Z-1153-2010

Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The Xact Carotid Stent System, used in conjunction with...

Name: Z-1153-2010 Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The Xact Carotid Stent System, used in conjunction with...
Creator: Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Published: 2009-03-19
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2009-03-19 / Terminated / root cause: manufacturing process

FDA source

Abbott Vascular-Cardiac Therapies dba Guidant Corporation began a recall of Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated... on 2009-03-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1153-2010
Status: Terminated
Initiated: 2009-03-19
Posted: 2010-03-16
Terminated: 2012-03-30
Recalling firm: Abbott Vascular
Product: Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) 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.
Product code: NIM Stent, Carotid
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 49
Distribution: Nationwide: GA, NY, IN, LA, MA and PA
Product codes and lots: Lot Number: 9020551

Product code NIM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)