ENROUTE Transcarotid Neuroprotection SystemRecalls & reported problems across all models

We found 2 models of ENROUTE Transcarotid Neuroprotection System by Silk Road Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 706 adverse event reports in the FDA's MAUDE database, received between Jul 22, 2016 and Jun 1, 2026 — classified as 4 deaths, 693 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

ENROUTE Transcarotid Neuroprotection System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 9, 2026Class IOpen, Classified

   Potential for arterial sheath tip separation or partial tip separation during use.

   Z-2977-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported ENROUTE Transcarotid Neuroprotection System problems

ENROUTE Transcarotid Neuroprotection System models

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

• ENROUTE Transcarotid Neuroprotection System FG12522

  Temporary Carotid Catheter For Embolic Capture
  1 recall4 deaths688 reports
• ENROUTE Transcarotid Neuroprotection System SR-200-NPS

  Temporary Carotid Catheter For Embolic Capture
  18 reports

Recent ENROUTE Transcarotid Neuroprotection System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Difficult or Delayed Positioning; Insufficient Flow or Under Infusion; Air/Gas in Device

  IT WAS REPORTED THAT THERE WAS INADEQUATE FLOW WITHIN IN THE DEVICE. THE PATIENT PRESENTED AS SYMPTOMATIC FOR A RIGHT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE. DURING THE PROCEDURE, A FLUSH BOLUS WAS ADMINISTERED TO CONFIRM REVERSE FLOW; HOWEVER, ONLY MINIMAL FLOW WAS OBSERVED. THE STOPCOCKS, TUBING, AND ARTERIAL SHEATH POSITION WERE VERIFIED, AND BLOOD PRESSURE WAS MAINTAINED BETWEEN 140 TO 160 MMHG. CHALLENGES IN ACHIEVING ADEQUATE FLOW REVERSAL WERE SUSPECTED TO BE RELATED TO FEMORAL SHEATH PLACEMENT IN THE FEMORAL ARTERY RATHER THAN THE FEMORAL VEIN, RESULTING IN AN INADEQUATE PRESSURE GRADIENT. VENOUS SHEATH ACCESS WAS PERFORMED BY A RESIDENT AT THE DIRECTION OF THE PHYSICIAN; HOWEVER, IT IS UNKNOWN WHETHER THE ACCESS WAS ARTERIAL OR VENOUS. THE PHYSICIAN ELECTED TO CONTINUE THE PROCEDURE WITHOUT EXCHANGING THE SYSTEM. FINAL ANGIOGRAPHY SUGGESTED THE PRESENCE OF A SMALL AIR BUBBLE AND A POSSIBLE THROMBUS AT THE DISTAL EDGE OF THE STENT. IMAGING ANGLES WERE ADJUSTED TO ASSESS FOR DISSECTION; HOWEVER, NONE WAS IDENTIFIED. DURING THIS TIME, AIR WAS NOTED WITHIN THE NPS TUBING AND ARTERIAL SHEATH. RE

  Patient problems: Dysphasia; Transient Ischemic Attack

  MAUDE report 25356200 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE DURING THE PROCEDURE. THE PATIENT PRESENTED FOR A TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE. THE PATIENT EXPERIENCED A STROKE OF UNKNOWN ETIOLOGY DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED DESPITE REQUEST BY BOSTON SCIENTIFIC (BSC).

  Patient problems: Stroke/CVA

  MAUDE report 25140098 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE DURING THE PROCEDURE. THE PATIENT PRESENTED FOR A TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE. THE PATIENT EXPERIENCED A STROKE OF UNKNOWN ETIOLOGY DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED DESPITE REQUEST BY BOSTON SCIENTIFIC (BSC).

  Patient problems: Stroke/CVA

  MAUDE report 25140065 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE AFTER THE PROCEDURE. THE PATIENT PRESENTED FOR A TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE. THE PATIENT EXPERIENCED A STROKE OF UNKNOWN ETIOLOGY AFTER THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED DESPITE REQUEST BY BOSTON SCIENTIFIC (BSC).

  Patient problems: Stroke/CVA

  MAUDE report 25140047 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE AFTER THE PROCEDURE. THE PATIENT PRESENTED FOR A TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE. THE PATIENT EXPERIENCED A STROKE OF UNKNOWN ETIOLOGY AFTER THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED DESPITE REQUEST BY BOSTON SCIENTIFIC (BSC).

