XACT™ 82094-01Recalls & reported problems
Abbott Vascular Inc. · XACT™ Carotid Stent System 7.0 mm x 30 mm Straight · Class 3 · Implant
All models of XACT (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648010309), received between Apr 5, 2021 and Apr 5, 2021 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, NON-TORTUOUS LEFT INTERNAL CAROTID ARTERY THAT WAS 80% STENOSED. AN EMBOSHIELD NAV6 FILTER AND A 7X30MM XACT STENT WERE DEPLOYED IN THE EXTERNAL CAROTID WHEN THEY SHOULD HAVE BEEN DEPLOYED IN THE INTERNAL CAROTID. THE NAV6 WAS REMOVED WITHOUT ISSUE. IT WAS THEN ATTEMPTED TO ADVANCE A NEW EMBOSHIELD NAV6 TO THE INTERNAL CAROTID, BUT IT FAILED TO CROSS DUE TO THE ANATOMY. ENDARTERECTOMY SURGERY WAS THEN PERFORMED TO TREAT THE TARGET LESION AND TO REMOVE THE XACT STENT. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED AS THE PATIENT WAS TAKEN TO SURGERY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11616364 ↗
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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