XACT™ 82097-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648010330), received between Feb 16, 2022 and Feb 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT INTERNAL CAROTID ARTERY. THE 10X30 MM XACT CAROTID STENT SYSTEM WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE; HOWEVER, WHEN THE DEVICE WAS ASPIRATED, AIR BUBBLES WERE NOTED IN THE NON-ABBOTT SYRINGE SYSTEM. THE DEVICE WAS REMOVED AND AN ACCULINK STENT WAS USED TO COMPLETE THE PROCEDURE. NO AIR WAS IN THE PATIENT. 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 16363885 ↗
• MalfunctionNov 14, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT INTERNAL CAROTID ARTERY WITH MODERATE CALCIFICATION. THE VESSEL SIZE WAS 9-10MM. THE 10X30MM XACT SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS DEPLOYED AND POST-DILATATION WAS PERFORMED WTIH A 5.00X20MM BALLOON. HOWEVER, THE PHYSICIAN FELT THAT STENT WAS TAPERED IN THE INCORRECT DIRECTION OR CAME OFF THE SHAFT BACKWARDS. THE PATIENT RESULTS WERE GOOD. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFCANT DELAY IN THE PROCEDURE. NO ADDTIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794098 ↗
• MalfunctionFeb 16, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, IT WAS NOTED THAT THE TIP OF THE 10X30MM XACT CAROTID SELF-EXPANDING STENT WAS EXPOSED. THE DEVICE WAS NOT USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546423 ↗