XACT™ 82092-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648010286), received between Jun 7, 2017 and May 21, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE INTERNAL CAROTID ARTERY. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO ADVANCE THE 8X30MM XACT SELF EXPANDING STENT SYSTEM (SES) TO THE LESION IT WAS NOTED THAT PART OF THE STENT WAS EXPOSED FROM THE OUTER SHEATH. THE SES WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE COMPLETED USING ANOTHER SAME SIZE XACT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357844 ↗
• MalfunctionAug 9, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE INTERNAL CAROTID ARTERY WITH 70% STENOSIS, MILD CALCIFICATION AND MILD TORTUOSITY. THE 8.0X30MM XACT CAROTID STENT SYSTEM WAS ADVANCED, HOWEVER, THE STENT COULD NOT BE RELEASED AND ONLY PARTIALLY DEPLOYED. THERE WAS NO PROBLEM WITH THE DEPLOYMENT MECHANISM. THE STENT SYSTEM WAS REMOVED AND ANOTHER SAME SIZE XACT 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 17487802 ↗
• InjurySep 29, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE COMMON CAROTID ARTERY. DURING DEPLOYMENT, THE XACT STENT JUMPED INTO THE AORTA. THE STENT WAS SNARED AND AN OMNILINK STENT WAS IMPLANTED WITHOUT FURTHER ISSUE TO 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 15508459 ↗
• MalfunctionApr 5, 2022Off-Label Use; Defective Device; Off-Label Use; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 80% STENOSED LESION IN THE LEFT SUBCLAVIAN ARTERY. DURING THE PROCEDURE, A SUITABLE STENT WAS NOT AVAILABLE, SO IT WAS DECIDED TO IMPLANT AN 8X30MM XACT CAROTID SELF-EXPANDING STENT SYSTEM (SESS). AFTER THE SESS WAS IMPLANTED AND FULLY EXPANDED, IT WAS DETERMINED THAT THE STENT WASN'T LONG ENOUGH. THE STENT LENGTH MEASUREMENT WAS TAKEN VIA DIGITAL SUBTRACTION ANGIOGRAPHY (DSA), AND THE LENGTH OF THE STENT WAS DETERMINED TO BE ONLY ABOUT 20MM. IT WAS SUSPECTED THAT THE 20MM STENT WAS PACKAGED INCORRECTLY IN A PACKAGE LABELED 30MM. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018096 ↗
• MalfunctionFeb 28, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED VESSEL IN THE LEFT CAROTID ARTERY. THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS USED AND THE BAREWIRE WAS SWITCHED TO THE 315MM. THE FILTER WAS DEPLOYED. NO PRE-DILATATION WAS PERFORMED. THE XACT CAROTID STENT SYSTEM WAS ATTEMPTED TO BE ADVANCED ON THE BAREWIRE BUT THERE WAS RESISTANCE AND IT ONLY MADE IT INTO THE SHEATH. IT WAS ATTEMPTED TO REMOVE THE DELIVERY SYSTEM BUT IT COULD NOT BE REMOVED EVEN WITH PUSH AND PULL ACTION. ULTIMATELY THERE WAS NO WAY TO RETRIEVE THE FILTER, SO THE FILTER WAS REMOVED OPEN AND TOGETHER WITH THE XACT STENT, THAT WAS NOT DEPLOYED, AND WAS PULLED AS ONE UNIT. ANOTHER EPS, XACT STENT AND BAREWIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS A DELAY IN THE PROCEDURE AS ALL THE DEVICES HAD TO BE TAKEN FROM A DIFFERENT DEPARTMENT BUT THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620414 ↗
• InjuryJan 20, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS A CAROTID ENDARTERECTOMY SURGERY. AN 8X30MM XACT SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LEFT COMMON CAROTID ARTERY, AND DEPLOYMENT WAS INITIATED. AFTER ONE OR TWO ROTATIONS OF THE DEPLOYMENT ACTUATOR, THE STENT JUMPED FORWARD INTO THE AORTIC ARCH BUT REMAINED ON AN UNSPECIFIED GUIDE WIRE. THE STENT WAS RETRIEVED WITH A SNARE, AND AN UNSPECIFIED, OFF-LABEL BALLOON-EXPANDABLE STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE, BUT THERE WAS A CLINICALLY SIGNIFICANT DELAY OF 15-20 MINUTES IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9606892 ↗
• MalfunctionMar 27, 2018Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE COMMON CAROTID ARTERY. THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED WITH RESISTANCE AND TENSION NOTED DUE TO THE ANATOMY, BUT REACHED THE DESIRED LOCATION. AN XACT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED SUCCESSFULLY. DURING WITHDRAWAL OF THE XACT SDS, THE DEVICE BECAME STUCK WITH A KINK IN THE NAV 6 BAREWIRE. THE DISTAL END OF THE 6FR SHEATH WAS ADVANCED UP TO THE FILTER AND ALL DEVICES WERE REMOVED AS ONE WHOLE SYSTEM. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7375048 ↗
• InjuryJun 7, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT INITIALLY PRESENTED WITH SOME SIGNS OF STROKE (BLURRED VISION AND SLIGHTLY IMPAIRED SPEECH), BUT SYMPTOMS RESOLVED JUST PRIOR TO START OF PROCEDURE TO TREAT A HEAVILY CALCIFIED, NON-TORTUOUS RIGHT INTERNAL CAROTID ARTERY (RICA). AN EMBOSHIELD NAV6 LG 190CM EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED PAST THE LESION WITHOUT ISSUE, BUT PATIENT BEGAN TO SHOW SIGNS OF STROKE AGAIN (SAME SYMPTOMS, BUT WORSE THAN PRE-PROCEDURE). WHILE THERE WAS NO DEVICE ISSUE, THE BAREWIRE WAS INADVERTENTLY PULLED BACK, WHICH PULLED THE FILTER BACK TO THE LESION. THE NAV6 FILTER WAS RETRIEVED WITHOUT DIFFICULTY USING THE NAV6 RETRIEVAL CATHETER (RC). A 2ND NAV6 FILTER WAS DEPLOYED WITHOUT ISSUE, PATIENT STROKE SYMPTOMS (LOSS OF SPEECH, LOSS OF VISION) CONTINUED TO WORSEN. AN 8TX40X136 XACT SELF-EXPANDING STENT WAS DEPLOYED WITHOUT DIFFICULTY. ANGIOGRAPHY SHOWED IN-STENT THROMBOSIS WHICH OCCLUDED THE VESSEL. PATIENT EXPERIENCED SEVERE HEADACHE, BECAME COMPLETELY UNRESPONSIVE NEUROLOGICALLY (STROKE WORSENED FURTHER). THE 2ND NAV6 WAS RETRIEVED WITH NAV6 RC WITHOUT DIFFICULTY. A 3RD NAV6 WAS DEPLOYED WITHOUT DIFFICULTY. A 4.5X15X135 RX VIATRAC BALLOON WAS A

  Patient problems: Thrombosis

  MAUDE report 6619780 ↗