ENROUTE 0.014" Guidewire 901047-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00816349014857), received between Jul 25, 2025 and Aug 25, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Difficult to Advance

  eCN Event Description: After the karate sheet was placed, we noticed that the 014 wire was not behaving as normal. It was buckling. We took an angiogram and did not notice a dissection and decided to open a new 014 wire. The second wire was also behaving strangely took another angiogram still did not notice a dissection. Placed a 40 CM kumpe catheter onto the wire and it would not advance past the distal common carotid. Shot another angiogram and noticed the dissection.Patient present at time of event?: YesPatient Complications: DissectionIn the physician's opinion, did the device or procedure cause or contribute to the patient complication?: YesPlease describe the way in which the device or procedure caused or contributed to the patient complication?: The left common carotid artery dissected while placing the 8fr carotid sheathMedical or Surgical Interventions: Conversion from TCAR to CEAPatient admitted to hospital beyond the standard of care: NoPatient Outcome: Expected to fully recoverThis is the third lot number impacted by this issue as confirmed by the customer (b)(6) 2026.A ship History was completed, and these are the 3 lot numbers that are associated with these complaints

  Patient problems: Vascular Dissection

  MAUDE report 50426900 ↗
• MalfunctionJul 29, 2026Difficult to Advance

  Patient problems: Vascular Dissection

  MAUDE report 50067449 ↗
• MalfunctionFeb 19, 2026Difficult to Advance

  DR. (B)(6) OBTAINED ACCESS TO THE CCA UTILIZING THE SILK ROAD MICROPUNCTURE KIT. AN ANGIOGRAM WAS PERFORMED WHICH SHOWED NO ABNORMALITIES. THE 0.035' GUIDEWIRE FROM THE ENROUTE NEUROPROTECTION KIT WAS THEN INSERTED INTO THE CCA USING THE STOP SHORT METHOD. THE MICROSHEATH WAS REMOVED AND THE 8F ARTERIAL SHEATH FROM THE ENROUTE NPS KIT WAS INSERTED. THE FLOW CONTROLLER TUBING WAS CONNECTED FROM THE ARTERIAL SHEATH, PRIMED, AND CONNECTED TO THE VENOUS SHEATH. ACT AND VITALS WERE IN THE APPROPRIATE RANGES FOR THE CAROTID WAS CLAMPED. ANOTHER ANGIOGRAM WAS TAKEN WHICH DID NOT SHOW ANY VISIBLE ABNORMALITIES. DR. (B)(6) ATTEMPTED TO ADVANCE THE 0.014' ENROUTE GUIDEWIRE BUT THE WIRE APPEARED TO PROLAPSE MID CCA AND WAS BEHAVING ABNORMALLY. HE GENTLY PULLED THE SHEATH TIP BACK AND ROTATED THE C-ARM TO TAKE ANOTHER ANGIOGRAM. THERE WAS CONCERN FOR A DISSECTION AT THIS POINT, SO DR. (B)(6) REMOVED THE 8F SHEATH FROM THE CCA, CLOSED THE PUNCTURE SITE WITH THE 5.0 PROLENE PRE-STITCH, AND REACCESSED MORE PROXIMAL THIS TIME. USING THE SAME STEPS AS BEFORE, HE SAFELY INSERTED THE 8F ARTERIAL SHEATH AGAIN AND RECONNECTED THE WHOLE CIRCUIT WITH THE FLOW CONTROLLER TUBING. AN ADDITIONAL ANGIOGRAM WA

  Patient problems: Vascular Dissection

  MAUDE report 24387825 ↗
• MalfunctionJan 20, 2026Difficult to Advance

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: PATIENT WAS HAVING A SYMPTOMATIC RIGHT TCAR WITH DR. PATIENT WAS FILTERED THROUGH THE ALLINA SYSTEM AND TRANSFEMORAL STENTING WAS ATTEMPTED FIRST BUT BECAUSE OF THE TORTUOSITY OF THE ICA A FILTER COULDN'T BE PASSED SO PATIENT WAS REFERRED TO VASCULAR SURGERY. STROKE WAS OVER 3 MONTHS AGO, AND THE PATIENT SYMPTOMS HAD RESOLVED. THERE IS NO P2Y12 TESTING BUT PATIENT WAS ON ASPIRIN, PLAVIX AND STATIN. ALL PRODUCTS WERE PREPPED AND SET UP CORRECTLY. THE PHYSICIAN TUNNELED OUR SHEATH AND WHEN HE ADVANCED THE .035 WIRE IT MOVED FREELY, AND A GOOD "J" WAS FORMED. 8FR SHEATH WAS ADVANCED WITHOUT ANY DIFFICULTY. AT THIS POINT HE CONNECTED THE SHEATHS TO OUR NEUROPROTECTION SYSTEM, AND WE TOOK OUR WORKING VIEWS. NO DISSECTION WAS NOTED BUT WE DID DISCUSS THE SEVERITY OF THE TORTUOSITY IN THE DISTAL ICA. PATIENT WAS THEN PUT ON FLOW REVERSAL AND WE CONFIRMED WITH A SALINE SYRINGE. THE .014 WAS ADVANCED WITH SOME DIFFICULTY BUT DUE THE PATIENT ANATOMY AND SEVERITY OF TORTUOSITY IN THE DISTAL ICA THE PHYSICIAN SAID IT WAS PROBABLY DUE TO THAT SO WE PROCEEDED WITH THE PROCEDURE. ON POST IMAGING A DISSECTION WAS NOTED PROXIMAL TO STENT AND THERE WAS NOT A

