Rubicon 35Recalls & reported problems across all models

We found 3 models of Rubicon 35 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Dec 10, 2018 and Mar 30, 2026 — classified as 8 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Rubicon 35 problems

Rubicon 35 models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Rubicon™ 35 H74939240035130

  CATHETER, PERCUTANEOUS
  19 reports
• Rubicon™ 35 H74939240035090

  CATHETER, PERCUTANEOUS
  7 reports
• Rubicon™ 35 H74939240035150

  CATHETER, PERCUTANEOUS
  4 reports

Recent Rubicon 35 adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionApr 17, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE TIP OF THE WIRE PUNCTURED THROUGH THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 135CM RUBICON 35 CATHETER GUIDE WAS USED FOR LEG ANGIOGRAPHY PROCEDURE AND WAS PLACED OVER THE WIRE. AFTER THE WIRE WAS WITHDRAWN, THE ZIPWIRE HYDROPHILIC GUIDE WIRE WAS INSERTED INTO THE RUBICON CATHETER, BUT ADVANCING WAS DIFFICULT. IT WAS NOTED THAT THE WIRE PUNCTURED THROUGH THE RUBICON, CAUSING A HOLE. BOTH DEVICES WERE REMOVED, AND THE CENTER TIP OF THE WIRE WAS FOUND PROTRUDING FROM THE OUTER LAYER OF THE WIRE. A NEW GUIDEWIRE AND RUBICON WERE OPENED AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857274 ↗
• MalfunctionApr 9, 2025Material Perforation; Material Deformation; Material Perforation; Material Deformation

  IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERELY CALCIFIED PROXIMAL SUPERFICIAL FEMORAL ARTERY. A 135 CM RUBICON 35 CATHETER GUIDE WAS USED IN A LOWER EXTREMITY ANGIOGRAM. DURING THE PROCEDURE, THE RUBICON WAS USED TO NAVIGATE THROUGH A BYPASS. AN ANEURYSM WAS LOCATED NEAR THE TOP OF THE BYPASS. WHILE ATTEMPTING TO ADVANCE, BOTH THE NON-BOSTON SCIENTIFIC WIRE AND RUBICON WERE KINKED AT ABOUT 10 INCHES FROM THE TIP. IT WAS NOTED THAT THE WIRE HAD GONE THROUGH THE SIDE OF THE RUBICON, CONSEQUENTLY CAUSED A RIP. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21805435 ↗
• InjuryFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH THAT THE CATHETER TIP WAS BROKEN, AND ADDITIONAL INTERVENTION WAS PERFORMED. A RUBICON CATHETER GUIDE WAS SELECTED FOR USE IN AN ANGIOGRAM/ANGIOPLASTY OF LEFT LEG. DURING THE PROCEDURE, WHEN THE WIRE AND CROSSING CATHETER WAS REMOVED, A PIECE OF THE CATHETER TIP BROKE OFF ON THE PLAQUE IN THE ARTERY. WHEN TRYING REMOVE THE TIP, IT WAS UNSUCCESSFUL. A STENT WAS THEN PLACED IN ARTERY TO PREVENT TIP FROM MOVING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21308335 ↗
• MalfunctionDec 4, 2024Fracture; Material Perforation; Difficult to Advance; Fracture; Material Perforation; Difficult to Advance

  IT WAS REPORTED THAT SHAFT FRACTURE AND HOLE OCCURRED. A RUBICON 35 CATHETER-GUIDE WAS SELECTED FOR USE IN A POSSIBLE OCCLUDED SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE, AFTER BEING FLUSHED, IT WAS INSERTED OVER THE WIRE. CONTRAST WAS USED AND THE WIRE REINSERTED, HOWEVER, THE WIRE WOULD NOT COME OUT THE DISTAL END. A FEW ATTEMPTS WERE MADE AND UNDER XRAY, IT WAS NOTED THAT THE RUBICON WAS FRACTURED. THE RUBICON WAS SIMPLY REMOVED INTACT TOGETHER WITH THE WIRE. WHEN REMOVED, IT WAS NOTED THAT THE RUBICON HAD A HOLE/SLIT ON IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845893 ↗
• MalfunctionAug 15, 2024Material Perforation; Material Deformation; Material Perforation; Material Deformation

  IT WAS REPORTED THAT REPORTED THAT CATHETER PERFORATION OCCURRED. THE TARGET LESION WAS HIGHLY STENOSED AND WAS LOCATED IN THE MODERATELY TO SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON FEMORAL ARTERY (CFA), LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERIES (POP). A RUBICON 35, 135CM WAS SELECTED FOR TREATMENT. THE PHYSICIAN ATTEMPTED TO CROSS THE ILIAC BIFURCATION TO ADVANCE WIRE DOWN LEFT LOWER EXTREMITY PRIOR TO LONG SHEATH PLACEMENT BUT WAS UNSUCCESSFUL. THE RUBICON DEVICE WAS REMOVED INTACT, BUT IT WAS FOUND TO BE KINKED AND HAD A HOLE IN IT. ANOTHER OF THE SAME DEVICE WAS USED WITH A GLIDE WIRE TO CROSS THROUGH THE CHRONIC TOTAL OCCLUSION (CTO) AT THE CFA AND ADVANCE DOWN THE SFA. THE PHYSICIAN USED A 260CM AMPLATZ WIRE FOR ADDITIONAL SUPPORT TO UPSIZE THE SHEATH TO 7FR FOR AN ATHERECTOMY DEVICE. UPON REMOVING THE RUBICON, IT WAS STUCK ON THE WIRE, SO IT WAS TAKEN OUT OF THE SHEATH BUT STILL REMAINED STUCK AND APPEARED STRETCHED. THE PHYSICIAN DECIDED TO CUT THE PROXIMAL PORTION OF THE RUBICON DEVICE FROM THE WIRE TO AVOID LOSING WIRE ACCESS IN THE LESION. WHEN THE 7FR SHEATH WAS PLACED, THE AMPLATZ WAS REPLACED WITH DIFFERENT DEVICE BEFORE PLACING A V-18 G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995967 ↗
• MalfunctionNov 30, 2023Material Perforation; Material Perforation

