ENROUTE Transcarotid Stent FG11815 (REF SR-090740-TCS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00811311021291), received between Aug 6, 2024 and Jul 10, 2026 — classified as 2 deaths, 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P140026); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS NOTED THAT THE PATIENT'S INTERNAL CAROTID ARTERY (ICA) HAD A HEAVY CALCIUM BURDEN AND THE PHYSICIAN ELECTED TO USE A NON-BSC DEVICE TO PREDILATE THE VESSEL. AFTER THE STENT WAS PLACED, THE PHYSICIAN DECIDED IT LOOKED GOOD IN THE ANGIOGRAM AND ELECTED TO NOT POST DILATE. FOUR HOURS POST TCAR PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION AND A STROKE WITH RIGHT EYE VISION CHANGES, LEFT FACIAL DROOP, AND SPEECH ISSUES. ADDITIONALLY, THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED SIGNIFICANT CALCIFIC BURDEN IMPACTING THE VESSEL AND STENT, WITH EVIDENCE THAT THE STENT WAS COMPRESSED AND SUBSEQUENTLY THROMBOSED, RESULTING IN FULL OCCLUSION. THE ICA APPEARED SEVERELY COMPROMISED WITH MINIMAL FLOW AT THE SKULL BASE. THE PATIENT WAS FLOWN TO A DIFFERENT HOSPITAL AND THE STENT WAS EXPLANTED. THE PATIENT'S SYMPTOMS RESOLVED WITHIN 24 HOURS AFTER THE STENT WAS EXPLANTED.

  Patient problems: Blurred Vision; Facial Paralysis; Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Speech Disorder; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 25786571 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST TCAR PROCEDURE, THE PATIENT EXPERIENCED A STROKE AND THROMBOSIS WAS IDENTIFIED. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR AN ACUTE ISCHEMIC STROKE (AIS) THROMBECTOMY.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 25550595 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE POST PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. POST-PROCEDURE, PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED LEFT LEG DEFICIT, AND IMAGING REVEALED AN ISCHEMIC STROKE WITH ANTERIOR CEREBRAL ARTERY (ACA) DISEASE. THE STENT WAS PATENT. NO INTERVENTION WAS PERFORMED, AND THE PATIENT DEMONSTRATED IMPROVING STRENGTH WITH APPROXIMATELY 50% OVERALL IMPROVEMENT. ADDITIONALLY, IT WAS REPORTED THAT THIS PATIENT DEMONSTRATED EXTENSIVE LOW-DENSITY PLAQUE, DESCRIBED AS FRIABLE MATERIAL WITH HOUNSFIELD UNIT VALUES LESS THAN 50, INCLUDING AREAS AS LOW AS 16. LIMITED VISUALIZATION OF THE A2 SEGMENT OF THE RIGHT ANTERIOR CEREBRAL ARTERY WAS ALSO NOTED.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 25498613 ↗
• DeathJun 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient died three days after the procedure.An ENROUTE Transcarotid Stent was selected for use in the left Transcarotid Artery Revascularization (TCAR) procedure. Post procedure, the patient was slow to wake up which was attributed to age and the patient was sent to Post-Anesthesia Care Unit (PACU). Three days after the procedure, it was reported that the patient had passed away. Additionally, it was also reported that the patient had chronic kidney disease (CKD) and chronic obstructive pulmonary disease (COPD). At this time, the patient's cause of death is unknown, and further information is not available.

  Patient problems: Confusion/ Disorientation; Unspecified Tissue Injury

  MAUDE report 25449552 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEMORRHAGIC STROKE AFTER THE PROCEDURE. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING FLOW REVERSAL, AS THE PATIENT'S RIGHT HEMISPHERE WAS FUNCTIONALLY ISOLATED, BLOOD PRESSURES WERE ELEVATED TO AROUND 180MMHG TO SUPPORT FLOW REVERSAL. THE PROCEDURE WAS COMPLETED WITH NO NOTABLE ISSUES. LATER THAT SAME DAY, THE PATIENT DEVELOPED A SUBARACHNOID HEMORRHAGE AND WAS TRANSFERRED TO ANOTHER HOSPITAL. FURTHER IMAGING ALSO REVEALED INTRAVENTRICULAR BLEEDING. THE PHYSICIAN PLACED A VENTRICULAR SHUNT IN THE RIGHT LATERAL VENTRICLE TO TREAT THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemorrhagic Stroke; High Blood Pressure/ Hypertension; Intracranial Hemorrhage

