XACTRecalls & reported problems across all models

We found 19 models of XACT by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 134 adverse event reports in the FDA's MAUDE database, received between Aug 25, 2016 and Jun 3, 2026 — classified as 3 deaths, 58 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported XACT problems

XACT models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• XACT™ 82090-01

  STENT, CAROTID
  1 death46 reports
• XACT™ 82086-01

  STENT, CAROTID
  1 death18 reports
• XACT™ 82087-01

  STENT, CAROTID
  13 reports
• XACT™ 82091-01

  STENT, CAROTID
  12 reports
• XACT™ 82096-01

  STENT, CAROTID
  1 death10 reports
• XACT™ 82092-01

  STENT, CAROTID
  8 reports
• XACT™ 83031-01

  STENT, CAROTID
  4 reports
• XACT™ 82088-01

  STENT, CAROTID
  3 reports
• XACT™ 82097-01

  STENT, CAROTID
  3 reports
• XACT™ 82098-01

  STENT, CAROTID
  3 reports
• XACT™ 83030-01

  STENT, CAROTID
  2 reports
• XACT™ 83029-01

  STENT, CAROTID
  2 reports
• XACT™ 83028-01

  STENT, CAROTID
  2 reports
• XACT™ 83033-01

  STENT, CAROTID
  2 reports
• XACT™ 83032-01

  STENT, CAROTID
  2 reports
• XACT™ 82094-01

  STENT, CAROTID
  1 report
• XACT™ 83025-01

  STENT, CAROTID
  1 report
• XACT™ 83023-01

  STENT, CAROTID
  1 report
• XACT™ 83027-01

  STENT, CAROTID
  1 report

Recent XACT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Premature Activation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED RIGHT INTERNAL CAROTID ARTERY THAT IS 98% STENOSED. DURING ADVANCEMENT OF THE 9X30MM XACT SELF-EXPANDING STENT DELIVERY SYSTEM, THE DELIVERY MECHANISM WAS INADVERTENTLY ACTIVATED RESULTING IN DIFFICULTY ADVANCING AND PARTIAL DEPLOYMENT. AN ACCULINK STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376434 ↗
• MalfunctionMay 18, 2026Premature Activation

  IT WAS REPORTED THAT WHEN THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS OPENED, THE STENT HEAD WAS NOTED TO BE EXPOSED AND NOT FLOWERING/OPENING. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER SAME SIZE XACT SESS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210005 ↗
• MalfunctionMay 15, 2026Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED INTERNAL CAROTID ARTERY. UPON DEPLOYMENT OF THE 9X40MM XACT CAROTID SELF-EXPANDING STENT, A PROBLEM OCCURRED WITH THE DEPLOYMENT MECHANISM [THUMBWHEEL], AND THE STENT COMPLETELY FAILED TO DEPLOY. THE DEVICE WAS TESTED ON THE TABLE AND THE STENT WAS DEPLOYED. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS OBSERVED THERE WAS A SEPARATION NOTED AT THE SHAFT/SHEATH BOND AREA. THE KNOB TURNED, AND THE STENT SHEATH RETRACTED WITH NO RESISTANCE NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188271 ↗
• MalfunctionApr 22, 2026Difficult to Flush; Difficult to Insert

  IT WAS REPORTED THAT DURING PREPARATION, IT WAS FOUND THAT THE TIP OF A 9X7 MM XACT STENT WAS BLOCKED AND WAS UNABLE TO BE FLUSHED. IT WAS ALSO UNABLE TO BE ADVANCED ONTO THE 0.014 INCH GUIDEWIRE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANALYSIS OF THE RETURNED DEVICE NOTED A COMPLETE BLOCKAGE AT THE DISTAL END OF THE TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958432 ↗
• 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 ↗
• MalfunctionFeb 19, 2026Difficult to Remove; Mechanical Jam; Activation Failure

