XACT™ 83032-01Recalls & reported problems
Abbott Vascular Inc. · XACT™ Transcarotid Stent System 10.0 mm x 30 mm Tapered · Class 3 · Implant
All models of XACT (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648356780), received between Nov 6, 2024 and Nov 6, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE CHIPBOARD BOX OF THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS NOTED TO HAVE THE CATHETER LENGTH LABELED AS "60 MM" RATHER THAN "60 CM". THE CATHETER LENGTH IS LABELED ON NUMEROUS AREAS OF DEVICE, INCLUDING THE CHIPBOARD BOX, POUCH LABEL AND IFU. ALL OTHER LOCATIONS WHERE THE CATHETER LENGTH IS LABELED WERE CORRECT IN INDICATING 60CM. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20623072 ↗MalfunctionNov 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE CHIPBOARD BOX OF THE XACT SELF EXPANDING STENT SYSTEM (SESS) WAS NOTED TO HAVE THE CATHETER LENGTH LABELED AS "60 MM" RATHER THAN "60 CM". THE CATHETER LENGTH IS LABELED ON NUMEROUS AREAS OF DEVICE, INCLUDING THE CHIPBOARD BOX, POUCH LABEL AND IFU. ALL OTHER LOCATIONS WHERE THE CATHETER LENGTH IS LABELED WERE CORRECT IN INDICATING 60CM. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20622417 ↗
Other STENT, CAROTID devices
- Neuroguard IEP® System NG-0740-140-2Contego Medical, Inc. · Stent, Carotid2 recalls32 reports
- Neuroguard IEP® System NG-NV-6-40Contego Medical, Inc. · Stent, Carotid2 recalls9 reports
- Neuroguard IEP® System NG-NV-7-40Contego Medical, Inc. · Stent, Carotid2 recalls8 reports
- ENROUTE Transcarotid Stent SR-0940-CSSilk Road Medical, Inc. · Stent, Carotid1 recall5 deaths58 reports
- Neuroguard IEP® System NG-0640-140-2Contego Medical, Inc. · Stent, Carotid2 recalls7 reports
- ENROUTE Transcarotid Stent SR-1040-CSSilk Road Medical, Inc. · Stent, Carotid1 recall3 deaths56 reports
- CGuard Prime Carotid Stent System CND0840Inspire M.D Ltd · Stent, Carotid1 recall1 death41 reports
- CGuard Prime Carotid Stent System CND0940Inspire M.D Ltd · Stent, Carotid1 recall31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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