between Jul 25, 2019 and Mar 30, 2026 — classified as 3 injuries, 4 malfunctions.

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

• MalfunctionMar 30, 2026Material Puncture/Hole; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT HOLE IN THE DEVICE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 35, 90CM RUBICON 35 WAS SELECTED FOR USE. DURING THE PROCEDURE. THE DEVICE BECAME KINKED, AND THE GUIDEWIRE EXITED THROUGH A HOLE AT THE KINKED SEGMENT. NO TROUBLESHOOTING STEPS WERE PERFORMED, AND THE DEVICE WAS REPLACED WITH A NEW CATHETER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730346 ↗
• InjurySep 21, 2023Break; Break

  IT WAS REPORTED THAT A CATHETER SEPARATION OCCURRED AND WAS REMOVED WITH A SNARE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 90CM RUBICON 35 GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, A CATHETER SEPARATION NEAR THE THIRD MARKER FROM THE TIP WAS NOTED. THE DEVICE FRAGMENT WAS REMOVED WITH SNARING DEVICE AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17794543 ↗
• MalfunctionJan 13, 2023Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS STUCK DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND TORTUOUS INTERNAL ILIAC ARTERY. A 90CM RUBICON 35 GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS TRIED TO BE PULLED BACK AND TAKEN OUT OF THE PATIENT'S BODY, IT WAS NOTED THAT IT GOT STUCK AND KINKED AT THE DISTAL END NEAR THE RO MARKER. THE PHYSICIAN WAS ABLE TO PULL THE WHOLE CATHETER OUT AND THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158490 ↗
• MalfunctionMay 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN. A 90CM RUBICON 35 GUIDE CATHETER WAS SELECTED FOR USE. DURING PREPARATION, WHILE PURGING THE DEVICE, IT WAS NOTED THAT THE CATHETER WAS BROKEN. NO ANOMALY WAS NOTED WITH THE POUCH PRIOR TO USE OF THE DEVICE AND THE POUCH WAS NOT PREVIOUSLY OPENED. THE DEVICE DID NOT ENTER THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826251 ↗
• MalfunctionMay 13, 2021Break; Entrapment of Device; Stretched; Break; Entrapment of Device; Stretched

  IT WAS REPORTED THAT THE CATHETER BROKE AND WAS UNABLE TO REMOVE FROM THE GUIDEWIRE. A 90CM RUBICON 35 WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE CATHETER BROKE. THE SURGEON WAS UNABLE TO REMOVE THE CATHETER FROM THE GUIDEWIRE AND BEGAN TO STRETCH WHEN TRIED TO SLIDE OFF THE GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11820686 ↗
• InjuryOct 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER BROKE INTO TWO PIECES AND WAS RETRIEVED BY SNARE. THE GREATER THAN 90% STENOSED TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND HEAVILY CALCIFIED EXTERNAL ILIAC ARTERY. A 90CM RUBICON 35 CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE CATHETER BROKE INTO TWO PIECES. THE PHYSICIAN NEVER LOST WIRE ACCESS FROM THE VESSEL OR CATHETER TIP. THE DEVICE WAS RETRIEVED USING A 6FR 45 CM SHEATH BY CINCHING THE SNARE LOOPS TO THE BROKEN RUBICON TIP AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10707112 ↗
• InjuryJul 25, 2019Break; Break

  IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. A 90CM RUBICON 35 WAS SELECTED FOR USE. UPON WITHDRAWAL, THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER FROM THE PATIENT'S BODY; HOWEVER, THE CATHETER SNAPPED. FEMORAL CUTDOWN DURING ENDARTERECTOMY WAS PERFORMED TO FACILITATE REMOVAL OF THE CATHETER. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8827489 ↗