ENROUTE Transcarotid Neuroprotection System SR-200-NPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00811311020744), received between Jul 22, 2016 and Jun 1, 2026 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

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 18 most recent of 18 reports, 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 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A TCAR PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ENGAGING THE EXTERNAL CAROTID DUE TO THE SIGNIFICANT ANGLE COMING OFF OF THE COMMON. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN STOPPED. THE GUIDEWIRE WAS ADVANCED TO JUST SHORT OF THE BIFURCATION, AND THE MICROPUNCTURE SHEATH WAS EXCHANGED WITH THE NPS ARTERIAL SHEATH. TWO VIEWS WERE TAKEN, BUT NO DISSECTION WAS VISUALIZED, AND .014" WIRE WAS ADVANCED INTO RIGHT INTERNAL CAROTID ARTERY. WIRE QUICKLY BEGAN TO PROLAPSE IN RIGHT INTERNAL CAROTID ARTERY AND DISSECTION WAS REALIZED. SEVERAL ATTEMPTS WERE MADE TO PULL ARTERIAL SHEATH TIP BACK AND WORK AROUND DISSECTION TO NO AVAIL. DECISION WAS MADE TO CONVERT TO CEA. PATIENT HAD SUCCESSFUL CEA, AND CAME OUT OF SURGERY WITH ALL VITALS NORMAL AND NEURO INTACT.

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 9650274 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT TCAR PROCEDURE. THE ARTERIAL SHEATH WAS ADVANCED OVER THE GUIDEWIRE AND WENT IN SMOOTHLY UNDER ANGIOGRAPHY, WITH WIRE NEVER ADVANCING, AND WAS THEN SUTURED INTO PLACE. DISSECTION NOTED AT THE TIP OF THE ARTERIAL SHEATH WHEN TAKING 2 VIEWS. ATTEMPTS WERE MADE TO PULL BACK ARTERIAL SHEATH TO ALLOW WIRE INTO TRUE LUMEN. ORIGINAL ACCESS POINT WAS CLOSED, AND THE PHYSICIAN ATTEMPTED THE PROCESS AGAIN. ANGIO REVEALED DISSECTION, BUT MD DID NOT FEEL HE WAS IN TRUE LUMEN AND DID NOT WISH TO TRY AND PASS WIRES AT THIS TIME. DECISION WAS MADE TO ABANDON TRANSCAROTID REVASCULARIZATION PROCEDURE, AND CONVERT TREATMENT TO CEA. PATIENT DID WELL AND WOKE UP POST PROCEDURE NEUROLOGICALLY INTACT.

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 9650068 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSCAROTID REVASCULARIZATION PROCEDURE ON (B)(6) 2016. THE PATIENT EXPERIENCED A DISSECTION AFTER MULTIPLE ATTEMPTS WERE MADE TO RE-ACCESS THE ARTERY. THE PHYSICIAN CONVERTED TO A CEA (CAROTID ENDARTERECTOMY). NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 9645244 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A TRANSCAROTID REVASCULARIZATION PROCEDURE ON (B)(6) 2016. THE PATIENT EXPERIENCED A DISSECTION OF THE COMMON CAROTID ARTERY (CCA) BACKWALL DURING INTRODUCTION OF THE NEUROPROTECTION SYSTEM. THE DISSECTION WAS SUCCESSFULLY TREATED WITH THE PLACEMENT OF A SECOND CAROTID STENT. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 9640175 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSCAROTID REVASCULARIZATION PROCEDURE ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN IPSILATERAL STROKE AND APHASIA ON THE EVENING OF TCAR PROCEDURE. AN MRI WAS PERFORMED WHICH FOUND A SMALL LEFT FRONTAL CORTICAL INFARCTION. A NEURO CONSULTATION WAS PERFORMED, IN WHICH SPEECH THERAPY AND PHYSICAL THERAPY WERE RECOMMENDED. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Brain Injury; Patient Problem/Medical Problem

  MAUDE report 9639676 ↗
• InjuryMay 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CIRCUMFERENTIAL ATHEROMA AT CLAMP/STICK ZONE THEREFORE ACCESSED VESSEL 1 CM DISTAL TO ATHEROMA .J-TIP .035 4 CM WITHIN VESSEL. ENROUTE NPS ARTERIAL SHEATH INTRODUCED UNDER FLUORO MET RESISTANCE TOLD PHYSICIAN TO STOP. SMALL DISTAL DISSECTION FLAP NOTED IN DISTAL RCCA. RICA STENOSIS TREATED WITH SRM 0640 ENROUTE SDS AND DISSECTION FLAP TACKED DOWN WITH SRM 0930 ENROUTE SDS.

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 6582693 ↗
• InjuryOct 5, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER INTRODUCTION OF THE ENROUTE NEUROPROTECTION SYSTEM (NPS), IT WAS NOTED THE FLUSHING ARM WOULD NOT ASPIRATE WITH EASE AND HAD SOME AIR. IT WAS MENTIONED AS IT SEEMED AS IF IT WAS ON THE BACK WALL. PHYSICIAN RETRACTED THE SHEATH A SHORT DISTANCE AND THE SHEATH ASPIRATED WITH EASE AND WAS ABLE TO FLUSH. ON SUBSEQUENT ANGIOGRAM, DISSECTION WITH EXTRAVASATION NOTED IN THE LCCA. SHEATH WAS REMOVED AND VESSEL CLAMPED WHILE SOME CARE WAS GIVEN TO ARTERIOTOMY BY PHYSICIAN THEN THE SHEATH REPLACED. SHEATH WAS ASPIRATED AND FLUSHED AND ANGIOGRAM SHOWED BETTER LUMEN FILLING WITH DISSECTION AND EXTRAVASATION. PHYSICIAN FELT WE COULD STENT OVER THE FLAP AND PROCEDURE CONTINUED. NPS CONNECTED AND FLOW REVERSAL INITIATION PER ROUTINE. WIRE PLACED ACROSS LESION. PRE DILATION, STENT AND POST DILATATION PERFORMED. LUMEN VISUALIZATION VASTLY IMPROVED BUT STILL SOME STAINING. SECOND STENT PLACED OVER LAPPING STENT UP TO THE EDGE OF THE NPS SHEATH. ANGIOGRAM PERFORMED. PROCEDURE COMPLETED. DRAIN PLACED AND PROTAMINE GIVEN. PATIENT EXTUBATED INTACT.

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 6001956 ↗
• InjuryJul 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISSECTION WAS NOTED ON THE SECOND ANGIOGRAM THAT CONFIRMED TIP PLACEMENT DISTAL TO THE ARTERIAL SHEATH TIP. THE DISSECTION MOST LIKELY OCCURED DURING 0.035" WIRE AND SRM ARTERIAL SHEATH INTRODUCTION TO THE CCA (COMMON CAROTID ARTERY). THE DISSECTION WAS A NON-FLOW LIMITING DISSECTION. THE TARGET LESION WAS TREATED SUCCESSFULLY. THE DISSECTION WAS TREATED WITH AN 8X20 BALLOON INFLATION AND AN 8X30 ENROUTE TRANSCAROTID STENT. PATIENT WAS AWAKE POST PROCEDURE AND THERE WERE NO NEUROLOGICAL SYMPTOMS.

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 5815660 ↗