XACT™ 82087-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648010231), received between Sep 19, 2016 and Jun 3, 2026 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Premature Activation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED RIGHT INTERNAL CAROTID ARTERY THAT IS 98% STENOSED. DURING ADVANCEMENT OF THE 9X30MM XACT SELF-EXPANDING STENT DELIVERY SYSTEM, THE DELIVERY MECHANISM WAS INADVERTENTLY ACTIVATED RESULTING IN DIFFICULTY ADVANCING AND PARTIAL DEPLOYMENT. AN ACCULINK STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376434 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED DE NOVO LESION IN THE LEFT INTERNAL AND COMMON CAROTID ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. A LARGE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS WAS ADVANCE TO THE INTENDED LOCATION AND THE FILTER WAS DEPLOYED. PRE-DILATION WAS PERFORMED WITH A 4X20MM VIATRAC BALLOON, FOLLOWED BY IMPLANTATION OF THE 9-7X30MM XACT STENT. HOWEVER, POST STENT IMPLANTATION THE PATIENT BECAME SYMPTOMATIC WITH APHASIA, RIGHT SIDED HEMIPARESIS, AND DIFFICULTY FOLLOWING COMMANDS. ANGIOGRAPHY REVEALED SLOW BUT COMPLETE FLOW IN THE INTERNAL/EXTERNAL CAROTID ARTERIES AND CEREBROVASCULAR VESSELS. THE STENT WAS CONFIRMED TO BE PATENT. THE PATIENT SYSTOLIC BLOOD PRESSURE WAS NOTED TO BE IN THE 90S. THEREFORE, THE PATIENT WAS TREATED WITH IV PUSH PHENYLEPHRINE TWICE. THE PATIENT'S BLOOD PRESSURE RETURN TO BASELINE OF IN THE 160S AND THE NEUROLOGICAL SYMPTOMS RETURNED TO BASELINE. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Low Blood Pressure/ Hypotension; Stroke/CVA

  MAUDE report 23980183 ↗
• InjuryDec 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT INTERNAL CAROTID ARTERY WITH HEAVY CALCIFICATION. AN EMBOSHIELD FILTER WAS ADVANCED WITHOUT ISSUES. PRE-DILATATION WAS PERFORMED WITH A 4.0X20MM VIATRAC BALLOON AT 14 ATMOSPHERES (ATMS). THE 9.0X30MM XACT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ONTO THE BAREWIRE AND DEPLOYED. HOWEVER, THE NOSE CONE OF THE XACT DELIVERY SYSTEM BROKE OFF INSIDE THE STENT UPON REMOVAL. ANOTHER GUIDE WIRE WAS ABLE TO ADVANCE THRU THE DELIVERY SYSTEM; HOWEVER, A BALLOON COULD NOT GET THROUGH. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM FOR ENDARTERECTOMY AND WAS ABLE TO CUT THE DISTAL PORTION OF THE BAREWIRE AND THE FILTER. THE CAROTID ARTERY WAS THEN CUT OUT WITH THE DELIVERY SYSTEM, STENT IMPLANT AND THE SEPARATED NOSE CONE WITH IT. THE PATIENT HAS BEEN DISCHARGED AND DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21015381 ↗
• MalfunctionSep 3, 2024Difficult to Remove; Failure to Advance; Difficult to Advance; Difficult to Remove; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY WITHOUT CALCIFICATION AND TORTUOSITY. THE XACT STENT DELIVERY SYSTEM ADVANCED THROUGH THE 6FRENCH (F) SHEATH WITH RESISTANCE BUT FAILED TO CROSS THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY UPON REMOVAL BUT WAS REMOVED INDEPENDENTLY. AN ACCULINK STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 20126896 ↗