  Patient problems: Vascular Dissection

  MAUDE report 24115955 ↗
• MalfunctionJan 19, 2026Difficult to Advance

  ECN EVENT DESCRIPTION: NEURO PROTECTION KIT WAS SUCCESSFULLY PLACED AND FULL REVERSE FLOW WAS ESTABLISHED. UPON ADVANCING THE WIRE AND BALLOON, THE BALLOON STARTED BUMPING INTO THE CALCIFIED LESION AND CCA WALL, AND BUCKLED, WHICH CAUSED THE ARTERIAL SHEATH TO BACK OUT APPROXIMATELY 1 TO 1.5CMS. BALLOON AND .014' WIRE WERE REMOVED, AND .035 J WIRE AND DILATOR WERE INSERTED, AND PHYSICIAN ATTEMPTED TO ADVANCE THE ARTERIAL SHEATH BACK TO IT'S ORIGINAL POSITION. THE ARTERIAL SHEATH APPEARED TO ADVANCE, AND AN ARTERIOGRAM WAS CONDUCTED TO VIEW EVERYTHING WAS SATISFACTORY. IT WAS AT THAT POINT THAT EXTRUSION WAS NOTED. THE ARTERIAL SHEATH WAS REMOVED AND ACCESS SITE CLOSED, AND PHYSICIAN ATTEMPTED TO REPAIR AND VISUAL DEFECTS. HE ATTEMPTED ACCESS SLIGHTLY PROXIMAL TO THE ORIGINAL ACCESS SITE, AND EXTRUSION WAS STILL NOTED. HE THEN MADE THE DECISION TO CONVERT TO CEA AND REPAIR AND DAMAGE/DEFECTS. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? REMOVED ARTERIAL SHEATH, AND ATTEMPTED TO RE-STICK PROXIMAL TO ORIGINAL ACCESS SITE. WHAT IS THE NEXT COURSE OF ACTION? NO NEXT COURSE. PHYSICIAN CONVERTED TO CEA, AND DID THE REPAIR OPEN. PATIENT PRE

  Patient problems: Vascular Dissection

  MAUDE report 24108479 ↗
• MalfunctionJan 15, 2026Difficult to Advance

  ECN EVENT DESCRIPTION: PATIENT PREPPED AND DRAPED IN STERILE FASHION. THE CAROTID ARTERY WAS EXPOSED AND UPON ACCESS OF THE CCA WITH THE ENROUTE MPK THE ACCESS WIRE WAS DIFFICULT TO ADVANCE. THE MPK SHEATH WAS RETRACTED SLIGHTLY AND THEN THE WIRE WAS ADVANCED. THE ECA WAS SELECTED, THE STIFF J-WIRE WAS INSERTED AND THE NPS ARTERIAL SHEATH WAS INSERTED. THE PROCEDURE CONTINUED NORMALLY, UNTIL THE CLAMP WAS APPLIED AND THE .014 WIRE WAS INTRODUCED. IT ADVANCED SEEMINGLY NORMALLY UNTIL MIDWAY UP THE CCA. AFTER SOME MANIPULATION THE WIRE WAS ADVANCED FURTHER UP PAST THE BIFURCATION. IT WAS DECIDED TO TAKE AN ANGIO AS THE WIRE PLACEMENT COULD NOT BE CONFIRMED. THE ANGIO SHOWED THE WIRE DIRECTED MORE TOWARDS THE ECA. THE WIRE WAS RETRACTED AND A NEW .014 WIRE WAS INSERTED. AFTER SOME MANIPULATION IT WAS ADVANCED INTO THE ICA AND TO THE PETROUS RIDGE. ANGIOPLASTY AND STENTING WAS PERFORMED AND AFTER A 2 MIN WASH TIME ANGIOGRAPHY WAS PERFORMED. A SIGNIFICANT DISSECTION WAS OBSERVED IN THE CCA FROM THE SHEATH TIP UP TO THE CAROTID BIFURCATION. IT WAS DECIDED TO PLACE A 2ND STENT TO TACK DOWN THE DISSECTION. AFTER PLACEMENT OF THE 2ND STENT ANGIOGRAPHY WAS PERFORMED DEMONSTRATING NO VISIBLE

