XACT™ 82091-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648010279), received between Aug 9, 2017 and Nov 26, 2025 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED INTERNAL CAROTID ARTERY. THE 8X30X136 XACT STENT WAS ADVANCED TO THE TARGET LESION AND WHEN ATTEMPTING TO DEPLOY THE STENT COMPLETELY FAILED TO DEPLOYED. THERE WAS NO RESISTANCE FELT; HOWEVER, IT WAS NOTED THAT THE DEVICE FELT LOOSER THAN USUAL WHEN ATTEMPTING TO DEPLOY. THEREFORE, ANOTHER UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. PER DEVICE ANALYSIS A SEPARATION WAS NOTED AT THE SHEATH-SHAFT BOND AREA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661071 ↗
• InjuryApr 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, MILDLY TORTUOUS RIGHT INTERNAL CAROTID ARTERY. THE 8X30X136 XACT STENT WAS IMPLANTED WITHOUT ISSUE. HOWEVER, POST-PROCEDURE THE SAME DAY, THE STENT COLLAPSED CAUSING AN OCCLUSION. THE PATIENT WAS GIVEN BLOOD PRESSURE MEDICATION TO INCREASE BLOOD PRESSURE AND CONTRALATERAL FLOW. NO FURTHER TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21766999 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN INTERNAL CAROTID ARTERY THAT IS 99% STENOSED. A 4.0X20MM VIATRAC BALLOON WAS USED TO PRE-DILATED THE LESION SUCCESSFULLY. AN EMBOSHIELD NAV6 AND A 8-6X30MM XACT STENT, WERE ALSO USED SUCCESSFULLY, HOWEVER, THE PATIENT WAS NOTED TO EXPERIENCE LEFT ARM WEAKNESS POST PROCEDURE. THE SYMPTOM SPONTANEOUSLY RESOLVED AFTER CAT SCAN WAS PERFORMED WITH GREAT RESULTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Paresis

  MAUDE report 21462861 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT COMMON CAROTID ARTERY THAT IS 90% STENOSED. A 8TX30X136 XACT STENT WAS IMPLANTED WITHOUT ISSUE; HOWEVER, ABOUT 30 MINUTES POST PROCEDURE, THE PATIENT SUFFERED A STROKE. THE STENT IMPLANT WAS OBSERVED TO BE FULLY THROMBOSED. THE PATIENT WAS BROUGHT BACK INTO THE PROCEDURE ROOM AND THROMBECTOMY WAS PERFORMED AND 20 MINUTES LATER THE STENT THROMBOSED AGAIN. ADDITIONAL THROMBECTOMY WAS PERFORMED WITH SAME MODALITY SUCCESSFULLY. MEDICATION WAS PROVIDED FOR THE STROKE. THERE WAS NO ADVERSE PATIENT SEQUELA; HOWEVER, PATIENT WAS DISCHARGED TWO DAYS LATER WITH NO NEUROLOGICAL DEFICITS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 21211649 ↗
• MalfunctionNov 26, 2024Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION BUT THE THUMBWHEEL COULD NOT BE TURNED AND THE STENT PARTIALLY DEPLOYED. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788641 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE RIGHT INTERNAL CAROTID ARTERY DUE TO VISION LOSS THAT THE PATIENT WAS EXPERIENCING ON THE LEFT SIDE, INDICATING AN ISSUE IN THE RIGHT ARTERY WITH 99% STENOSIS, NONE CALCIFICATION AND NONE TORTUOSITY. AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED AND THE FIRST XACT STENT (LOT 2121461) WAS IMPLANTED BY DIRECT STENTING IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITHOUT ISSUE. THE EMBOSHIELD NAV6 WAS REMOVED. AT THIS TIME IT WAS NOTED THAT THE PATIENT HAD LOST MOVEMENT IN THE FOOT AND LEG ON THE RIGHT SIDE AS WELL AS A LOSS OF SPEECH. A CLOT HAD FORMED IN THE LEFT ICA/EXTERNAL CAROTID ARTERY. AN EMBOSHIELD NAV6 (LOT 3031661) WAS ATTEMPTED TO BE ADVANCED BUT COULD NOT PASS SO BALLOON DILATATION WAS PERFORMED WITH A VIATRAC BALLOON AND THEN THE EMBOSHIELD NAV6 WAS ABLE TO BE ADVANCED TO THE DESIRED LOCATION. THEN AN XACT STENT WAS PLACED IN THE LEFT ICA AND POST DILATED WITH THE VIATRAC BALLOON. FOUR MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED. FLOW TO THE BRAIN WAS RESTORED. THE STENTS ARE PATENT. THERE WAS NO DIAGNOSIS OF STROKE OR TRANSIENT ISCHEMIC ATTACK. THE PATIENT REMAINED HOSPITALIZED I

