Recall Z-1152-2010 ยท NIM Stent, Carotid
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
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.
| Date | Mar 16, 2010 (initiated Mar 19, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | PMA |
| Action | Notification was sent out to all consignees about the product recall. Representatives from Abbott Vascular personally visited consignees and removed product from site. |
| Quantity | 49 |
| Distribution | Nationwide: GA, NY, IN, LA, MA and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.