  Patient problems: Vascular Dissection

  MAUDE report 24080495 ↗
• MalfunctionNov 21, 2025Difficult to Advance; Difficult to Advance

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: DR. ISOLATED THE CAROTID ARTERY AND USED OUR MICROPUNCTURE KIT TO OBTAIN ACCESS. HE TOOK AN ANGIOGRAM WHICH DID NOT DEPICT ANY ABNORMALITIES, THEN USED OUR 0.035' J WIRE TO PLACE THE 8F ARTERIAL SHEATH INTO THE ARTERY USING THE STOP SHORT METHOD. FLOW REVERSAL WAS CONNECTED AND THE CAROTID ARTERY WAS CLAMPED. DR. TOOK ANOTHER ANGIOGRAM TO OBTAIN OUR WORKING IMAGE FOR PRE-DILATION AND STENT PLACEMENT THIS SHOWED NO ABNORMALITIES. HE THEN ADVANCED THE 0.014' GUIDEWIRE INTO THE ICA AND CONFIRMED LOCATION BY GUIDING IT INTO THE PETROUS RIDGE PORTION OF THE SKULL BASE. DR. USED A VIATRAC BALLOON FOR PRE-DILATION, PLACED AN ENROUTE STENT, AND POST-DILATED WITH ANOTHER VIATRAC BALLOON. AFTER THE 2MIN WASHOUT PERIOD ANOTHER ANGIOGRAM WAS OBTAINED. THERE WAS A POTENTIAL DISSECTION NOTED JUST BEYOND THE DISTAL PORTION OF THE STENT IN THE ICA. DR. TOOK ANOTHER ANGIOGRAM IN A DIFFERENT ANGLE TO CONFIRM AND DECIDED TO PLACE A SECOND STENT DISTAL TO THE FIRST STENT IN ORDER TO COVER THE POTENTIAL DISSECTION. A SECOND STENT WAS PLACED; TWO MINUTE WASHOUT PERIOD WAS OBSERVED AND ANOTHER ANGIOGRAM DONE. DR. WAS SATISFIED WITH THE SECOND STENT PLACEMENT AND

  Patient problems: Vascular Dissection

  MAUDE report 23615901 ↗
• MalfunctionNov 3, 2025Difficult to Advance; Difficult to Advance

  ECN EVENT DESCRIPTION: AFTER INSERTION OF ARTERIAL SHEATH AND PERFORMING INITIAL ANGIOGRAM PHYSICIAN TRIED TO ADVANCE GUIDEWIRE INTO THE VESSEL AND WAS UNABLE TO ADVANCE WIRE THROUGH LESION. ADVISED DOCTOR TO PERFORM ANOTHER ANGIOGRAM IN ANOTHER ORTHOGONAL VIEW TO CHECK FOR COAXIAL SHEATH POSITION. PHYSICIAN DID NOT WANT TO MAKE ANOTHER ANGIOGRAM AT THIS TIME AND REQUESTED ANOTHER WIRE. MULTIPLE ATTEMPTS MADE TO GUIDE WIRE THROUGH LESION WITHOUT SUCCESS. ADVISED PHYSICIAN TO TAKE ANOTHER ANGIOGRAM. UPON ANGIOGRAM, DISSECTION NOTED IN COMMON CAROTID ARTERY DISTAL TO SHEATH INSERTION SITE. ADVISED PHYSICIAN TO REPOSITION SHEATH AND TRY TO GUIDE WIRE OUT OF DISSECTION. UNABLE TO GUIDE WIRE OUT OF DISSECTION. ADVISED PHYSICIAN TO CLOSE ARTERIOTOMY SITE AND TRY TO ACCESS AGAIN. PHYSICIAN OPTED TO ABORT TCAR PROCEDURE AND DO CAROTID ENDARTERECTOMY. PATIENT PRESENT AT TIME OF EVENT? YES, PATIENT COMPLICATIONS: DISSECTION IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION? NO MEDICAL OR SURGICAL INTERVENTIONS: CAROTID ENDARTERECTOMY PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: NO PATIENT OUTCOME: UNKNOWN EVENT DATE: 2025-10-