  Patient problems: Paresis; Thrombosis/Thrombus

  MAUDE report 17144298 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 8 X 30MM XACT STENT WAS SUCCESSFULLY IMPLANTED TO TREAT THE 80% STENOSED LESION IN THE TORTUOUS RIGHT INTERNAL CAROTID ARTERY. THE PATIENT WAS DISCHARGED. HOWEVER, ON (B)(6) 2022, THE PATIENT WAS READMITTED TO THE EMERGENCY DEPARTMENT WITH SYMPTOMS OF A STROKE. THE STENT WAS NO LONGER PATENT AS THERE WAS THROMBUS FROM THE RIGHT COMMON CAROTID ARTERY TO THE INTERNAL CAROTID ARTERY. LAB TESTS WERE PERFORMED AND THE PATIENT WAS TREATED WITH PLAVIX. HOWEVER, THE PATIENT DID NOT RESPOND TO THE MEDICATION AND THE THROMBUS REMAINED UNTREATED. THE PATIENT WAS REFERRED TO HOSPICE. NO ADDITIONAL INFORMATION WAS GIVEN.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 14079084 ↗
• InjuryNov 17, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT INTERNAL CAROTID ARTERY. AN EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM WAS FIRST DEPLOYED WITHOUT REPORTED ISSUE. THE XACT CAROTID STENT SYSTEM WAS ATTEMPTED BUT COULD NOT CROSS THE LESION DUE TO THE CALCIFICATION. IT WAS TAKEN OUT AND PRE-DILATATION WAS PERFORMED WITH A VIATRAC BALLOON DILATATION CATHETER (BDC) WITHOUT REPORTED ISSUE. THE SAME XACT STENT DELIVERY SYSTEM WAS ADVANCED AND WAS DEPLOYED. THE STATUS OF THE STENT IS KNOWN TO BE PATENT. AT THIS POINT, ANGIOGRAM WAS PERFORMED AND WHEN THE CONTRAST WAS INJECTED, AIR BUBBLES WERE SEEN IN THE VESSEL. THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) AND COULD NOT SPEAK AND HAD DECREASED STRENGTH WITH HER RIGHT HAND. THE EMBOSHIELD NAV6 FILTER WAS REMOVED. AFTER APPROXIMATELY 5-10 MINUTES, THE SYMPTOMS RESOLVED. NO TREATMENT WAS REPORTED. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AFTER LEAVING THE CATH LAB. THE PATIENT HAD HOSPITALIZATION BUT IT WAS ORIGINALLY PLANNED. THE NEXT DAY THE PATIENT'S SYMPTOMS WERE BACK TO BASELINE. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Transient Ischemic Attack

  MAUDE report 12828804 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS INTERNAL CAROTID ARTERY. AN EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM WAS ADVANCED AND DEPLOYED. A 4X20 MM VIATRAC DILATATION CATHETER WAS USED FOR PRE-DILATATION. A XACT 8TX30X136 CAROTID STENT SYSTEM WAS ADVANCED AND DEPLOYED WITHOUT ANY ISSUE IN THE INTERNAL CAROTID ARTERY. A 5X20 MM VIATRAC DILATATION CATHETER WAS USED FOR POST DILATATION AND THE EMBOSHIELD NAV 6 WAS RETRIEVED WITHOUT ISSUE. APPROXIMATELY, TWENTY-FIVE MINUTES AFTER THE PROCEDURE, WHEN THE PATIENT WAS IN INTENSIVE CARE UNIT (ICU); THE PATIENT EXPERIENCED LEFT SIDE FACIAL DROOPING AND LEFT SIDE LEG WEAKNESS. THE PATIENT HAD A STROKE, NO FLOW WAS OBSERVED IN THE INTERNAL CAROTID ARTERY WHERE THE XACT STENT WAS IMPLANTED. THE PATIENT WAS TRANSFERRED TO A NEIGHBORING HOSPITAL THAT TREATS ACUTE STROKE PATIENTS. TISSUE PLASMINOGEN ACTIVATOR AND ACUTE STROKE INTERVENTION WAS PERFORMED, A CLOT WAS REMOVED FROM XACT STENT WITH A NON-ABBOTT CATHETER AND ADDITIONAL BALLOONING WAS PERFORMED WITH 6.0 X 20 VIATRAC BALLOON. THE PATIENT WAS KEPT OVERNIGHT IN THE ICU. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 11936351 ↗
• MalfunctionAug 24, 2020Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT AFTER SUCCESSFUL IMPLANTATION OF THE XACT CAROTID STENT, THE DELIVERY SYSTEM KINKED DURING REMOVAL. REPORTEDLY, THE GUIDE WIRE COULD BE SEEN THROUGH THE DEVICE AS THE CATHETER WAS BENT. THE CATHETER WAS NOT SEPARATED INTO TWO PIECES AND THERE WAS NO RESISTANCE NOTED DURING REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE SHAFT OF THE XACT STENT WAS SEPARATED FROM THE PROXIMAL END OF THE EXIT PORT AT THE BOND. THE HYPOTUBE WAS STILL INTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443384 ↗
• InjuryAug 8, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT OF THE XACT STENT, THE STENT SYSTEM COULD NOT BE REMOVED FROM THE ANATOMY. A SHUTTLE SHEATH WAS ADVANCED OVER THE DEVICE, AND THE DEVICES WERE ABLE TO BE RETRACTED TOGETHER. DURING THE ATTEMPTS TO REMOVE THE DEVICE, A DISSECTION WAS NOTED UNDER THE STENT. NO TREATMENT WAS PERFORMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 7765527 ↗
• MalfunctionAug 9, 2017Inaccurate Delivery

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE INTERNAL CAROTID ARTERY WITH COMMON CAROTID ARTERY BIFURCATION. MID-WAY THROUGH DEPLOYMENT OF THE XACT 8T X 30 X 136 MM STENT, THE STENT DROPPED TO THE COMMON CAROTID ARTERY DUE TO PATIENT'S AGITATION. THE STENT WAS REMOVED WITH THE GUIDE CATHETER. A NEW XACT STENT 40 MM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6777951 ↗