  IT IS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 8TX40MM XACT CAROTID STENT SYSTEM WAS ADVANCED TO THE TARGET LESION ON A 0.014 ABBOTT GUIDE WIRE (GW). THE STENT WAS PARTIALLY RELEASED; HOWEVER, THE HANDLE BECAME STUCK AND THE STENT COULD NOT BE COMPLETELY RELEASED. THEREFORE, CAROTID STENT SYSTEM WAS REMOVED WITH THE SHEATH AND GUIDE CATHETER AS A SINGLE UNIT. THE PROCEDURE WAS CONTINUED WITH ANOTHER XACT STENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393028 ↗
• MalfunctionFeb 5, 2026Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS INTERNAL CAROTID ARTERY THAT IS 80% STENOSED. WHEN ROTATING THE RELEASE KNOB [HANDLE] OF THE 8X40MM XACT CAROTID SELF-EXPANDING STENT (SES), THE STENT WAS PARTIALLY DEPLOYED (EXPOSED). A NEW 6-8X40MM ACCULINK CAROTID SES WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 24273035 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED DE NOVO LESION IN THE LEFT INTERNAL AND COMMON CAROTID ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. A LARGE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS WAS ADVANCE TO THE INTENDED LOCATION AND THE FILTER WAS DEPLOYED. PRE-DILATION WAS PERFORMED WITH A 4X20MM VIATRAC BALLOON, FOLLOWED BY IMPLANTATION OF THE 9-7X30MM XACT STENT. HOWEVER, POST STENT IMPLANTATION THE PATIENT BECAME SYMPTOMATIC WITH APHASIA, RIGHT SIDED HEMIPARESIS, AND DIFFICULTY FOLLOWING COMMANDS. ANGIOGRAPHY REVEALED SLOW BUT COMPLETE FLOW IN THE INTERNAL/EXTERNAL CAROTID ARTERIES AND CEREBROVASCULAR VESSELS. THE STENT WAS CONFIRMED TO BE PATENT. THE PATIENT SYSTOLIC BLOOD PRESSURE WAS NOTED TO BE IN THE 90S. THEREFORE, THE PATIENT WAS TREATED WITH IV PUSH PHENYLEPHRINE TWICE. THE PATIENT'S BLOOD PRESSURE RETURN TO BASELINE OF IN THE 160S AND THE NEUROLOGICAL SYMPTOMS RETURNED TO BASELINE. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Low Blood Pressure/ Hypotension; Stroke/CVA

  MAUDE report 23980183 ↗
• MalfunctionJan 5, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS DEPLOYED. THE XACT SELF EXPANDING STENT SYSTEM (SESS) RELEASED THE STENT BY 1/3 BUT THE REMAINING PORTION COULD NOT BE RELEASED. THE 8FR GUIDING CATHETER THAT WAS ALREADY INSIDE THE ANATOMY WAS USED TO RETRACT THE STENT AND THE EMBOSHIELD NAV6 EPS FILTER WAS REMOVED WHEN THE STENT WAS REMOVED. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23964977 ↗
• MalfunctionJan 2, 2026Activation Failure

