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Terminated

Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.

FDA Recall Z-1152-2010 · Posted 2010-03-16

Recalling FirmAbbott Vascular-Cardiac Therapies dba Guidant Corporation
Recall StatusTerminated
Product CodeNIM
Date Initiated2009-03-19
Date Terminated2012-03-30
Product Quantity49

Reason for Recall

Abbott Vascular is initiating a recall on the XACT Carotid Stent System because the product was distributed prior to approval of a PMA supplement for a manufacturing line move between sites. There are no product quality issues associated with this action.

Firm Action

Notification was sent out to all consignees about the product recall. Representatives from Abbott Vascular personally visited consignees and removed product from site.

Root Cause

PMA

Distribution Pattern

Nationwide: GA, NY, IN, LA, MA and PA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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