Rubicon™ 35 H74939240035130Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729832126), received between Mar 16, 2021 and Apr 17, 2025 — classified as 3 injuries, 16 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, 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 AFTER THE WIRE WAS WITHDRAWN, THE ZIPWIRE HYDROPHILIC GUIDE WIRE WAS INSERTED INTO THE RUBICON CATHETER, BUT ADVANCING WAS DIFFICULT.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 ↗
• 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 ↗
• 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 ↗
• 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 11885299 ↗
• 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 11885298 ↗
• 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 11885003 ↗
• 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 11884735 ↗
• MalfunctionMay 21, 2021Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE CATHETER WAS COMPROMISED. A 135CM RUBICON 35 GUIDE CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE PACKAGING OF THE RUBICON WAS NOT SEALED SO THE STERILE INTEGRITY WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863159 ↗
• MalfunctionMay 21, 2021Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE CATHETER WAS COMPROMISED. A 135CM RUBICON 35 GUIDE CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE PACKAGING OF THE RUBICON WAS NOT SEALED SO THE STERILE INTEGRITY WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863154 ↗
• MalfunctionMar 31, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT THE PROCEDURE WAS CANCELLED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). TWO 300CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRES AND A 135CM RUBICON 35 GUIDE CATHETER WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE FIRST GUIDEWIRE BECAME STUCK AT THE END OF THE RUBICON CATHETER AND SHEARED OFF IN THE DISTAL LEFT SFA. THE DETACHED FRAGMENT REMAINED IN THE PATIENT'S BODY. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE WIRE TIP AS THERE WAS NO FLOW IN THIS SEGMENT. SUBSEQUENTLY, THE SECOND GUIDEWIRE WAS USED BUT COULD NOT CROSS INTO THE TRUE LUMEN AND THE DISTAL TIP OF THE WIRE ALSO BECAME STUCK AT THE END OF THE RUBICON CATHETER. THE PHYSICIAN PULLED OUT BOTH CATHETER AND WIRE AT THE SAME TIME THROUGH THE SHEATH. THE WIRE WAS FRAYED BUT INTACT. THE PHYSICIAN REMOVED EVERYTHING FROM THE SFA AND ABORTED THE PROCEDURE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE RUBICON CATHETER ALSO FRAYED WHICH MAY HAVE CAUSED THE WIRES TO FRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597030 ↗
• InjuryMar 16, 2021Material Frayed; Detachment of Device or Device Component; Physical Resistance/Sticking

  ELDERLY FEMALE WITH 1-MONTH HISTORY OF GANGRENE OF THE LEFT 4TH AND 5TH TOES. ATTEMPTED CROSSING OF LEFT SUPERFICIAL FEMORAL ARTERY (SFA) CHRONIC TOTAL OCCLUSION; V-14 WIRE INSIDE A RUBICON CATHETER INSIDE THE PATIENT. THE WIRE WAS STUCK AND AS IT WAS PULLED BACK. TIP OF THE WIRE BROKE OFF BEING LEFT BEHIND IN THE PATIENT. A SECOND V-14 WIRE TO CONTINUE TO WORK ON THE PATIENT¿S LEG, THIS WIRE AS WELL GOT STUCK. THE WIRE HAD TO PULLED OUT WITH THE CATHETER TO AVOID ANOTHER TIP OF A WIRE BEING LEFT BEHIND. AFTER THE WIRE WAS ASSESSED IT WAS DETERMINED THAT THE TIP HAD NOT COMPLETELY DETACHED. THE RUBICON CATHETER ALSO HAD SOME FRAYING WHICH MAY HAVE CAUSED THE WIRES TO FRAY. "A V-14 WIRE WAS DIRECTED DOWN THE QUICK CROSS CATHETER. I EXCHANGED THE 035 QUICK CROSS CATHETER FOR AN 014 RUBICON CATHETER. MULTIPLE ATTEMPTS WERE MADE TO CROSS INTO THE TRUE LUMEN WHERE THE VESSEL REACH CONSTITUTED. AT 1 POINT THE WIRE TIP BECAME STUCK AT THE END OF THE RUBICON CATHETER AND SHEARED OFF IN THE DISTAL LEFT SFA CHRONIC TOTAL OCCLUSION. AS THERE WAS NO FLOW IN THIS SEGMENT, I DID NOT BOTHER ATTEMPTING TO RETRIEVE IT. I ATTEMPTED TO USE ANOTHER 014 WIRE BUT COULD NOT CROSS INTO THE TRUE LUMEN. ONC

  Patient problems: Insufficient Information

  MAUDE report 11494290 ↗