  SUBSEQUENT TO THE INITIALLY FILED REPORTS THE DEVICE WAS RECEIVED AND THE STENT WAS NOT DEPLOYED AT ALL. THE ACCOUNT STATED THAT THE PARTIAL DEPLOYMENT WAS REPORTED IN ERROR AND THE STENT COMPLETELY FAILED TO DEPLOY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950822 ↗
• MalfunctionDec 5, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE INTERNAL CAROTID ARTERY. THE 8-6X40MM XACT SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED OVER THE BAREWIRE HOWEVER RESISTANCE WAS MET AND THE SES WAS UNABLE TO ADVANCE. THE SES WAS REMOVED AND THE SHAFT SEPARATED AND THE STENT DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER XACT STENT AND THE SAME BAREWIRE. 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 23727744 ↗
• MalfunctionNov 26, 2025Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED INTERNAL CAROTID ARTERY. THE 8X30X136 XACT STENT WAS ADVANCED TO THE TARGET LESION AND WHEN ATTEMPTING TO DEPLOY THE STENT COMPLETELY FAILED TO DEPLOYED. THERE WAS NO RESISTANCE FELT; HOWEVER, IT WAS NOTED THAT THE DEVICE FELT LOOSER THAN USUAL WHEN ATTEMPTING TO DEPLOY. THEREFORE, ANOTHER UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. PER DEVICE ANALYSIS A SEPARATION WAS NOTED AT THE SHEATH-SHAFT BOND AREA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661071 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2025, TO TREAT A MODERATELY CALCIFIED RIGHT COMMON CAROTID ARTERY AND RIGHT INTERNAL CAROTID ARTERY. THE 8X40MM XACT CAROTID STENT WAS SUCCESSFULLY DEPLOYED IN THE COMMON CAROTID ARTERY. AFTER DEPLOYMENT, THROMBUS WAS NOTED INSIDE THE STENT. THROMBECTOMY WAS PERFORMED AND IMAGING SHOWED "NO FLOW" TO THE BRAIN. THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK WITH FACIAL DROOPING, LEFT SIDE WEAKNESS, THE INABILITY TO SPEAK, PAIN, AND HYPERTENSION. TISSUE PLASMINOGEN ACTIVATOR WAS GIVEN FOR TREATMENT AND THROMBECTOMY WAS PERFORMED AGAIN. BLOOD FLOW WAS RESTORED AND 2 ACUTE CLOTS WERE CAPTURED BY THE FILTER. COMPUTED TOMOGRAPHY SCAN WAS PERFORMED WHICH WAS NEGATIVE FOR EMBOLI. ON (B)(6) 2025, THE PATIENT WAS SENT TO THE ICU FOR FURTHER CARE. THERE WERE NO RESIDUAL DEFICITS AND THE PATIENT WAS ABLE TO PASS NEUROLOGICAL EXAMS. THE HYPERTENSION WAS NOT TREATED, NOR DID IT RESOLVE DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension; Pain; Paresis; Thrombosis/Thrombus; Transient Ischemic Attack

  MAUDE report 23633866 ↗
• MalfunctionNov 20, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY. THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS OPENED BUT IT WAS FOUND THAT THE INNER PACKAGING WAS ALREADY OPENED. THEREFORE THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY ONLY. THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607190 ↗
• MalfunctionNov 13, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, TORTUOUS LEFT CAROTID ARTERY THAT IS 80% STENOSED. A 6FR SHORT SHEATH WAS USED FOR ACCESS AND DIAGNOSTIC IMAGES WERE OBTAINED. THE SHEATH WAS EXCHANGED FOR A 6FR 90CM SHEATH. A EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM WAS ADVANCED WITH RESISTANCE FELT WITH ANATOMY; HOWEVER, DEPLOYED SUCCESSFULLY. THE LESION WAS PRE-DILATED WITH A 4X20MM VIATRAC BALLOON AND A 9TX40X136 XACT CAROTID STENT SYSTEM WAS ATTEMPTED TO BE ADVANCED; HOWEVER COULD NOT ADVANCE DUE TO ANATOMY. A 5.0X30MM VIATRAC BALLOON WAS USED TO DILATE THE LESION AGAIN WITH SUCCESSFUL INFLATION AND THE XACT WAS ATTEMPTED TO ADVANCE VARIETY OF WAYS INCLUDING WITH AN UNSPECIFIED BUDDY WIRE AND MICRO CATHETER; HOWEVER, WAS UNSUCCESSFUL DUE TO ANATOMY. THEN AN UNSPECIFIED ACCULINK STENT SYSTEM ALONG WITH AN UNSPECIFIED SUPPORT CATHETER WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. THE XACT WAS ADVANCED ONE MORE TIME AND WAS ABLE TO CROSS THE LESION; HOWEVER, RESISTANCE WAS MET WITH CALCIUM AND BECAME DIFFICULT TO MANEUVER. DURING REMOVAL THE STENT WAS STUCK IN THE SHEATH AND AND TO HOLD THE SHEATH IN THE GROIN WHILE THE STENT WAS FORCI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547461 ↗

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