  Patient problems: Stroke/CVA

  MAUDE report 25140045 ↗
• InjuryJun 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ARTERIAL SHEATH TIP BROKE OFF DURING THE INITIAL TCAR PROCEDURE, REQUIRING ADDITIONAL SURGICAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE THAT TOOK PLACE ON (B)(6) 2024. DURING THE PROCEDURE, THE BLACK MARKER TIP OF THE ARTERIAL SHEATH OF THE NPS BROKE OFF WITHIN THE PATIENT. THE PHYSICIAN STATED THAT HE MUST HAVE CLAMPED THE TIP OF THE SHEATH, RESULTING IN THE SEPARATION. FURTHER, IT WAS NOTED THAT THERE WAS SOME FRAYING OR UNRAVELING OF THE SPRING LIKE STRUCTURE ON THE OUTSIDE OF THE SHEATH. PER THE PHYSICIAN, POST-PROCEDURE IMAGING WAS UNABLE TO VISUALIZE THE BLACK TIP OF THE SHEATH WITHIN THE PATIENT. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RECURRENT STENOSIS OF PRIOR LEFT TCAR. EXAMINATION OF COMPUTED TOMOGRAPHY (CT) IMAGES FROM (B)(6) 2025 REVEALED WHAT APPEARED TO BE THE ARTERIAL SHEATH TIP OF THE NPS EMBOLIZED WITHIN THE STENT. IT WAS SUSPECTED THAT THE EMBOLUS WITHIN THE STENT COULD BE RECURRENT RESTENOSIS AND CALCIFICATION. AS A RESULT OF THE EMBOLUS, THE PATIENT UNDERWENT A BYPASS SURGERY ON (B)(6) 2025. AS TH

  Patient problems: Calcium Deposits/Calcification; Foreign Body In Patient; Restenosis

  MAUDE report 22244006 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EMBOLIC STROKE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN A LEFT TRANSCAROTID REVASCULARIZATION (TCAR) PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS PLANNED WITH NO DEVICE ISSUES. FOLLOWING THE PROCEDURE, THE PATIENT INITIALLY WOKE UP UNABLE TO MOVE HIS RIGHT LIMBS. BY THE TIME HE REACHED THE POST-ANESTHESIA CARE UNIT (PACU), HE HAD REGAINED MOVEMENT IN BOTH RIGHT LIMBS. THE FOLLOWING MORNING, HE EXHIBITED SLIGHT ALTERED MENTAL STATUS (AMS) BUT WAS ABLE TO FOLLOW COMMANDS AND MOVE ALL LIMBS. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Cognitive Changes; Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 22196100 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN THE RIGHT SIDED TCAR PROCEDURE. PRIOR TO THE PROCEDURE, THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT) HOWEVER, THE PATIENT WAS SWITCHED TO TICAGRELOR PRIOR TO THE PROCEDURE BASED ON THE RESULT OF THE P2Y12 PLATELET FUNCTION TEST. POST-PROCEDURE, THE PATIENT BECAME COMBATIVE, WAS UNABLE TO FOLLOW COMMANDS, AND EXPERIENCED DIFFICULTY COMMUNICATING. MAGNETIC RESONANCE IMAGING (MRI) REVEALED AN EMBOLIC PARIETAL AND FRONTAL LOBE STROKE. THE PHYSICIAN REPORTED THAT THE STENT WAS PATENT, AND THE PATIENT'S SYMPTOMS HAVE COMPLETELY RESOLVED. NO INTERVENTION WAS PERFORMED.

  Patient problems: Dysphasia; Emotional Changes; Ischemia Stroke

  MAUDE report 22195226 ↗
• InjuryJun 11, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT A DISSECTION OCCURRED RESULTING IN ADDITIONAL SURGICAL INTERVENTION. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM WAS SELECTED FOR USE IN THE LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING INSERTION OF THE ARTERIAL SHEATH, THE J-WIRE CAME BACK, AND IMAGING REVEALED A DISSECTION FROM INSERTION AREA TO BIFURCATION. ATTEMPTS WERE MADE TO ADVANCE THE 0.014 GUIDEWIRE PAST THE BIFURCATION BUT WAS UNSUCCESSFUL. THE WIRE AND BALLOON WERE REMOVED, AND THE ARTERIAL SHEATH WAS SLIGHTLY PULLED AND ADJUSTED BUT WAS UNABLE TO ADVANCE THE GUIDEWIRE. THE PROCEDURE WAS CONVERTED TO A CAROTID ENDARTERECTOMY (CEA) AND THE PATIENT WOKE UP NEUROLOGICALLY INTACT.