  MAUDE report 24236132 ↗
• DeathJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED FIVE DAYS AFTER THE PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED THAT FIVE DAYS AFTER A TCAR PROCEDURE, THE PATIENT WAS FOUND DEAD AT THEIR HOME. PER THE PHYSICIAN, THE PATIENT APPARENTLY ALSO NEEDED CORONARY ARTERY BYPASS GRAFTING (CABG). AT THIS TIME, THE PATIENT'S CAUSE OF DEATH IS UNKNOWN, AND FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24084749 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A RIGHT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE FINAL ANGIOGRAM REVEALED NO FLOW WAS VISIBLE THROUGH THE STENT AND THROMBUS WAS IDENTIFIED. THE PHYSICIAN ADVANCED A CATHETER BEYOND THE STENT AND TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS DELIVERED FOLLOWED BY DILATION WITH AN UNKNOWN BALLOON. SUBSEQUENT ANGIOGRAPHY WAS TAKEN OF THE CEREBRAL VESSELS AND FLOW WAS RECOGNIZED. POST PROCEDURE, THE PATIENT EXPERIENCED MINOR FACIAL DROOP WITH THE INABILITY TO SQUEEZE LEFT HAND. THE PATIENT WAS SENT FOR IMAGING FOR FURTHER EVALUATION. NO FURTHER INFORMATION WAS PROVIDED TO BOSTON SCIENTIFIC.

  Patient problems: Facial Paralysis; Ischemia Stroke; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 24083350 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING THE PROCEDURE, PLAQUE WAS IDENTIFIED WITHIN THE STENT. THE PHYSICIAN ELECTED TO POST DILATE THE AREA WITH PLAQUE AND COMPLETED THE PROCEDURE. POST TCAR PROCEDURE, THE PATIENT PASSED THE NEUROLOGICAL CHECK BUT EXPERIENCED AN EMBOLIC STROKE FIVE HOURS LATER. IMAGING REVEALED THAT THE PATIENT HAD FRONTAL EMBOLI AND A SMALL ATHEROMA AREA LOCATED WITHIN THE STENT, BUT THE STENT WAS WIDELY PATENT. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE PATIENT WAS NOT DUAL ANTIPLATELET THERAPY (DAPT) COMPLAINT AS ASPIRIN WAS NOT ADMINISTERED. HOWEVER, BASED ON THE P2Y12 INHIBITOR TEST RESULTS, THE PATIENT WAS RESPONSIVE. THE PATIENT SYMPTOMS RESOLVED COMPLETELY WITHIN 48 HOURS OF THE TCAR PROCEDURE.

  Patient problems: Embolism/Embolus; Ischemia Stroke; Paralysis

  MAUDE report 23694935 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN IPSILATERAL EMBOLIC STROKE FOUR DAYS AFTER THE PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO NOTABLE ISSUES. OF NOTE, PLAQUE PROLAPSE WAS NOT RECOGNIZED AT THE TIME OF THE PROCEDURE. FOUR DAYS AFTER TCAR PROCEDURE, THE PATIENT PRESENTED WITH STROKE SYMPTOMS (RIGHT HAND NUMBNESS AND FACIAL APHASIA). THE PATIENT WAS TREATED WITH TNK (TENECTEPLASE). THE FOLLOWING DAY THE PATIENT EXPERIENCED APHASIA, AND THE SYMPTOMS HAD NOT RESOLVED AT THE TIME OF REPORTING. IMAGING PERFORMED REVELED INTRALUMINAL MATERIAL. A P2Y12 RESISTANCE TEST WAS PERFORMED POST PROCEDURE, AND THE PATIENT WAS RESPONSIVE TO P2Y12 PLATELET FUNCTION TEST WITH A PLATELET REACTIVITY UNIT (PRU) OF 123.

  Patient problems: Dysphasia; Embolism/Embolus; Ischemia Stroke; Numbness; Obstruction/Occlusion

