XACT™ 83031-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648356674), received between Nov 6, 2024 and May 15, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED INTERNAL CAROTID ARTERY. UPON DEPLOYMENT OF THE 9X40MM XACT CAROTID SELF-EXPANDING STENT, A PROBLEM OCCURRED WITH THE DEPLOYMENT MECHANISM [THUMBWHEEL], AND THE STENT COMPLETELY FAILED TO DEPLOY. THE DEVICE WAS TESTED ON THE TABLE AND THE STENT WAS DEPLOYED. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS OBSERVED THERE WAS A SEPARATION NOTED AT THE SHAFT/SHEATH BOND AREA. THE KNOB TURNED, AND THE STENT SHEATH RETRACTED WITH NO RESISTANCE NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188271 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9TX40 XACT STENT WAS IMPLANTED IN THE LEFT INTERNAL CAROTID AND COMMON CAROTID WITH GREAT POST PROCEDURE FLOW; HOWEVER, 36 HOURS AFTER THE PROCEDURE, THE PATIENT SUFFERED A STROKE AND CONFIRMED VIA CT SCAN. STENT THROMBOSIS WAS CONFIRMED VIA ANGIOGRAM. THEREFORE, THROMBECTOMY WAS PERFORMED IN THE LEFT CAROTID ARTERY AND FLOW WAS RESTORED. THE PATIENT WAS DISCHARGED 24 HOURS LATER WITH ANTI-PLATELET THERAPY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 22580621 ↗
• MalfunctionNov 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON 10/14/2024, THE CHIPBOARD BOX OF THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS NOTED TO HAVE THE CATHETER LENGTH LABELED AS "60 MM" RATHER THAN "60 CM". THE CATHETER LENGTH IS LABELED ON NUMEROUS AREAS OF DEVICE, INCLUDING THE CHIPBOARD BOX, POUCH LABEL AND IFU. ALL OTHER LOCATIONS WHERE THE CATHETER LENGTH IS LABELED WERE CORRECT IN INDICATING 60CM. THE STENT WAS IMPLANTED ON (B)(6) 2024 WITHOUT ISSUE IN THE LEFT INTERNAL CAROTID ARTERY WITH HEAVY CALCIFICATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20624750 ↗
• MalfunctionNov 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CHIPBOARD BOX OF THE EXACT SELF EXPANDING STENT SYSTEM (SESS) WAS NOTED TO HAVE THE CATHETER LENGTH LABELED AS "60 MM" RATHER THAN "60 CM". THE CATHETER LENGTH IS LABELED ON NUMEROUS AREAS OF DEVICE, INCLUDING THE CHIPBOARD BOX, POUCH LABEL AND IFU. ALL OTHER LOCATIONS WHERE THE CATHETER LENGTH IS LABELED WERE CORRECT IN INDICATING 60CM. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622964 ↗