Z-1657-2009

Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access...

Name: Z-1657-2009 Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access...
Creator: Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Published: 2009-05-06
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2009-05-06 / Terminated / root cause: manufacturing process

FDA source

Abbott Vascular-Cardiac Therapies dba Guidant Corporation began a recall of Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization on 2009-05-06. The reason FDA records is "Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure". 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-1657-2009
Status: Terminated
Initiated: 2009-05-06
Posted: 2009-07-06
Terminated: 2011-12-21
Recalling firm: Abbott Vascular
Product: Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.
Product code: MGB Device, Hemostasis, Vascular
Reason for recall: Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Between May 6 and May 8, 2009, Sales Representatives visited accounts to recover the product. Recall notifications (Urgent Product Recall letters, dated May 6, 2009) were hand delivered to customers advising them Abbott Vascular is voluntarily recalling one lot of the StarClose Vascular Closure System for a potential stenlity issue discovered internally. Customers are asked to cease use of devices from this lot and work with their local account representative to review their inventory. complete the attached Recall Effectiveness Check Form and rerturn Identified products to Abbott Vascular.
Quantity in commerce: 240 units
Distribution: Nationwide distribution.
Product codes and lots: Lot Number 750406H

Product code MGB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)