  IT WAS REPORTED THAT A HOLE IN THE CATHETER WAS NOTED. A 135CM RUBICON 35 CATHETER WAS SELECTED FOR USE. DURING PREPARATION, WHILE LOADING THE CATHETER ON WIRE AND ADVANCING IT TOWARD THE SHEATH, A HOLE WAS NOTICED IN THE CATHETER. THE CATHETER WAS NEVER INSIDE THE SHEATH OR PATIENT, SO THE PHYSICIAN PULLED BACK OFF THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238165 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 25, 2023Material Perforation; Material Deformation; Material Perforation; Material Deformation

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A 260CM AND 035 X 135CM RUBICON ZIPWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN WAS TRYING TO CROSS A VERY CALCIFIED AORTIC BIFURCATION USING AN 035 X 135CM RUBICON AND A ZIPWIRE 260CM. THE RUBICON WAS KINKED AND UPON REMOVING THE CATHETER IT WAS SLIGHTLY BENT. ADDITIONALLY, WHEN THE TECH FLUSH THE RUBICON IT WAS NOTED THAT THERE WERE HOLES IN THE SIDE OF THE CATHETER AND WHEN THE ZIPWIRE WAS REMOVED THE COATING ON THE TIP OF THE WIRE HAD SHEARED OFF. THE PHYSICIAN CONTINUED WITH THE CASE AND WAS ABLE TO CROSS THE AORTIC BIFURCATION AND SUCCESSFULLY PERFORMED ATHERECTOMY USING A 2.5 ROTABLATOR ON THE LESIONS. FURTHERMORE, IT WAS NOTED AFTER A POST TREATMENT ANGIOGRAM THAT THERE WAS SOMETHING IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS PRESUMED TO BE THE COATING TIP OF THE ZIPWIRE SO THE PHYSICIAN DEPLOYED A 6MM X 40MM ELUVIA STENT TO ENSURE THE OBJECT DID NOT TRAVEL AND POSSIBLY EMBOLIZE THE DISTAL ARTERY. THE POST ANGIOGRAM PICTURES CONFIRMED BRISK FLOW THROUGHOUT THE RLE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812108 ↗
• 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 ↗
• MalfunctionOct 11, 2022Material Perforation; Material Deformation; Material Perforation; Material Deformation

  IT WAS REPORTED THAT A HOLE IN THE CATHETER OCCURRED. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 135CM RUBICON 35 CATHETER WAS SELECTED FOR USE. DURING AN ATTEMPT TO GET THROUGH THE OCCLUSION, IT WAS NOTED THAT THE DISTAL END OF THE CATHETER FOLDED ONTO ITSELF, AND THE WIRE POKED A HOLE THROUGH THE CATHETER. THE DEVICE WAS PULLED AND REMOVED INTACT FROM THE PATIENTS BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574359 ↗
• InjuryAug 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED IN HIGHLY TORTUOUS CORONARY ARTERY. A 135CM RUBICON 35 GUIDE CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE CATHETER TIP BROKE OFF INTO THE PATIENT'S AORTA. THE PHYSICIAN USED A SNARE TO RETRIEVE THE BROKEN CATHETER TIP AND WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS CANCELLED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Insufficient Information

  MAUDE report 12286748 ↗
• MalfunctionJun 8, 2021Entrapment of Device; Fracture; Entrapment of Device; Fracture

  IT WAS REPORTED THAT THE GUIDE CATHETER SNAPPED IN HALF. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 135CM RUBICON 35 CATHETER-GUIDE WAS SELECTED FOR USE. DURING WITHDRAWAL, THE RUBICON WAS REMOVED FROM THE PATIENT. OUTSIDE THE BODY, THE RUBICON WAS TRIED TO REMOVED FROM THE AMPLATZ GUIDEWIRE, HOWEVER THE RUBICON BECAME VERY TIGHT ON THE WIRE. A LOT OF FORCE WAS USED TO GET THE CATHETER OFF OF THE WIRE, HOWEVER, IT WAS NOTED THAT THE PROXIMAL END OF THE RUBICON SNAPPED IN HALF. BOTH PIECES OF THE DEVICE WERE ABLE TO BE REMOVED FROM THE WIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11956754 ↗
• MalfunctionMay 26, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE WAS NOT SEALED. A 135CM RUBICON 35 (BOX 5) WERE USED. THE BOTTOM OF THE PACKAGE WAS OPEN, AND THE STERILITY WAS COMPROMISED AS THE INNER POUCH WAS NOT SEALED. SUBSEQUENTLY, THEY PULLED ONE OUT OF THE BOX AND THE CATHETER FELL OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885300 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports