XACT™ 82098-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648010347), received between Dec 10, 2019 and Jul 24, 2023 — 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.

• MalfunctionJul 24, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE 10X30X136 XACT STENT SYSTEM WAS REMOVED PACKAGING AND NOTED THE TIP OF THE STENT WAS EXPOSED. ANOTHER XACT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. PER DEVICE ANALYSIS THE TIP OF STENT WAS NOTED TO BE EXPOSED; HOWEVER, NOT FLOWERED. THE ACCOUNT CONFIRMED THIS IS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17384064 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTER THAT THE 10X30 MM XACT CAROTID STENT WAS IMPLANTED ONE YEAR AGO IN THE LEFT INTERNAL CAROTID WITH HEAVY CALCIFICATION. APPROXIMATELY 6 MONTHS AFTER THE STENT WAS IMPLANTED, THE PATIENT BEGAN EXPERIENCING HEADACHES, DIZZINESS AND HYPERTENSION AND IN-STENT RESTENOSIS WAS CONFIRMED. THE PATIENT WAS ATTEMPTED TO BE TREATED MEDICALLY; HOWEVER, THE MEDICATION DID NOT SEEM TO ALLEVIATE ANY OF THE SYMPTOMS. A CT SCAN WAS PERFORMED AND IT WAS DECIDED TO PLACE ANOTHER STENT ON (B)(6) 2023 TO TREAT THE IN STENT RESTENOSIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dizziness; Headache; High Blood Pressure/ Hypertension; Stenosis

  MAUDE report 16398570 ↗
• MalfunctionDec 10, 2019Component Missing; Activation Failure; Component Missing; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 95% STENOSED LESION IN THE RIGHT COMMON CAROTID ARTERY. A 10X30MM XACT SELF-EXPANDING STENT SYSTEM (SESS) WAS PREPARED PER THE INSTRUCTIONS FOR USE. FOLLOWING PRE-DILATATION, THE SESS WAS ADVANCED AND THE DEPLOYMENT ACTUATOR WAS ADVANCED WITHOUT ISSUES TO DEPLOY THE STENT; HOWEVER, NO STENT CAME OUT. THE SESS WAS REMOVED WITHOUT ISSUES AND AN ATTEMPT TO DEPLOY THE STENT OUTSIDE THE PATIENT ANATOMY WAS MADE, BUT AGAIN NO STENT CAME OUT. IT WAS REPORTED THAT IT SEEMED AS THOUGH THE STENT WAS MISSING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 10X8MM UNSPECIFIED TAPERED STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS IDENTIFIED THAT THE STENT IMPLANT WAS PARTIALLY EXPOSED FROM THE DISTAL SHEATH AND NOT EXPANDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9446193 ↗