Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The Xact Carotid Stent System, used in conjunction with Emboshield Em
FDA device recall Z-1153-2010 · posted 2010-03-16 · Terminated
Recall details
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- NIM
- Quantity affected
- 49
- Distribution
- Nationwide: GA, NY, IN, LA, MA and PA
- Date initiated
- 2009-03-19
- Date posted
- 2010-03-16
- Date terminated
- 2012-03-30
- Location
- Temecula, CA
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