  MAUDE report 22956407 ↗
• InjuryJul 23, 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, IMAGING REVEALED THAT THE ENROUTE TRANSCAROTID STENT HAD THROMBOSED. THE PHYSICIAN TESTED FOR PLAVIX RESISTANCE AND ELECTED TO CHANGE THE ANTIPLATELET THERAPY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22584107 ↗
• InjuryJun 11, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE SECOND STENT WAS UNABLE TO CROSS THE LESION, RESULTING IN A CONVERSION TO CAROTID ENDARTERECTOMY (CEA). AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE TARGET LESION WAS HIGHLY CALCIFIED, WITH 85-90% CALCIFICATION AND NO TORTUOSITY. CUTDOWN AND CAROTID ACCESS WAS OBTAINED SUCCESSFULLY WITHOUT COMPLICATIONS, AND THE ARTERIAL SHEATH WAS PLACED IN THE LEFT COMMON CAROTID. AN ENROUTE 0.014 GUIDEWIRE WAS USED TO WIRE THE LESION. A 6X30 NON-BOSTON SCIENTIFIC BALLOON WAS INSERTED OVER THE WIRE AND, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. A WAIST WAS IDENTIFIED WITH THE INITIAL PTA, SO THE 6X30 WAS REMOVED OVER THE WIRE AND A 6X20 BALLOON WAS INSERTED, AND PTA WAS REPEATED. AT THIS TIME, THE 9-7MM X 40MM ENROUTE STENT WAS INSERTED OVER THE WIRE. THE STENT WOULD NOT ADVANCE THROUGH THE LESION. AN ADDITIONAL ENROUTE 0.014 GUIDEWIRE WAS INSERTED AS A BUDDY WIRE BESIDE THE EXISTING WIRE. THE STENT WAS AGAIN ADVANCED AND YET AGAIN DID NOT PASS THROUGH THE LESION. MULTIPLE ATTEMPTS TO ADVANCE THE STENT THROUGH THE LESION WERE MADE WITHOUT SUCCESS. THE BUDDY WIRE WAS THEN R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185363 ↗
• MalfunctionJun 10, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE STENT TIP WAS DAMAGED. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE TARGET LESION WAS HIGHLY CALCIFIED, WITH 85-90% CALCIFICATION AND NO TORTUOSITY. CUTDOWN AND CAROTID ACCESS WAS OBTAINED SUCCESSFULLY WITHOUT COMPLICATIONS, AND THE ARTERIAL SHEATH WAS PLACED IN THE LEFT COMMON CAROTID. AN ENROUTE 0.014 GUIDEWIRE WAS USED TO WIRE THE LESION. A 6X30 NON-BOSTON SCIENTIFIC BALLOON WAS INSERTED OVER THE WIRE AND, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. A WAIST WAS IDENTIFIED WITH THE INITIAL PTA, SO THE 6X30 WAS REMOVED OVER THE WIRE AND AN UNKNOWN 6X20 BALLOON WAS INSERTED, AND PTA WAS REPEATED. AT THIS TIME, THE 9-7MM X 40MM ENROUTE STENT WAS INSERTED OVER THE WIRE. THE STENT WOULD NOT ADVANCE THROUGH THE LESION. AN ADDITIONAL ENROUTE 0.014 GUIDEWIRE WAS INSERTED AS A BUDDY WIRE BESIDE THE EXISTING WIRE. THE STENT WAS AGAIN ADVANCED AND YET AGAIN DID NOT PASS THROUGH THE LESION. MULTIPLE ATTEMPTS TO ADVANCE THE STENT THROUGH THE LESION WERE MADE WITHOUT SUCCESS. THE BUDDY WIRE WAS THEN REMOVED. THE STENT DELIVERY SYSTEM WAS INSERTED AND ATTEMPTED TO ADVANCE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181599 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION WAS OBSERVED IN THE POST-STENTING ANGIOGRAM. THE PERFORATION REQUIRED AN ADDITIONAL STENT BEING PLACED. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PATIENT PRESENTED AS ASYMPTOMATIC. AFTER PERFORMING THE TCAR ACCORDING TO THE IFU, A POST-STENTING ANGIOGRAM REVEALED BLUSHING OUTSIDE THE 9-7X40 ENROUTE STENT. UPON SEEING THIS, A NON-BOSTON SCIENTIFIC BALLOON WAS INFLATED NOMINALLY AT THE AREA WHERE BLUSHING APPEARED ON THE ANGIOGRAM. AFTER LEAVING THE BALLOON INFLATED FOR 5 MINUTES, BLUSHING WAS VISUALIZED IN THE ANGIOGRAM POST-BALLOON INFLATION. THE NON-BOSTON SCIENTIFIC BALLOON WAS INFLATED AT MULTIPLE LOCATIONS WITHIN THE STENT FOR 2-4 MINUTES EACH TO ATTEMPT TO TAMPONADE THE AREA OF CONCERN. AT THIS TIME, IT WAS DETERMINED THAT AN ADDITIONAL STENT WAS NEEDED, AND A NON-BOSTON SCIENTIFIC COVERED STENT WAS PLACED WITHIN THE 9-7X40 ENROUTE STENT. BLUSHING WAS AGAIN OBSERVED ON THE POST-STENT PLACEMENT ANGIOGRAM. THE NON-BOSTON SCIENTIFIC BALLOON WAS INSERTED INTO THE STENTS TO HELP TAMPONADE THE NEWLY DEPLOYED STENT. BLUSHING WAS OBSERVED AFTER BALLOONING. AN 8MM B