• MalfunctionApr 7, 2023Premature Activation; Activation Failure; Premature Activation; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE LEFT INTERNAL CAROTID ARTERY WITH NO NOTED CALCIFICATION OR TORTUOSITY. THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION OVER A .014 NON-ABBOTT GUIDE WIRE AND A 7FR NON-ABBOTT SHEATH WAS USED. THE STENT DID NOT DEPLOY AT ALL WHEN THE THUMBWHEEL WAS TURNED. THERE WAS NO PROBLEM WITH THE DEPLOYMENT MECHANISM. THE SESS WAS REMOVED AND A 10X8X30 AND 7X7X30 XACT STENTS WERE IMPLANTED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT IMPLANT WAS EXPOSED 1.3 MILLIMETERS (MM) FROM THE DISTAL END OF THE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701840 ↗
• MalfunctionNov 2, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE INTERNAL CAROTID ARTERY. A 9TX30MMX136 XACT CAROTID STENT SYSTEM (SESS) WAS ADVANCE TO THE TARGET LESION AND THE ACTUATOR KNOB WAS ROTATED, HOWEVER, THE STENT WOULD NOT DEPLOY. THE ACTUATOR KNOB WAS ROTATED ADDITIONAL TIMES UNTIL THE STENT BECAME EXPOSED BUT NOT EXPANDED. THE DELIVERY SYSTEM WITH THE STENT INTACT WAS REMOVED AND ANOTHER XACT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741457 ↗
• InjuryJul 10, 2021Adverse 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 A LESION IN THE LEFT INTERNAL CAROTID ARTERY. A CAROTID ENDARTERECTOMY WAS PLANNED; HOWEVER, THE PATIENT HAD A LUNG MASS THAT HAD NOT BEEN FOLLOWED-UP ON THEREFORE IT WAS DECIDED TO IMPLANT A CAROTID STENT INSTEAD. A 9TX30MM XACT STENT WAS DEPLOYED PER THE INSTRUCTIONS FOR USE WITHOUT ISSUES. AT THE END OF THE CASE THE PATIENT SHOWED SIGNS OF STROKE WITH RIGHT SIGHTED DEFICIT. THE PATIENT WAS HANDED OVER TO THE STROKE TEAM. THE NEXT DAY THE PATIENT WAS STILL SHOWING RIGHT SIGHTED DEFICIT. THREE DAYS POST-PROCEDURE THE PATIENT WAS STARTING TO SHOW IMPROVEMENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 12148160 ↗
• MalfunctionApr 14, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS RIGHT INTERNAL CAROTID ARTERY. THE XACT STENT DELIVERY SYSTEM WAS ADVANCED AND SOME RESISTANCE WAS NOTED, DUE TO THE PATIENT ANATOMY. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND ADDITIONAL DILATATION WAS PERFORMED. DURING AN ATTEMPT TO RE-INSERT THE XACT STENT DELIVERY SYSTEM, IT WAS NOTED THAT THERE WAS A GAP AT THE TIP OF THE DEVICE AND THE NOSE CONE. THE DEVICE WAS NOT USED AGAIN AND THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. A SECOND XACT STENT DELIVERY SYSTEM WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11664911 ↗
• InjuryDec 9, 2020Adverse 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 CAROTID ARTERY. A XACT STENT WAS IMPLANTED WITHOUT ISSUES AND WORKED AS INTENDED. THE PATIENT WAS FINE AND SENT TO THE POST OPERATION ROOM. HOWEVER, TWO HOURS LATER, THE PATIENT BECAME UNRESPONSIVE AND STARTED SHOWING UNSPECIFIED STROKE SYMPTOMS. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AND DID NOT REVEAL ANY BLEED. THEREFORE, TISSUE PLASMINOGEN ACTIVATOR (TPA) MEDICATION WAS PROVIDED AND THE PATIENT CONDITION IMPROVED. PER THE PHYSICIAN, THE XACT STENT DID NOT CAUSE OR CONTRIBUTE TO THE STROKE SYMPTOMS BUT RATHER THE PATIENTS CLINICAL CONDITION OF CONTRALATERAL OCCLUSION DID. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 10979919 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE XACT STENT WAS SUCCESSFULLY IMPLANTED IN THE INTERNAL CAROTID ARTERY AND THE FILTER WAS SUCCESSFULLY USED AND REMOVED. THERE WAS A LESION DISTAL TO THE STENT THAT THE PHYSICIAN DECIDED NOT TO TREAT AS IT WAS MORE NARROW AND THE FLOW WAS FINE. LATER, WHILE THE PATIENT WAS EATING LUNCH, THEY BEGAN TO EXPERIENCE SYMPTOMS OF A TRANS-ISCHEMIC ATTACK (TIA) WITH WEAKNESS ON THE RIGHT SIDE. A CT SCAN WAS PERFORMED BUT NO OTHER TREATMENT WAS PERFORMED AND THE SYMPTOMS WERE IMPROVING. THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT. THE SYMPTOMS TOTALLY RESOLVED WITHIN 24 HOURS. THE PHYSICIAN NOTED THAT IT WAS LIKELY NOT DUE TO THE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Transient Ischemic Attack; Weakness

  MAUDE report 10466620 ↗
• MalfunctionSep 13, 2018Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY TORTUOUS, CONCENTRIC, 90% STENOSED, PROXIMAL INTERNAL CAROTID ARTERY, DEPLOYMENT OF THE 9X7X30 MM XACT STENT SYSTEM WAS ATTEMPTED, BUT THE STENT ONLY PARTIALLY DEPLOYED. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE. A 9X9X30 MM XACT STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE LESION AND ACHIEVE GOOD BLOOD FLOW. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7874707 ↗
• InjuryMar 22, 2018Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAROTID PROCEDURE ON (B)(6) 2018, TREATING A TARGET LESION IN THE LIGHTLY CALCIFIED RIGHT COMMON CAROTID ARTERY. THE 9.0 X 30 MM XACT STENT WAS DEPLOYED, BUT A DELAY WAS ENCOUNTERED WHILE ATTEMPTING TO SEPARATE THE STENT FROM THE DELIVERY SYSTEM. EVENTUALLY, THE STENT FULLY DEPLOYED IN THE LESION AND THE DELIVERY SYSTEM SUCCESSFULLY REMOVED; HOWEVER, DURING THE DELAY, THE PATIENT EXPERIENCED SEVERE HYPOTENSION, WHICH WAS TREATED WITH NEOSYNEPHRINE. THE PHYSICIAN FELT THE DELAY WAS CLINICALLY SIGNIFICANT. THE PATIENT CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7364552 ↗
• InjurySep 19, 2016Failure to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A HEAVILY CALCIFIED LESION IN THE NON-TORTUOUS RIGHT INTERNAL CAROTID ARTERY, A 6FR SHUTTLE SHEATH WAS ADVANCED TO THE COMMON CAROTID. THE LESION WAS PRE-DILATED WITHOUT ISSUE, USING AN UNSPECIFIED 2.0X20MM TREK BALLOON DILATATION CATHETER (BDC). AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM WAS ADVANCED OVER A BAREWIRE FILTER DELIVERY WIRE AND WAS DEPLOYED WITHOUT ISSUE. ADDITIONAL PRE-DILATATION WAS THEN PERFORMED USING AN UNSPECIFIED 3.5X20 TREK BDC. AN ATTEMPT WAS THEN MADE TO CROSS THE LESION WITH A 9TX30X136 XACT BALLOON EXPANDABLE STENT SYSTEM, BUT THE XACT WAS UNABLE TO CROSS THE LESION DUE TO THE HEAVY CALCIFICATION AND RECOIL OF THE LESION AFTER PRE-DILATATION. ADDITIONAL DILATATION WAS PERFORMED USING A 5.0X20 VIATRAC BALLOON, THEN ANOTHER ATTEMPT TO CROSS WAS MADE USING THE SAME XACT STENT SYSTEM, BUT THE XACT FAILED TO CROSS AGAIN AND THE PATIENT EXPERIENCED A STROKE WITH WEAKNESS IN THE LEFT UPPER EXTREMITIES. MOST OF THE WEAKNESS SELF-RESOLVED WITHOUT MEDICATION OR OTHER INTERVENTION. REPORTEDLY, THE INABILITY TO CROSS WITH THE XACT CONTRIBUTED TO A CLINICALLY SIGNIFICANT DELAY THAT LED TO THE STROKE. AN ATTEMPT WAS T

  Patient problems: Stroke/CVA; Weakness

  MAUDE report 5960618 ↗