XACT™ 82088-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648010248), received between Jun 10, 2020 and Mar 2, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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.

• MalfunctionMar 2, 2026Premature Activation

  IT WAS REPORTED THAT AFTER OPENING THE OUTER PACKAGING OF THE 9X30 MM XACT CAROTID SELF-EXPANDING STENT DURING THE PROCEDURE, THE DISTAL END OF THE STENT WAS NOTED TO BE EXPOSED. A NEW UNSPECIFIED CAROTID ARTERY STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24486016 ↗
• MalfunctionAug 27, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE INTERNAL CAROTID ARTERY. A 190CM EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS SUCCESSFULLY DEPLOYED IN THE DISTAL PORTION OF THE LESION. AT THIS POINT A 9SX30MM ON 136CM XACT CAROTID SELF-EXPANDING STENT (SES) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER DURING DEPLOYMENT THE ACCESS SYSTEM [DELIVERY CATHETER] WAS NOTED TO NOT BE STABLE, AND BEFORE THE STENT WAS APPOSED TO THE VESSEL WALL, IT WAS FOUND THAT THE PROTECTIVE FILTER, STENT AND 6FR SHEATH TUBE FELL DOWN [MIGRATED] TO THE AORTIC BRANCH. THEREFORE, THE SURGEON REMOVED THE SES, FILTRATION ELEMENT AND THE SHEATH FROM THE ANATOMY, AND RE-STABILIZED THE VESSEL ACCESS BY REDEPLOYING THE SAME EPS DEVICE AND RE-ADVANCING THE INTRODUCER SHEATH. THE XACT SES WAS REPLACED WITH A 8×40MM XPERT PRO STENT TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY NOR ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907147 ↗
• InjuryJun 10, 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 HEAVILY CALCIFIED LESION IN THE HEAVILY TORTUOUS RIGHT COMMON CAROTID ARTERY. AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS USED AND A VIATRAC 14 DILATATION CATHETER WAS USED FOR POST DILATATION. AFTER THE 9.0X9.0X30 MM XACT STENT WAS IMPLANTED, THE PATIENT EXPERIENCED A DROP IN PULSE AND ASYSTOLE. THE PATIENT WAS STABILIZED WITH CPR AND MEDICATION AND CONTINUED TO BE STABLE. THE PHYSICIAN REPORTED THAT THIS WAS A VERY DIFFICULT CASE DUE TO THE HIGHLY CALCIFIED AREA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 10140841 ↗