  Patient problems: Vascular Dissection

  MAUDE report 23449135 ↗
• MalfunctionOct 3, 2025Fracture; Fracture

  ECN EVENT DESCRIPTION: PATIENT PLACED ON TABLE AWAKE AND ALERT MOVING ALL EXTREMITIES. TCAR PROCEEDED AS PLANNED AND DISCUSSED WITH MD. TCAR TIMEOUT PERFORMED AND PATIENT PLACED ON REVERSE FLOW. MD INTRODUCED WIRE AND 5X30 STERLING BALLOON INTO SHEATH AND ADVANCE TO PROXIMAL CAROTID. MD NOTED DIFFICULTY AND FRICTION WHEN ADVANCING THE WIRE TO ENGAGE INTERNAL CAROTID (IC). WIRE SELECTED EXTERNAL CAROTID (EC) AND THEN PULLED BACK WITH MD AGAIN NOTING DIFFICULTY. IC WAS THEN SELECTED AND WIRE ADVANCED. BALLOON INFLATION DONE. BALLOON REMOVED AND STENT INSERTED, BUT MD DID NOT NOTE ANY DIFFICULTY DURING DEVICE EXCHANGED. STENT PLACED IN IC AS PLANNED. STENT DELIVERY SYSTEM AND WIRE REMOVED TOGETHER AND 2 MINUTE WASHOUT COMPLETED. THE DISTAL WIRE TIP (AROUND 5-7CM) WAS OBSERVED TO HAVE BEEN MANGLED WITH THE DISTAL COILS DETACHED FROM SHAFT AND CORE. FINAL ANGIO DONE AND WE NOTICED SMALL RADIOOPAQUE (RO) MARKER ON X-RAY DISTAL TO THE STENT. MD AND I BELIEVED IT WAS IN THE IC DUE TO IT BEING OVER THE DISTAL ICA ON X-RAY. MD DID NOT CHANGE X-RAY ANGULATION AFTER IT WAS SUGGESTED. A NEW ENROUTE 014 WIRE WAS RETRIEVED. A 10MM SNARE WAS USED IN THE IC TO ATTEMPT TO RETRIEVE THE TIP BUT WAS UN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23208369 ↗
• MalfunctionSep 19, 2025Difficult to Advance; Difficult to Advance

  ECN EVENT DESCRIPTION: ACCESS AND LESION EVALUATION WERE DONE IN STANDARD TCAR PROTOCOL, TCAR TIME OUT WAS DONE AND LANDMARKS WERE IDENTIFIED. THE WIRE WAS ADVANCED THROUGH THE LESION A SLIGHT BUCKLING WAS NOTED AND WIRE WAS PULLED BACK AND READVANCED SMOOTHLY THROUGH THE ICA TO THE PETROUS RIDGE. PROCEDURE WAS DONE 2 STENTS WERE PLACED. 3 MINUTE WASHOUT TIME WAS FOLLOWED. SLOW FLOW AND PETROUS RIDGE WAS NOT IDENTIFIED IN THE COMPLETION ANGIO. IVUS WAS UTILIZED TO IDENTIFY IF A DISSECTION WAS PRESENT IN THE DISTAL ICA IT WAS NOTED TO EXTEND INTO THE PROXIMAL PETROUS RIDGE. AN ADDITIONAL 5X 40 CPRDIS PRECISE STENT AND 7X30 ENROUTE STENT WERE USED TO COVER THE DISSECTION. 2 MINUTE WASHOUT WAS DONE COMPLETION ANGIO SHOW BRISK FLOW TO THE BRAIN. PATIENT WOKE WITH FULL MOVEMENT, AND UNIFORM FACIAL RESPONSE. IT WAS NOTED THAT THE PATIENT HAD SEVER PAIN IN HER 'MOLARS' AND SUBSEQUENT CT POST PROCEDURE SHOWED NO BLEEDING. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? IT WAS NOTED A FLOW LIMITING DISSECTION DISTAL TO OUR LESION INTO THE PETROUS RIDGE. WHAT IS THE NEXT COURSE OF ACTION? TWO ADDITIONAL STENTS WERE NEEDED TO RESOLVE THE DISSECTI

  Patient problems: Vascular Dissection

  MAUDE report 23096453 ↗
• InjuryJul 25, 2025Difficult to Advance; Difficult to Advance

  PATIENT HAD A LEFT TCAR. PROCEDURE WAS PERFORMED IN NORMAL TCAR FASHION. DR. (B)(6) PLACED THE SOFT PORTION THE ENROUTE 0.014 WIRE IN A TORTUOUS ICA. DURING REMOVAL OF THE SDS THE WIRE ADVANCED DISTAL A BIT. WHEN DOING THE COMPLETION ANGIO AFTER THE 3 MIN WASHOUT THERE WAS A NARROWED AREA IN THE DISTAL ICA DISTAL TO THE BEND OF THE ICA. DR. (B)(6) WAS CONTACTED AND DID REVIEW THE IMAGES. PATIENT WOKE UP NERO INTACT. DR. (B)(6) IS PLANNING TO DO AN US TOMORROW TO EVALUATE THE AREA PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. AS REPORTED DEVICE CODES: 1258: DEVICE OPERATES DIFFERENTLY THAN EXPECTED. AS REPORTED PATIENT CODES: 9296: VASOSPASM.

  Patient problems: Vasoconstriction

  MAUDE report 22608453 ↗