XACT™ 82096-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648010323), received between Aug 25, 2016 and Jun 18, 2025 — classified as 1 death, 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF A 10TX40X136MM XACT BALLOON EXPANDABLE STENT (DES) THAT A TEAR WAS NOTED ON THE INNER STERILE PACKAGE OF THE DEVICE AFTER IT WAS REMOVED FROM ITS OUTER PACKAGING BREACHING THE DEVICE STERILITY. THEREFORE A NEW XACT BES WAS USED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO OTHER DAMAGES LOCATED ON THE PACKAGING NOR THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288161 ↗
• MalfunctionJun 4, 2025Premature Activation; Mechanical Jam; Activation Failure; Premature Activation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 85% STENOSIS. THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION BUT THE KNOB COULD NOT BE TURNED AND THE STENT COMPLETELY FAILED TO DEPLOY. THE STENT WAS NOT EXPOSED OR FLOWERED. THE DEVICE WAS REMOVED FROM THE ANATOMY AND WHEN THE KNOB WAS FORCIBLY TURNED, THE STENT WAS ABLE TO OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS EXPOSED 4 MM FROM THE DISTAL END OF THE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144690 ↗
• InjuryJan 7, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT AN INTERNAL CAROTID ARTERY THAT WAS NOT TORTUOUS NOR CALCIFIED. A 10TX40MM XACT STENT WAS ADVANCED TO THE LESION THROUGH NOTED RESISTANCE PASSING OVER A .014 UNSPECIFIED GUIDE WIRE. DURING DEPLOYMENT OF THE STENT THE MARKERS SEPARATED. THE STENT REMAINED IMPLANTED AND TWO ADDITIONAL UNSPECIFIED STENTS WERE IMPLANTED TO PUSH THE MARKERS INTO THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21091713 ↗
• MalfunctionOct 19, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS INTERNAL CAROTID ARTERY THAT IS 70% STENOSED. THE 10TX40X136 IMPLANTED XACT STENT WAS NOTED TO BE ENTANGLED WITH AN UNSPECIFIED GUIDE WIRE, MAKING IT IMPOSSIBLE TO RECOVER THE EMBOLIC PROTECTION SYSTEM (EPS). A CATHETER WAS USED TO ASSIST TO REMOVED THE EPS/ GUIDE WIRE. THE XACT STENT REMAINED SUCCESSFULLY IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966686 ↗
• MalfunctionOct 12, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE 10X40X136 XACT STENT WAS REMOVED FROM THE TRAY AND THE WIRE OF THE STENT AT THE TIP OF THE SHEATH WAS FOUND PARTIALLY EXPOSED; HOWEVER, NOT FLOWERED. IT WAS ATTEMPTED TO RELEASE THE KNOB AND ROTATE IN THE OPPOSITE DIRECTION; HOWEVER, THE STENT COULD NOT BE COMPLETELY RETRIEVED INTO THE SHEATH. ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO 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 15589498 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A RIGHT INTERNAL CAROTID ARTERY. IT WAS NOTED THE ARTERY HAD VERY SOFT PLAQUE. AN XACT CAROTID STENT SYSTEM WAS INSERTED AND DEPLOYED WITHOUT ISSUES. HOWEVER, AFTER ALL DEVICES WERE REMOVED, THE LEFT SIDE OF THE PATIENT WAS SLOW TO RESPOND. MEDICATIONS WERE ADMINISTERED AND THE PATIENT WAS ABLE TO RECOVER. THE PHYSICIAN STATED THERE WERE NO ISSUES WITH THE DEVICES AND THE STROKE-LIKE SYMPTOMS WERE MORE THAN LIKELY CAUSED BY A PIECE OF SOFT PLAQUE THAT DISLODGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Transient Ischemic Attack

  MAUDE report 13152639 ↗
• InjuryAug 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 10TX40X136 XACT CAROTID STENT WAS IMPLANTED TO TREAT AN OCCLUSION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LEFT VERTEBRAL ARTERY. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A SECOND PLANNED PROCEDURE IN ANOTHER VESSEL; HOWEVER, IT WAS NOTED THAT THE XACT STENT IMPLANTED IN MAY WAS BROKEN CIRCUMFERENTIALLY AND SEVERELY BLOCKING THE BLOOD FLOW. A 7-10/40 ACCULINK STENT WAS IMPLANTED AS TREATMENT, RELIEVING THE PATIENT SYMPTOMS. POST PROCEDURE, THE PATIENT EXPERIENCED A CEREBRAL INFARCTION FROM THROMBUS AND WAS HOSPITALIZED FOR OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 12305091 ↗
• MalfunctionApr 13, 2021Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT AN XACT CAROTID STENT FRACTURED AND FAILED TO DEPLOY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657512 ↗
• DeathJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE OMNILINK ELITE STENT WAS IMPLANTED IN THE SUBCLAVIAN ARTERY AND THE XACT STENT WAS IMPLANTED IN THE INTERNAL CAROTID ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. REPORTEDLY, 8 DAYS LATER, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS REPORTED AS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 8828979 ↗
• InjuryAug 25, 2016Leak/Splash

  IT WAS REPORTED THAT THE XACT STENT DELIVERY SYSTEM WAS PREPARED PER INSTRUCTIONS FOR USE AND THEN ADVANCED TO THE TARGET SITE. A SYRINGE WAS CONNECTED TO THE MANIFOLD AND THE MANIFOLD WAS CONNECTED WITH TUBING TO THE ROTATING HEMOSTATIC VALVE (RHV). THE XACT STENT DELIVERY SYSTEM WAS ADVANCED THROUGH THE RHV. ALL CONNECTIONS WERE NOTED TO BE TIGHT. THE PHYSICIAN PULLED NEGATIVE ON THE SYRINGE AND AIR WAS NOTED IN THE SYRINGE. THE AIR WAS REMOVED AND ONLY BLOOD WAS NOTED DURING NEGATIVE PULL BACK. THE STENT WAS DEPLOYED WITHOUT ISSUE AND THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5904156 ↗