  Patient problems: Vascular Dissection

  MAUDE report 22183626 ↗
• InjuryMay 22, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EMBOLIC STROKE AFTER THE PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PATIENT PRESENTED AS SYMPTOMATIC AND WAS DAPT COMPLIANT. THE TCAR PROCEDURE WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND FOLLOWING PROTOCOL. DURING THE PROCEDURE, REVERSE FLOW WITH THE NPS SEEMED SLOWER THAN NORMAL, BUT NOT CONCERNING, AS THE PHYSICIAN MENTIONED THAT THE VEIN COULD HAVE HAD DISEASE. MINUTES AFTER THE POST-PROCEDURE NEUROLOGICAL CHECK, THE PATIENT WAS UNABLE TO MOVE HIS LEFT HAND. THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED AN EMBOLIC CEREBROVASCULAR ACCIDENT (CVA). THE BLOOD PRESSURE OF THE PATIENT WAS WITHIN PARAMETERS. NO INTERVENTION WAS TAKEN AS A RESULT OF THE EVENT.

  Patient problems: Ischemia Stroke; Paralysis

  MAUDE report 22069382 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHORTLY AFTER THE COMPLETION OF A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT WOKE UP AND WAS UNABLE TO RAISE THEIR ARM ON COMMAND. IMAGING PERFORMED REVEALED AN EMBOLIC STROKE. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT), HOWEVER, A P2Y12 PLATELET FUNCTION TEST WAS NOT PERFORMED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION PERFORMED, AND THE PATIENT HAS NOT MADE A COMPLETE RECOVERY. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT IS DUE TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO MEDICATION OR A SILK ROAD MEDICAL DEVICE, HENCE IT WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 21903337 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER COMPLETION OF A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT WAS SLOW TO WAKE UP AND EXPERIENCED LEFT SIDE WEAKNESS WITH FACIAL DROOP. IT WAS ALSO NOTED THAT THE PATIENT'S PULSE OXIMETER DROPPED ON RIGHT SIDE AND THE PATIENT ALSO EXPERIENCED BRADYCARDIA FOR A SHORT DURATION DURING THE PROCEDURE. THE PATIENT'S SYMPTOMS HAVE RESOLVED AND IS BACK TO BASELINE. ADDITIONAL INFORMATION INDICATED THAT THERE WAS SUSPICION OF PATIENT HAVING AN ISOLATED HEMISPHERE, BUT WAS NOT CONFIRMED AND THE ETIOLOGY OF THE STROKE IS UNKNOWN AT THIS TIME AT THIS TIME IT IS UNCLEAR IF THE REPORTED EVENT IS DUE TO PATIENT'S RESISTANCE TO MEDICATION, PROCEDURAL COMPLICATIONS OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 21900443 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, AN INTRAMURAL HEMATOMA OCCURRED, POSSIBLY WITH THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS). THE PHYSICIAN PLACED AN UNPLANNED ADDITIONAL STENT TO ADDRESS THE HEMATOMA. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Hematoma

  MAUDE report 21780284 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT FAILED THE POST PROCEDURE NEUROLOGICAL CHECK AND WAS UNABLE TO MOVE THEIR RIGHT HAND. THE PATIENT WAS ON PLAVIX AND ASPIRIN BUT NOT ON STATINS DUE TO STATIN ALLERGIES. ADDITIONAL INFORMATION STATED THAT EMBOLI WAS NOTED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), CONTRALATERAL TO THE TREATMENT SIDE. THE PHYSICIAN ELECTED TO PERFORM A THROMBECTOMY AND THE PATIENT HAS NOT RETURNED TO BASELINE. IT WAS DETERMINED BY THE PHYSICIAN THAT THE EVENT WAS DUE TO THE PATIENT'S UNDERLYING CONDITION OF ATRIAL FIBRILLATION. HOWEVER, THE SILK ROAD MEDICAL EXECUTIVE MEDICAL DIRECTOR REVIEWED THE MAGNETIC RESONANCE IMAGING (MRI) ON (B)(6) 2025 AND NOTED THAT NEW WHITE LESIONS WERE PRESENT IN THE CEREBELLUM, IN WATERSHED ZONES, AND THE LEFT MOTOR STRIP. THE CEREBELLUM IS SUPPLIED BY THE VERTEBROBASILAR ARTERIES WHICH ARE NOT INTERACTED WITH DURING THE TCAR PROCEDURE, HENCE THE EMBOLI IN THE CEREBELLUM ARE UNRELATED TO THE PROCEDURE. THE MOTOR STRIP IS SUPPLIED BY THE CAROTID ARTERIES, AND THE APPROXIMATE AGE OF THE LESIONS IN THE MOTOR STRIP INDICATED THAT THEY MAY BE RELATED TO THE TIMING OF THE TCAR

  Patient problems: Atrial Fibrillation; Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 21756795 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ARTERIAL SHEATH OF THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) CAUSED A DISSECTION. THE PHYSICIAN CONVERTED THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA) AND USED A GORE GRAFT TO REPAIR THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21703326 ↗

Other Silk Road Medical, Inc. products

• ENROUTE Transcarotid Stent14 models · 303 reports · 1 recall
• ENROUTE .014" Guidewire2 models · 230 reports