  Patient problems: Perforation of Vessels

  MAUDE report 22092118 ↗
• InjuryFeb 11, 2025Material Deformation; Material Deformation

  ON FEBRUARY 03, 2025, A MEDWATCH REPORT#: (B)(4) WAS RECEIVED VIA EMAIL. THE FOLLOWING INFORMATION WAS PROVIDED ON THE MEDWATCH REPORT: STENT FAILURE / PATIENT NEED TO RETURN TO SURGERY - AND LEFT EXPLANT OF INTERNAL CAROTID ARTERY STENT, CAROTID ARTERY ENDARTERECTOMY WITH BOVINE PERICARDIAL PATCH ANGIOPLASTY. IT WAS REPORTED THAT AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED STROKE SYMPTOMS AND THE STENT WAS IDENTIFIED TO BE DEFORMED. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND PERFORM A CAROTID ARTERY ENDARTERECTOMY (CEA) WITH A BOVINE PERICARDIAL PATCH ANGIOPLASTY. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED STROKE EVENT IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE OR NON-COMPLIANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE, HOWEVER, THIS EVENT WILL BE REPORTED FOR THE ENROUTE TRANSCAROTID STENT SYSTEM (TSS) OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: Stroke/CVA

  MAUDE report 21360647 ↗
• InjuryJan 31, 2025

  STENT FAILURE / PATIENT NEED TO RETURN TO SURGERY, AND LEFT EXPLANT OF INTERNAL CAROTID ARTERY STENT, CAROTID ARTERY ENDARTERECTOMY WITH BOVINE PERICARDIAL PATCH ANGIOPLASTY.

  Patient problems: Insufficient Information

  MAUDE report 21282438 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED LEFT-SIDED UPPER EXTREMITY WEAKNESS AND APHASIA. IMAGING REVEALED A THROMBOSED STENT WITH THE THROMBUS EXTENDING DISTAL TO THE STENT. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY, WHERE THEY UNDERWENT A THROMBECTOMY. THE PATIENT'S UPPER EXTREMITY WEAKNESS HAS RESOLVED, BUT THE APHASIA HAS NOT, AND THE PATIENT IS CURRENTLY IN HOSPICE CARE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD AN UNDERLYING CONDITION, BUT THE CONDITION IS UNKNOWN AT THIS TIME. AT THIS TIME, IT IS UNKNOWN IF THE REPORTED EVENT OF THROMBOSIS AND AN EMBOLIC STROKE IS RELATED TO PROCEDURAL ISSUES, PATIENT RESISTANCE TO MEDICATION, OR A SILK ROAD MEDICAL DEVICE FAILURE, HENCE, THE EVENT WILL BE REPORTED OUT OF ABUNDANCE OF CAUTION.

  Patient problems: Dysphasia; Ischemia Stroke; Muscle Weakness/Atrophy; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21174817 ↗
• MalfunctionAug 6, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, UPON DEPLOYMENT OF THE ENROUTE TRANSCAROTID STENT SYSTEM (TSS), THE STENT DELIVERY SYSTEM (SDS) COULD NOT BE REMOVED AS IT WAS STUCK ON A STENT STRUT DUE TO HARD CALCIUM . THE PHYSICIAN USED INTERVENTIONAL WIRES AND BALLOON DILATED THE TIGHT PORTION OF THE STENT TO REMOVE THE SDS SUCCESSFULLY, HOWEVER, ATTEMPTS TO FURTHER DILATE THE STENT WERE UNSUCCESSFUL AS THE STENT WAS COMPRESSED BY CALCIUM. THE PHYSICIAN ELECTED TO EXPLANT THE STENT AND CONVERTED THE PROCEDURE TO CAROTID ENDARTERECTOMY (CEA). THERE WERE NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923676 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140026. One submission often covers many models, so check the product and lot details in each record.

• Z-1146-2021 · Jan 13, 2021 · Terminated
  ENROUTE Transcarotid Stent System REF SR-XXYY-CS